Q : What is the brain stimulator Parkinson’s disease therapy? A : Medtronic’s Deep Brain Stimulation Parkinson’s Disease Control Therapy is one of the most progressive treatments for Parkinson’s disease, an innovative Parkinson’s treatment that has been available for over 30 years. The therapy uses two surgical devices similar to pacemakers to deliver electrical stimulation precisely to targeted areas on both sides of the brain. Continuous stimulation of these areas inhibits the transmission of signals that cause symptoms of motor dysfunction. As a result, many patients are able to improve their control of body movements. Q : What does this therapy do? A : Pacemaker Parkinson’s disease control therapy involves electronically stimulating targeted areas of the brain, such as the subthalamic nucleus (STN) or the pallid gyri (GPi), which control motor and muscle function. A wire with tiny electrodes is surgically implanted in the brain and connected by a subcutaneous extension to a neurostimulator implanted near the clavicle. The electrical stimulation can be adjusted according to individual needs and is a non-invasive method of adjustment. Q : Who is suitable for this therapy? A : Patients with Parkinson’s disease who are allergic to levodopa (e.g., methyldopa or tranquilizer) and cannot control their motor symptoms with medication, as well as those who cannot tolerate the side effects of medication, are suitable for this therapy. A “levodopa sensitivity” means that levodopa is effective in treating the main symptoms of Parkinson’s disease. A positive sensitivity to levodopa confirms a diagnosis of Parkinson’s disease rather than other similar symptoms. “Severe” means that the motor disability symptoms of Parkinson’s disease have worsened to the point where normal function cannot be maintained in response to levodopa. This can lead to severe mobility disorders. Patients should not be excluded from pacemaker therapy because of their age or preexisting symptoms (the age range of patients in the clinical trials is 32 to 75 years); however, physicians should carefully consider all factors affecting the patient before making a decision. Q : Can a pacemaker cure Parkinson’s disease? A: There is no cure for Parkinson’s disease. Pacemaker therapy can treat some of the symptoms of Parkinson’s disease and improve its function, but it is not a complete cure. If the therapy is not continued, the patient’s symptoms will reappear. Q : How many people have received pacemaker therapy? A : Since 1997, more than 14,000 patients with spontaneous tremor and Parkinson’s disease have benefited from pacemaker therapy Q : Where can patients receive pacemaker therapy? A : Patients who wish to learn more about pacemaker therapy should first discuss its suitability with their physician. Patients in mainland China can consult the clinical centers referred by the Chinese Parkinson’s Home. Q : Is pacemaker therapy a new approach? What is the history of its development? A : Neurologists and neurologists have been using electrical stimulation to locate and differentiate specific areas of the brain since the 1960s. During this time, they found that stimulating certain structures in the brain produced results that suppressed neurological symptoms such as spontaneous tremors and Parkinson’s disease. Medtronic developed a brain stimulation technique in the 1980’s in conjunction with some of the most prominent internal medicine researchers. In 1987, Professors Alim-Louis Benabid and Pierre Pollak of the University of Grenoble, France, first published the use of deep brain stimulation for the treatment of motor disorders. Since then, Activa therapy has been used in the formal treatment of these two conditions. Pacemaker tremor control therapy was adopted in Canada, Europe and Australia in 1995 and in the United States in 1997. This method uses stimulation of the thalamus to suppress the tremors caused by spontaneous tremors or Parkinson’s disease. The thalamus is the message response center of the brain and is associated with complex motor control. Medtronic’s brain stimulation technology was adopted in the United States in January 2002 and in Canada, Europe and Australia in 1998 for the treatment of patients with severe levodopa-sensitive Parkinson’s disease. Pacemaker Parkinson’s therapy works on the subthalamic nucleus (STN) or pallidopallidum interna (GPi) to suppress the symptoms of Parkinson’s disease. These areas are also involved in complex motor control Q : What are the components of the pacemaker system? A : The pacemaker system consists of 3 implantable components: Lead C is an insulated coil with 4 electrodes attached to the tip that can be implanted in the brain. Extension wire C The extension wire is a thin insulated coil that is sewn under the scalp and extends all the way to the neck and chest, where it is connected to the wire. Neurostimulator C The neurostimulator is a small sealed device similar to a pacemaker, containing a battery and electronics, connected to the extension cord. The neurostimulator is implanted subcutaneously in the chest. It generates the electronic pulses needed to provide stimulation. These electronic pulses are transmitted through the extension cord to a wire and through the wire to the interpallidal or subthalamic nuclei region of the brain. The external components of the system include a physician programmer (to adjust the parameters