FAQ

Question : Are there any current safety alerts that I should know about? Rev. 03/03

Answer : Yes. Serious, sometimes fatal, complications resulting from mixing therapeutic procedures.

Inform anyone treating you that you CANNOT have any short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, can cause tissue damage and can result in severe injury or death.
Diathermy can also damage parts of your neurostimulation system. This can result in loss of therapy from your neurostimulation system, and may require additional surgery to remove or replace parts of your implanted device. Injury or damage can occur during diathermy treatment whether your neurostimulation system is turned ?on? or ?off.?

This alert was released by Medtronic, Inc. on May 18, 2001. If you have any questions, please contact Medtronic directly at 1-800-328-0810 or visit their website: www.medtronic.com

Question : What is deep brain stimulation(DBS)? Rev. 02/03

Answer : One of the most exciting neurosurgical advances has been the use of electrical stimulation of specific parts of the nervous system to treat a variety of disabling conditions. These brain stimulation procedures represent a revolutionary new frontier in neurosurgery. Previous neurosurgical procedures employed the destruction or removal of brain tissue. Brain stimulation allows physicians to augment, modulate, and even improve brain function without destroying any area of the brain. Currently, the most common use of brain stimulation is in patients with debilitating movement disorders. This includes essential tremor and Parkinson's disease.
Introduced in the late 1980s by Dr Benabid and colleagues in France, DBS is a surgical procedure consisting of the placement of an electrode or electrodes into one of several possible targets in the brain aided by computer guidance and 3-D physiological mapping. Each electrode is connected to a thin, insulated wire that is threaded under the skin from the top of the skull to the chest. That wire leads to a battery-operated pulse generator (like that used in a pacemaker), which is implanted beneath the skin in the chest. The electrodes send mild electrical pulses to stimulate the brain and block the signals that cause symptoms.
The surgical placement of the electrodes determines their effect, so that they may treat tremor alone (which is all that is needed for a patient with essential tremor), or they may address the range of debilitating symptoms experienced by Parkinson?s patients. Surgeons may recommend the application of DBS to one of three areas of the brain: the thalamus, the subthalamic nucleus, or the globus pallidus.

1. Thalamic Stimulation, electrical stimulation applied to the thalamus, eliminates tremor in more than 80 percent of patients. Most people experience almost complete relief from tremor on the side of the body that corresponds to the stimulation. A small number of patients, however, may receive no benefit.

2. Subthalamic Nucleus Stimulation (STN) is the most promising of the surgical procedures for Parkinson?s disease. Most often it is done bi-laterally (on each side) and it is used to treat not only tremor, but also all of the cardinal symptoms of Parkinson?s disease. In addition, it can virtually eliminate the side effects often caused by the long-term use of anti-parkinsonian drugs. On average, patients can cut their medication dosages in half thereby eliminating the terrible dyskinesias.

3. Globus Pallidal Stimulation. When a patient has already had a unilateral pallidotomy (pallidotomy on one side of the brain), but continues to have dyskinesias on both sides of the body, the surgeon may recommend stimulation of the globus pallidus with a deep brain stimulator. This is a conservative alternative to a bilateral pallidotomy (pallidotomy on both sides of the brain), which destroys brain tissue and risks the permanent impairment of cognition and language function.

The major advantage of DBS over the traditional lesioning procedures is that DBS is reversible and adjustable. DBS causes no destruction of brain tissue and the stimulator can be adjusted, minimized, turned off or even removed if there are untoward side effects. The second major advantage of DBS is that it is adjustable or programmable allowing the stimulation level to be altered to achieve the optimal clinical outcome. For example, if a patient develops increasing rigidity, bradykinesia, or tremor some time after DBS surgery, the stimulation can be modified to achieve better clinical effects, which is not possible with lesioning procedures.

In short, deep brain stimulation technology allows for the optimal scenario in which we can maximize clinical outcome while minimizing complications.

