ABOUT THE THERAPY: PARKINSON’S DISEASE DEEP BRAIN STIMULATION

Treating the symptoms of Parkinson's Disease with DBS

Deep brain stimulation (DBS) from Medtronic safely and effectively manages tremor, rigidity, and bradykinesia/akinesia associated with Parkinson's disease.1

Dopaminergic medications usually treat motor symptoms of Parkinson's effectively at first. Over time, medications alone often do not work as well as they used to, and Parkinson's symptoms may start affecting quality of life. A patient may also not be able to tolerate medication side effects including dyskinesia. At the time medication alone is not working as well, one option that may be right for your patient is deep brain stimulation with Medtronic DBS Therapy. Medtronic deep brain stimulation may be a therapeutic option for Parkinson's patients with recent or longer-standing motor complications. Consider deep brain stimulation when a patient has symptoms of levodopa-responsive Parkinson's disease of at least 4 years' duration that are not adequately controlled with medication.

DBS Therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. Medtronic DBS Therapy is approved for bilateral stimulation in patients with Parkinson's disease. The implanted system is programmed to customize therapy for the patient.


How It Works

Medtronic Deep Brain Stimulation Therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. For treatment of Parkinson's disease, those areas are the subthalamic nucleus (STN) or internal globus pallidus (GPi).

MEDTRONIC DBS SYSTEM

Deep Brain Stimulation Product Family

Two leads are surgically implanted in the brain and connected to one or two neurostimulators implanted near the collarbone. The neurostimulator contains a small battery and computer chip programmed to send electrical pulses to control symptoms.

A clinician programmer is used to adjust the stimulation to best control the individual's symptoms while minimizing side effects. Periodic adjustments of the programming are a routine part of therapy.

A patient programming device gives patients some control over their settings, within physician-prescribed limits.

RISKS OF THE IMPLANT PROCEDURE

DBS Therapy requires brain surgery. Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, stroke, seizures and infection. Some of these may be fatal. Once implanted, the system may become infected, parts may wear through the skin, and the lead or lead/extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen.


Benefits and Risks

HELPS CONTROL MOTOR FUNCTION

Medtronic deep brain stimulation can improve motor function, improve quality of life, and reduce medication for patients with recent or longer-standing motor complications.

View clinical data

IMPROVES QUALITY OF LIFE

Medtronic deep brain stimulation can improve quality of life and activities of daily living for Parkinson’s patients with recent or longer-standing onset of motor complications.1,2

View clinical data

Daily benefits of the therapy can help patients have a more normal and independent lifestyle:

  • No limitations on clothing, bathing, intimacy, or sleep position
  • No daily maintenance (except for the rechargeable system)
  • 24-hour therapy delivery — does not wear off overnight
  • Simpler medication routine
  • Potential relief from unpleasant drug-related side effects

MEDICATION REDUCTION AND MEDICATION COMPLICATIONS

Medtronic deep brain stimulation can offer Parkinson’s patients a reduction in medication.1

  • DBS showed a 39% statistically significant reduction in medication versus 21% statistically significant increase in dosage in the BMT alone group to 24 months in the study of patients with recent onset of motor complications.1 (A reduction in medication would not be expected in the group taking medication alone.)
  • Medication was reduced by 33.6% with STN and by 16.7% with GPi to 24 months in a study of patients with longer-standing onset of motor complications.1

DBS can improve drug-related complications.1

  • DBS showed a 61% statistically significant reduction compared to a 13% significant increase in BMT alone in drug-related complications including dyskinesias and motor fluctuations at 24 months in the study of patients with recent onset of motor complications.1
  • DBS showed a 44% reduction and BMT had an 8% reduction in drug-related complications to 6 months in the study of patients with longer-standing onset of motor complications. These reductions were sustained in the DBS groups to 24 months: GPi and STN patients had a 46% and 51% improvement, respectively.1

MR CONDITIONAL

Medtronic gives you the first safe* access to MRI anywhere on the body for diagnosing health conditions in patients with deep brain stimulation. Eligible patients with Medtronic DBS Therapy may have an MRI scan anywhere on the body under certain conditions. Refer to MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions and instructions for use.

REVERSIBLE

Unlike lesion procedures such as pallidotomy and thalamotomy, deep brain stimulation is reversible. Therapy may be turned off. In most cases, system components may be removed, preserving options for future therapies and treatments.

SAFETY PROFILE

Medtronic DBS Therapy has been rigorously assessed for safety.

  • Overall serious adverse events (SAE) affected 55.6% of the DBS patients as compared to 44.1% of BMT alone patients in the Level 1 evidence clinical study of patients with recent-onset of motor complications at 24 months. 1% of all patients experienced SAEs that were ongoing when the study was completed.1
  • Overall serious adverse events (SAE) affected 56.5% of the STN patients and 51.0% of GPi patients in the Level 1 evidence clinical study of patients with longer- standing complications at 24 months.1 99% of the serious adverse events were resolved at 6 months with or without sequelae.1

RISKS OF DBS THERAPY

Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through the skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen. Medtronic DBS Therapy may also cause new or worsening neurological, psychiatric, or Parkinson’s-related symptoms.

In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.

This therapy is not for everyone. This therapy should not be used for patients who will be exposed to diathermy (deep heat treatment) or transcranial magnetic stimulation. Magnetic Resonance Imaging (MRI) should only be performed as described in the product labeling. The DBS system may interact with other medical devices and electromagnetic interference.

Healthcare professionals must review the product technical manual prior to use for detailed disclosure. For information refer to Indications, Safety, and Warnings.


*

Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met. If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions.


1

Medtronic DBS Therapy for Parkinson's Disease and Essential Tremor Clinical Summary, 2015.

2

Schuepbach WMM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. February 14, 2013; 368:610-622.