of the neurostimulator) and a patient hand-held control magnet. The hand-held control magnet is placed on the neurostimulator to activate or deactivate the switch. Q: How does the brain pacemaker work? A: The neurostimulator generates electronic pulses that are then transmitted via an extension cord to target area C, which is the subthalamic nucleus (STN) or pallidopallidum interna (GPi) area of the brain. The physician can adjust the pulse size non-invasively with a physician programmer and transmit the signal to the implanted neurostimulator via a wireless telemetry device. Medical researchers have found that electronic pulses can suppress the signals that trigger Parkinson’s disease symptoms. Patients can turn the neurostimulator on or off by simply placing a small hand-held control magnet on the chest (below the collarbone) for 1 or 2 seconds. Q : How do I implant a pacemaker therapy system? A: The implantation of a pacemaker system can be performed by a central nervous system specialist with stereotactic skills. The neurosurgeon uses a stereotaxic frame and imaging techniques such as magnetic resonance imaging (MRI) or computed tomography (CT) to scan the brain and locate the target area. The wire is inserted through a small hole in the skull and implanted in the target area of the deep brain. Prior to the wire implantation procedure, the patient’s scalp is anesthetized to reduce the patient’s discomfort. The patient is still conscious at this time, so physicians and motor disease specialists can test the stimulation for maximum suppression of Parkinson’s symptoms and minimal side effects. To ensure that the lead is in the most appropriate position, the patient must remain awake during this phase because: ・ the patient must demonstrate symptom suppression (e.g., shaking hands without trembling or rapidly tapping the thumb and index finger simultaneously), ・ the patient must report any side effects to the physician, and ・ the anesthesia may temporarily suppress the symptoms. If the patient’s Parkinson’s disease symptoms are suppressed during the test stimulation, the physician can then implant the neurostimulator with an extension cord. The physician first administers general anesthesia or sedation to the patient. The extension cord is then passed under the scalp, through the neck and shoulder, and into the hole in the wall Q : How long does the hospital stay, surgery and recovery time usually take before surgery? A : The length of hospitalization varies from person to person, but it usually takes only a few days from the pre-surgery hospitalization, surgery to recovery. Q : Is there any follow-up after the transplantation surgery? A : Usually after the surgery, the patient has to come back to the doctor to set up a neurostimulator initiation program to adjust the control of Parkinson’s disease symptoms and reduce the chance of side effects. The physician will then schedule a follow-up date with the patient to adjust to optimal control. Q : Will the pacemaker therapy be visible? A : All the components of the pacemaker system are located inside the body except for the small magnets held in the hands. Depending on the size of the individual, some people have a neurostimulator that looks like a small bump under the skin, but is usually not visible under clothing. Patients may also have a small bump on their head, but it is usually covered by hair and not visible. The surgeon will try to place the neurostimulator where it is most comfortable and least visible to the patient. Q : How long do the batteries in a neurostimulator usually last? A : The battery life varies depending on the parameters set and the number of times the neurostimulator is turned on each day. Under normal settings, the battery usually lasts about 5 years on average, but sometimes it may last less than 5 years due to patient-specific settings, and in a few cases it may last more than 5 years. Replacing the neurostimulator is a simple and minor procedure, and often the extension cord and lead do not need to be replaced. Q : Can the batteries be recharged? A : No. When the neurostimulator battery runs out, the old stimulator must be removed and replaced with a new one. Usually the battery replacement procedure requires only local anesthesia in the clinic Q : What does the stimulation feel like? A : Most patients using the brain stimulator for Parkinson’s disease control therapy do not feel the stimulation, but will feel the effects of the stimulation when their Parkinson’s disease symptoms improve. However, some people may feel a brief tingling sensation when starting the therapy. Q : How do I adjust the stimulation status? A : The physician can adjust the stimulation of the neurostimulator in a non-invasive and painless manner to meet the patient’s needs through a wireless remote control program. Q : How long does it take to return to normal life after a pacemaker procedure? A : Some people are discharged from the hospital on the same day as the transplant surgery, while others need to be hospitalized for a few more days. Most patients recover quickly and experience little or no discomfort during the treatment period. However, patients are advised to avoid strenuous exercise for a few weeks after surgery. Q : Does the pacemaker system produce any noise? A : No. Q : Can the components of the lead (medical coil) of the implanted pacemaker system cause any other