Question : How does DBS/STN work? Rev. 02/03

Answer : Perhaps the most exciting new development for Parkinson's patients is the surgical intervention in the area of the brain called the subthalamic nucleus (STN). The subthalamic nucleus is a structure located deep within the brain that controls many aspects of normal motor function. In Parkinson's disease (PD), the subthalamic nucleus is hyperactive, sending an excess of electrical signals to other parts of the brain. Lesioning the STN, or subthalamotomy, carries a high risk of inducing abnormal movements known as hemiballismus. However, the reversible and adjustable features of DBS have permitted its use in the STN. Electrical stimulation can block the hyperactivity of the STN, and ameliorate many of the symptoms of Parkinson's including rigidity, bradykinesia, postural instability, drug-induced dyskinesias, as well as tremor.

High frequency electrical stimulation is believed to "jam" the signals, normal or abnormal, emanating from the brain site. Stimulation therefore has the same outward effect of a lesion but, unlike a permanent lesion, the effect is reversible. Turn the stimulator off and within minutes to hours, the structure begins to function as it had prior to stimulation. Thus, if stimulation yields an unwanted side effect, the stimulator may be turned off or repositioned. With lesioning procedures, what's done is done.

Question : What is the track-record of STN? Rev. 03/03

Answer : The results have been very encouraging and at times dramatic. In studies using chronic high frequency bilateral STN stimulation, the patients had improvements in the total motor score of 60% with sub-score improvements in bradykinesia, rigidity, tremor, gait and postural instability while off medications. Additionally, there was a reduction in dyskinesias of greater than 70% and reduction of dopaminergic drug dose by more than 50%.

Question : How will I know if the implants are successful? Rev. 03/03

Answer : There are two ways to tell if the implants are of a benefit to you. Firstly, if your "ON" time increases . Secondly if your "OFF" time is not as severe. It takes approximately 2 weeks for the swelling of the brain to go down to normal size after surgery and at that time the first adjustments are possible. Only through reaching an optimum setting can the success of the procedure be gauged. Patience is a key factor and is the most important element in this whole process second only to the skill of the surgical team in locating the exact spot to place the electrodes. Remember that,
1. all patients are unique and therefore reaching the optimum setting can take a number of tries
2) the reason you chose DBS/STN was because it affords the opportunity to correct your symptoms by adjusting the perimeters of the stimulator.

Question : What are the risks of the STN DBS procedure? Rev. 03/03

Answer : The major risk is that of hemorrhage. Even with that knowledge, the risk of brain hemorrhage, (i.e. bleeding in the surgical site), is less than 2%. Routine pre-operative blood tests are performed to determine whether you are at increased risk of bleeding.
Procedures on the left side of the brain (the most common side treated since most patients are right-handed) may result in slurred speech.

Any time hardware is implanted into the human body there is a risk of it causing infection. This is a rare occurrence. However, if it does occur, the device must be removed. You will be given antibiotics during the testing phase and for 48 hours after implantation to reduce the risk of infection.

Risk of neurological complications (i.e. stroke): Implantation may cause damage to critical structures of the brain causing weakness or paralysis, inability to speak. These complications are very rare and are minimized by the use of the stereotactic frame, computer guidance system, and microelectrode recording.
Risk of general anesthesia: These risks include severe allergic reactions to medications, and airway difficulties leading to stroke, heart attack, or death. These occurrences are rare (< 1%) and will be minimized by a complete medical evaluation prior to surgery.

Reversible side effects: Occasionally, the stimulation may induce side effects such as difficulty with eye lid opening, double vision, tingling sensations, and involuntary movements such as chorea, all of which can be alleviated by adjusting stimulation settings.

These are mechanical devices. Wires may break or disconnect. Batteries will certainly need to be changed. All of these repairs require surgery. Breakage of the brain lead requires implantation of a new one. Patients may note painful sensations when the stimulator is first turned on. Typically, this lasts only a few seconds. If these painful sensations last longer, then the device may have to be reprogrammed.

Question : What is the typical length of hospitalization for pre-surgical tests and recovery? Rev. 03/03

Answer : Pre-surgical tests take approximately two days. The patient is hospitalized for approximately a total of five days.

Question : Anything special I should be aware before going into the operation? Rev. 03/03

Answer : YES!!!

1. Bi-lateral STN takes between 5 and 6 hours and you will be AWAKE most of the time. Be aware that each surgical team has its own protocol and the timing and specific steps may vary.
During much of the procedure you need to be awake because your responses are needed to rule out inappropriate and harmful locations for the placement of the four electrodes. You will feel no pain and can converse with the team. Only at the end when the doctors thread the leads and plant the stimulators will you be asleep.

2. I consider this a "no vanity" operation because you will look like hell afterwards. A large bandage is wrapped around your head in turban-like fashion and after it is taken off you are bald. But, within 2 weeks your staples will be removed, the bandage is long gone and you will be ready to begin your adjustment period, i.e., you will be ?turned on? and proper settings of the stimulator will be established.

3. Most patients experience some weight gain because they no longer have extended periods of dyskinesia which tends to burn up many calories. This gain can be anywhere from 10 to 40 lbs.

Question : What is the "halo" and why is it necessary? Rev.03/03

Answer : The "halo" is a device which is secured to the head during the pre-surgical MRI and then is reapplied for the procedure. It is to ensure that there is no movement during the diagnostic testing and surgery. This is done by placing the halo over the head and securing it with 4 screws. For some people this is the most uncomfortable part of the operation.

With the halo's help coded information is fed to the computer and permits the accurate placement of the electrodes by the surgeon.

When I had my halo put on, I was wide-awake. The surgeon took time to discuss my fears, and this part did scare me - more than the surgery. He explained what he'd do; it was similar to getting shots in your mouth before a dental procedure. The first one stung, then nothing. He gave several shots per area but I only felt the first one. He deadened each of the four areas. Four stings, and it was over. The surgical nurse stood behind me and massaged my shoulders the entire time, which really helped. Nothing beats the human touch for comfort.

I think I was mostly nervous about scarring from the halo, and there are NO scars from that!

Question : How long will I be off medication during this procedure? Rev. 03/03

Answer : Generally each patient is off medication 12 hours before the operation, all during the operation and resumes medication after the operation.

Question : What are some of the benefits of DBS/STN? Rev.03/03

Answer : DBS has significantly improved the quality of life for many patients, allowing them to regain independence and resume many normal activities. In clinical studies, most Parkinson?s disease patients experienced improvement in functional ability with DBS/STN.

Deep Brain Stimulation offers many benefits compared with other treatments:
1. DBS/STN is non-destructive and reversible. Other surgical methods such as lesioning (pallidotomy and thalamotomy) permanently destroy brain tissue. But the electrical stimulator can be removed if a new and better therapy is developed in the future.
2. STN may decrease the need for medications and reduce sudden, unpredictable changes in movement (dyskinesias).
3. STN can control the symptoms of Parkinson?s disease on both sides of the body.

Question : What physical changes will there be after surgery? Rev.03/03

Answer : All components, with the exception of the hand held magnet, are inside the body. The stimulator may bulge slightly under the skin, but it isn?t noticeable under clothes. If you have a tendency of developing keloids (heavy scarring tissue), these may become apparent on your chest in time. There also may be a slight bump on the top of the head, but it usually isn't visible under the hair --and yes, your hair will grow back.