harm? A : If the tubing material of the lead coil is damaged, it may cause neurological damage and cancer in animal studies. Q : Can the control magnet of the pacemaker system be placed near a credit or financial card? A : No. The small hand-held magnet of the pacemaker system can have a demagnetizing effect on credit or financial cards. It is best for the patient to keep the control magnet 15 cm (6″) away from such cards. After the system is activated, the physician will give the patient a small card with instructions and precautions. Q : Will the control magnets affect computers, records and other electronic hard devices? A : Yes. Control magnets may have a demagnetizing effect on computer hard drives, CDs and videotapes, so it is best not to place magnets with these items. Q : Does it affect the pacemaker system when the patient is near electronics? A : Sometimes. Most everyday electronic items do not affect the Active system. This includes appliances, computers, office appliances, mobile phones, and personal cordless phones. Neurostimulators may be turned on or off if they are only a few centimeters (inches) away from small magnetic objects such as wireless radios, radios, telephones, magnetic healing products, horseshoes, and refrigerator door magnets. Pacemaker systems may react with certain devices that can generate electromagnetic energy. Security devices and airport/security devices contain high electromagnetic energy and may cause increased irritation and discomfort, so contact with them should be avoided whenever possible. Patients should only use caution when in close proximity to these devices. Detailed instructions for use are provided on the product labeling (included with the product) to inform patients of the precautions to be taken when in close proximity to security devices and airport screening devices. Patients receiving pacemaker therapy will receive a product instruction card containing important information about the system. Patients must carry this card with them at all times. In the event of an accident, the card will inform the patient where to find a facility that can help the patient with the medical device. The card provides basic information about the neurostimulator and data about the physician caring for the patient. The patient can present the ID card to avoid interference with the neurostimulator when passing through or approaching security devices, such as those in stores or airports. Other large devices that may interfere with the switching of the neurostimulator should also be treated with caution. These include large magnetic stereos, MRIs (magnetic resonance imaging), and large factory equipment, electric welders, industrial electric heaters used to bend plastic, electric steel furnaces, electric power lines, and power substations and power farms. Q : Will the implanted pacemaker system affect the results of other medical tests? A : Patients with pacemaker systems should consult their physicians before undergoing any medical tests. When the physician prescribes a test, the patient must inform the physician of the implantation of the Active System. The following may affect the functioning of the pacemaker system: – Electrotherapy for: o Pain relief, muscle stiffness and cramps o Reduction of joint contractures o Reduction of edema and pain after surgery o Increased wound healing which may affect the output of the neurostimulator and/or harm its electronics. Electrotherapy energy can be delivered to the implant system causing tissue damage and may result in serious patient injury or death. The following are some examples. Therapeutic ultrasound, electrolysis, radiotherapy, and electrocautery should not be applied directly to the implant site. ・Diagnostic X-rays are not a problem, but some tests such as mammography that require close contact with the neurostimulator implant site may require separate adjustments to the radiographic equipment. The dentist must be informed of the implantation site of the neurostimulator so that he or she can use the drill and ultrasound probe with care when cleaning the teeth. These devices cannot be applied directly to the implantation site either. Magnetic resonance imaging (MRI) procedures are safe for some patients undergoing pacemaker therapy, but there are still risks involved. This system comes with instructions for using this therapy and includes guidelines for physicians. Patients should inform their physicians of the implantation of this system prior to undergoing MRI. The electric current from the electroshock device may damage the electronics of the neurostimulator. In case of death, the neurostimulator must be removed prior to cremation Q : What is the cost of the pacemaker? A : The overall cost of the system varies from country to country, depending on the length of the patient’s hospital stay and the medical system. The cost of a pacemaker varies depending on the patient’s plan. The cost of bilateral transplantation, including equipment, hospitalization and surgical anesthesia, is approximately US$60,000-$80,000 (USA);$50,000-$60,000 (Taiwan); and about RMB 200,000 in China. This estimate varies depending on the length of hospitalization. Some patients with Parkinson’s disease who receive pacemaker therapy have fewer visits to medical facilities, which reduces their already large medical expenses. For example, fewer medications, fewer companions, etc.