Question : What is Parkinson's Disease? Rev. 02/03

Answer : Parkinson's disease is a chronic, progressive neurodegenerative disease characterized by resting tremor, rigidity, bradykinesia, and postural instability. No known treatment has been proven to halt the progression of Parkinson's disease and there is no cure. First described by James Parkinson in 1817, the disease occurs when cells stop functioning in certain parts of the brain that are responsible for sending signals to other brain regions. An essential chemical messenger, or neurotransmitter, called dopamine is missing in that region of the brain that controls movement. This loss is the primary defect in PD, affecting the nerves and muscles controlling movement and coordination.
Pharmacologic treatment with levodopa and adjunctive drugs can usually restore smooth motor function for up to 5-10 years after onset. Levodopa's effectiveness gradually diminishes with time. Eventually, most patients experience drug-related complications, such as motor fluctuations and dyskinesias. The most severe motor complications of levodopa tend to occur among patients with early onset (i.e., before age 40) Parkinson's disease.
Persons with Parkinson's disease can also exhibit symptoms unrelated to the dopaminergic systems. Thus symptoms that are unresponsive to dopamine-active medications ultimately develop. Such symptoms are dementia, and motor symptoms that affect speech, swallowing, and gait, as well as sleep disturbances, fatigue, and depression.
The disease currently affects an estimated one and a half million people in North America alone. Though the actual cause is unknown, many experts feel it is due to an interaction of genetic and environmental factors.

The greatest risk factor is increasing age, so we expect to see a rise in the incidence of Parkinson's as the population ages.

Question : What should I ask the surgical team doctors when considering this surgery? Rev. 03/03

Answer : 1. Am I a good candidate for this procedure? Why? Why not?
2. What are the potential risks and benefits?
3. What are the side effects of the procedure? Can the side effects be controlled?
4. What activities may I be able to resume as a result of the therapy?
5. How likely is it that I will be able to walk, feed myself, write, work, drive and sleep through the night?
6. How should I prepare for surgery?
7. What kinds of tests will be conducted before the surgery?
8. What can I expect the day of surgery?
9. How long does the surgery last? Is it painful?
10. How long will I need to be hospitalized?
11. Will my condition improve immediately after surgery, or will it take more time?
12. What precautions will I need to take after surgery?
13. How often will I need to return for follow-up visits? How many programming sessions to adjust the stimulation can I expect?
14. Will I still need to take medication after having the implants?
15. How much does this procedure cost? Is it covered by insurance or Medicare?
16. How will my drug dosage change after surgery? Immediately after, even before turning on the stimulator? And, once the stimulator is turned on and I am being adjusted? And when I reach an optimal setting?

Question : List of helpful URLs

Answer : Information on Parkinson's disease through articles and videos, focusing on symptoms, treatment and general information.
http://rewiredforlife.healthology.com/focus_index.asp?f=parkinsons_disease

Information on thousands of prescription and over-the-counter medications
http://www.nlm.nih.gov/medlineplus/druginformation.html

Parkinson's Disease Index
Wake Forest University School of Medicine
http://www.wfubmc.edu/surg-sci/ns/pd.html

WE MOVE Web Site: resource for movement disorders research
http://www.wemove.org/

This site is devoted to helping people diagnosed with signs and symptoms of Dystonia regardless of cause or etiology.
http://www.care4dystonia.org/

The Parkinson Archive Treasures
An international email list and website about Parkinson's. Membership is required.
http://www.parkinsons-information-exchange-network-online.com/archive/patp.html

This group is for the discussion of deep brain stimulation surgical procedures. Membership is required.
http://groups.yahoo.com/group/DBSsurgery

National Library of Medicine's PubMed provides access to over 12 million MEDLINE citations and life science journals. Includes links to many sites providing full text articles and other related resources.
http://www.ncbi.nlm.nih.gov/PubMed/

Brain Talk communities' neurology support groups
http://neuro-mancer.mgh.harvard.edu/cgi-bin/Ultimate.cgi

Ask the Surgeon - Jaimie Henderson, M. D., neuro-surgeon from Cleveland Clinic answering questions about DBS.
http://www.parkinson.org/asksurgeon.htm Registration is required

An interesting and informative site on PD on the webmd.com site. http://my.webmd.com/content/dmk/dmk_article_40066

Neurologic Institute of Colorado
http://www.megapathdsl.net/~coloradone/FLASH/download.htm

DBS info on hardware and surgery
http://www.medtronic.com/neuro/parkinsons/activa_qa.html

sites to check for your meds:
http://img.intelihealth.com/
http://www.rxlist.com/

This website lists new medicines currently in clinical trials. Information on medicines for specific diseases (there are several listed for pd) are downloaded in acrobat.
http://www.phrma.org/charts/neurochart99.html

Question : What is involved in stimulator adjustments? Rev. 03/03

Answer : Approximately 14 days after surgery you will be "turned on", i.e., your stimulator will be activated. The specifics of this momentous occasion depend on the team's protocol. It is rare to get a ?best? stimulator setting on the first try. With all the setting parameters that are tried in a programming session the system gets kind of ?numb? and you may not know for about three days what the real effect will be. The setting will be the best that can be found at the time.

Obtaining the optimal stimulation parameters is a time consuming process. During your stimulation programming visits, you will also be instructed on how to turn your stimulator on and off. However, most patients with bilateral subthalamic nucleus DBS opt to keep their stimulators on 24 hours per day, in order to improve not only their daytime mobility, but also their nocturnal mobility and sleep.

Question : What are the hardware components of the DBS system? Rev. 03/03

Answer : The system consists of three implantable components:

Leads: There are metal rings on a lead that transfer electricity to the tissue. The leads are thin, insulated wires with four electrodes at the distal tip that delivers electrical stimulation to the brain. Using standard clinical imaging techniques and stereotactic equipment, the electrode is positioned in the precise location in the sub-thalamic nucleus and then the lead is anchored to the skull. Permanent positioning of the electrode is determined by CAT scan to check for optimal placement.

Extension - An insulated wire that is surgically passed under the skin of the head, neck and shoulder to connect the lead to the implanted pulse generator.

Implantable pulse generator (IPG) - This device, which contains a battery and microelectronic circuitry, is surgically implanted under the skin near the collarbone one on each side for bi-lateral STN. The pulse generator is 2 1/4 in x 2 1/4in. x 3/8 in. and weighs 1.72 oz. The device generates mild electrical pulses that are delivered by the extension and lead to the targeted structures ?the subthalamic nucleus or the globus pallidus.

The stimulation system is designed to deliver high frequency electrical stimulation using a multi-electrode lead places in the Subthalamic Nucleus (STN), Ventral Intermediate Nucleus (Vim) in the thalamus, or the globus pallidus pars interna (Gpi). The implantable pulse generator (IPG) is placed subcutaneously in the pectoral area. The IPG is attached to an extension, which is tunneled and attached to the implanted lead.

External components of the therapy include a console programmer and the patient's hand-held magnet:

Console programmer - The pulses from the IPG can be non-invasively adjusted by the neurologist, from a console programmer and transmitted painlessly via radio telemetry to the implanted device. The initial parameter settings are done on the 14th day after surgery and thereafter re-calibration takes place when needed.

Magnets ? the patient is given 2 magnets to use to turn the IPG on and off. Instances when the patient wants to use the magnet are 1) to limit the number of hours the current is on, for example some patients turn the IPG off for the night, 2) others find that having both sides on increases the likelihood of suffering unwanted symptoms and therefore they chose to improve speech, for example at the detriment to balance and gate. The patient should become comfortable using the magnet by practicing turning on and off.

To safeguard against potential problems, one magnet should be kept in the home and the other one should travel with the patient. It should be kept away from credit cards, computer components.

Cheap AM Radio ? The only way to check whether your system is functioning is by placing an AM radio not tuned to a station over the extension and IPG. The radio will give a humming sound if the devices are connected. If you are concerned that your generator was accidentally turned off by external interference, the radio test is quick and will save you an emergency trip to the doctor.

Question : What questions should you ask before deciding on a team of doctors? Rev. 03/03

Answer : 1. What is the surgeon's training and how long has he/she been performing DBS?
2. Who is on the surgical team?
3. How long has the team worked together?
4. Do the doctors have back-ups? If one is on vacation or leaves the practice, what provisions have they made?
5. How do they select patients?
6. What diagnostic evaluations do they use to make sure you are a good candidate? MRI, full physical exam, EKG, chest x-ray, cardiologist work-up, PET scan, neuropsychological evaluation, cognition evaluation?
7. Does the team do stereotactic procedures? If so, how many have they done?
8. Can they tell you specifically what happens during surgery? And after?
9. What type of surgery does the team specialize in? STN, VIM or Gpi?
10. What are the statistics of the team? Have they encountered problems with hardware failure, incorrect placement of electrode, bleeding, infections, stroke or seizures?
11. How does the team describe the satisfaction level of patients with implants? Would it be possible to speak with a variety of STN patients?
12. Where do you need to go for adjustments?
13. Who will do the adjustments?
14. Are there provisions for "immediately needed" appointments?
15. How often can adjustments be expected?
16. What is the follow-up protocol? How often are evaluations scheduled?
17. Who supervises the medications? Who coordinates the meds with stimulator adjustments? Who prescribes additional/different meds if needed?
18. How comfortable are you with the physician?
19. Do you feel your questions and concerns are addressed?

The second most important aspect of your search is to make sure you have a first-rate neurophysiologist and extremely well trained nurse practitioner to make adjustments to your pulse generator. It may take an extended period of time to find a setting that will give you the best balance between your medications and the stimulator and thus offer optimum benefit of the surgery.

Question : Am I a good candidate for STN stimulation? How can I tell if I will have good results? Rev. 03/03

Answer : Those people who fit the screening criteria have the following characteristics:

1) Have been diagnosed with bilateral idiopathic PD (cause unknown)
2) Are not cognitively or emotionally impaired
3 Your physical condition and age can tolerate the rigorous operation
4) At one time had a good response to levodopa (Sinemet) but at some point the medication has lost its effectiveness and/or the patient is experiencing debilitating side effects
5) You feel that the disease has compromised your Quality of Life. For example, I woke up one morning and decided that I had enough of crawling on all fours during my "off" periods. A quote from Dr. Kelly, my neuro-surgeon, was most persuasive, "after surgery you will consistently feel as good as you do when you are on your best ON."
6) Persons with depression, confusion, and other emotionally related issues should speak to their neurologist honestly and openly.

Question : What will I need to carry with me at all times after the operation? Rev. 03/03

Answer : Post Surgery Essentials Kit

A bag containing items that are necessary whether for a car ride to the local mall or an inter-continental plane ride should contain:

Magnet?one of the two you were given after surgery should be in the bag and the other should be in a safe place at home. This magnet is used to turn the stimulators on and off.
Cautions:
· Credit and Debit Cards-- The hand-held magnet--which turns the system on and off--can erase encoded information on credit and debit cards. Individuals are advised to keep the magnet approximately 6" away from these cards. A small instruction card with complete directions and precautions will be given to the patient after the system is programmed.
· Electronic Hardware-- It is possible that the magnet could erase information on computer hard disks, CDs, and videocassettes, so it is best to keep the magnet away from these items.
· Electrical Devices-- Most of the electrical devices people are around in a normal day will not harm the system. This includes household appliances, computers, office machines, cellular phones, and personal radios. If the neurostimulator comes within inches of small permanent magnets (such as stereo speakers, radios, telephones, magnet therapy products, shoe magnets and refrigerator-door magnets) the neurostimulator could be turned on or off.
· Security Screening Devices?This system may interact with certain types of devices that generate electromagnetic energy. Theft detectors and airport/security screening devices may have enough electromagnetic energy to cause uncomfortable increases in stimulation, and it is best to avoid them if possible. Patients are advised to use care when approaching these devices. Product labeling (packaged with the product) contains detailed instructions for patients when approaching theft detectors and airport security screening devices.
· Other-- Other devices may have enough magnetic field strength to turn the neurostimulator on or off and should be approached carefully. These include: large stereo speakers with magnets, MRI (Magnetic Resonance Imaging) equipment manufacturing and heavy industrial equipment; electric arc welding equipment; electric induction heaters used in industry to bend plastic; electric steel furnaces; power lines; and electric substations and power generators.

Medtronic ID cards?one for each implant. This paper is enclosed in the box that contains your implant. Your doctor will register you and you will then receive the cards by mail. This card should be carried at all times. In the event of an accident, the card will tell those in attendance that a person has an implanted medical device. It supplies basic information about the neurostimulator and identifies the patient's doctor.

Patients may present the ID card when moving through or near security devices (such as those in stores or airports) that may interfere with the neurostimulator.

In addition, this card ensures Medtronic will contact you directly with any new information or safety alerts.

An inexpensive AM radio: Tune it to where you receive the most static and slowly scan each side of your body from the top your head to the imbedded IPG. If the static becomes one continuous tone, you know your implants are functioning.

Pictorial representation (see www.medtronic.com) of implants and leads to take with you when you visit other medical providers. Included with it should be a descriptive paragraph about the hardware. Remember the test results of such tests as MRI, mammograms; EKG, EEG, etc. could be skewed by your implants. Make sure your provider is aware of your condition.
Cautions:
The following procedures may affect your system:
· Diathermy provides optional treatments for the following purposes:
o relieve pain, stiffness and muscle spasms
o reduce joint contractures
o reduce swelling and pain after surgery
o promote wound healing
This may affect the neurostimulator output and/or damage its electronics. Diathermy's energy can be transferred through the implanted system that can cause tissue damage and can result in severe injury or death.
· Therapeutic ultrasound, electrolysis, radiation therapy, and electrocautery also should not be used directly over the implant site.
· Diagnostic x-rays do not cause a problem, but some, such as mammograms, that require tight enclosure of the area where your neurostimulator is implanted, may require additional adjustment of the x-ray equipment.
· Tell your dentist where your neurostimulator is implanted, so he or she can take precautions with dental drills and ultrasonic probes used to clean your teeth. These devices should not be used directly over the implant site.
· Some Magnetic Resonance Imaging (MRI) procedures are safe, but there are risks. Patients are advised to tell physicians who may not know of their implanted system before undergoing MRI.
· The electrical discharges from defibrillators may damage the neurostimulator electronics.
· In the event of patient death, the neurostimulator must be removed prior to cremation.
Take all necessary medications and a timer with you everywhere you go.

Question : What selection criteria are used to increase the likelihood of a successful surgery? Rev. 02/03

Answer : Physicians make use of a battery of tests, including neurological examination, neuropsychological examination, and MRI and PET scanning to identify appropriate candidates for each procedure. Surgical recommendations are made only after a careful analysis of all possible benefits and risks. As surgical teams gain experience, a refinement of the selection process has been made over time. New guidelines are more restrictive and include psychological and mood assessment. The availability of a strong extended support structure made up of family and friends is very important in the recuperation for the patient both immediately after surgery and during the stabilizing stages of adjustments.

Question : How long does the pulse generator battery last? Rev. 03/03

Answer : Battery longevity varies depending upon the parameter settings and number of hours the pulse generator is turned on each day. Estimated longevity is about five years at typical settings, 16 hours of use per day. When the stimulator battery needs to be replaced, the surgeons implant 2 new pulse generators into the chest to replace the existing units. This can be done under local anesthesia but more often than not is done under general anesthesia.
The delicate brain surgery involved in placing the electrodes need not be repeated, nor are the extension and leads replaced.

Question : Who turns on the stimulator? Rev.03/03

Answer : The neurophysiologist, neurologist or,nurse-practitioner will activate the stimulators and determine the correct settings to obtain the maximum clinical benefit with minimal side effects.

Question : What are "nagging side effects" associated with this procedure? Rev.03/03

Answer : Most patients experience some weight gain because they no longer have extended periods of dyskinesia (which tends to burn up many calories). This gain can be anywhere from 10 to 40 lbs.

Patients have also complained of speech problems which never occurred before the surgery. It appears that the stimulators may be a catalyst to the normal speech problems encountered by Parkinson?s patients. Speech therapy is advised but the success is mixed.

Question : Potential hazards in everyday environment. Rev. 03/03

Answer : Credit and Debit Cards-- The hand-held magnet--which is one way to turn the system on and off--can erase encoded information on credit and debit cards. Individuals are advised to keep the magnet approximately 6" away from these cards. A small instruction card with complete directions and precautions will be given to the patient after the system is programmed.

Electronic Hardware-- It is possible that the magnet could erase information on computer hard disks, CDs, and videocassettes, so it is best to keep the magnet away from these items.

Electrical Devices-- Most of the electrical devices people are around in a normal day will not harm the system. This includes household appliances, computers, office machines, cellular phones, and personal radios. If the neurostimulator comes within inches of small permanent magnets (such as stereo speakers, radios, telephones, magnet therapy products, shoe magnets and refrigerator-door magnets) the neurostimulator could be turned on or off.

Security Screening Devices?This system may interact with certain types of devices that generate electromagnetic energy. Theft detectors and airport/security screening devices may have enough electromagnetic energy to cause uncomfortable increases in stimulation, and it is best to avoid them if possible. Patients are advised to use care when approaching these devices. Product labeling (packaged with the product) contains detailed instructions for patients when approaching theft detectors and airport security screening devices.

Other-- Other devices may have enough magnetic field strength to turn the neurostimulator on or off and should be approached carefully. These include: large stereo speakers with magnets, MRI (Magnetic Resonance Imaging) equipment manufacturing and heavy industrial equipment; electric arc welding equipment; electric induction heaters used in industry to bend plastic; electric steel furnaces; power lines; and electric substations and power generators.

Question : A List of Common Terms

Answer : Agonist
An agent capable of stimulating a biological response by occupying cell receptors

Amantadine
An antiviral compound that controls rigidity, bradykinesia, and tremor.

Anticholinergic
A type of drug that relaxes smooth muscle used to treat rigidity, tremor, drooling.

Benserazide
A decarboxylase inhibitor.

Benztropine
An anticholinergic.

Bromocriptine
A dopamine agonist.

Carbidopa
A decarboxylase inhibitor.

COMT Inhibitor
A class of drug that allows more levodopa to cross the blood-brain barrier by blocking enzymes that break down levodopa in the peripheral bloodstream

Decarboxylase Inhibitor
A class of drug that allows more levodopa to cross the blood-brain barrier by blocking enzymes that break down levodopa in the peripheral bloodstream; used to treat nausea and vomiting.

Dopamine
A hormone like substance that is an important neurotransmitter. When present in normal quantities, it facilitates critical brain functions.

Dopamine agonist
A type of drug that binds to dopamine receptors and imitates the action of dopamine.

Dopaminergic
A type of drug with dopamine-like action; used to treat all symptoms of Parkinson?s disease except postural instability. Also refers to systems within the brain that contain dopamine.

Entacapone
A COMT inhibitor.

Inhibitor
A chemical substance that interferes with an enzyme reaction.

Levodopa
The drug most commonly used to treat the symptoms of Parkinson's disease; a dopaminergic.

Lisuride
A dopamine agonist.

MAO B Inhibitor
A class of drug that blocks an enzyme that breaks down dopamine, allowing it to be at the receptor longer; used to treat all symptoms of Parkinson?s disease.

Pergolide
A dopamine agonist.

Pramipexole
A dopamine agonist.

Ropinirole
A dopamine agonist.

Selegiline
An MAO B inhibitor.

Tolcapone
A COMT inhibitor.
Trihexyphenidyl
An anticholinergic generally used to treat Parkinsonian tremor.

Question : How long is the recuperation period after surgery? Rev. 03/03

Answer : Following discharge, patients are told to refrain from strenuous physical activity or heavy lifting for three weeks. In some cases, patients may return to sedentary work one to two weeks following surgery. Patients who do heavy physical activity in the course of their employment are, for disability insurance purposes, considered totally disabled for as long as three months after the surgery.