Deep Brain Stimulation

Deep Brain Stimulation for Movement Disorder from Medtronic.

About Deep Brain Stimulation

Deep brain stimulation (DBS) from Medtronic safely and effectively manages some of the most disabling motor symptoms of Parkinson's disease and essential tremor 2. Medtronic DBS enables people suffering from some movement disorders and related symptoms to have greater control over their movements, allowing them to have more freedom to live and work. Medtronic DBS is also approved under an Humanitarian Device Exemption (HDE) for dystonia and obsessive-compulsive disorder (OCD).

DBS uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. It works by electrically stimulating specific structures that control movement and muscle function. For Parkinson's disease (PD), those structures are the subthalamic nucleus (STN) or globus pallidus interna (GPi). For essential tremor (ET), the structure is the ventro intermediate nucleus of the thalamus (Vim), and for dystonia, the GPi or STN is stimulated. For obsessive-compulsive disorder the structure is the anterior limb of the internal capsule (AIC), sometimes referred to as the ventral capsule/ventral striatum (VC/VS).*

Unilateral (for essential tremor) or bilateral (for PD and dystonia) leads are surgically implanted in the brain and connected to one or more neurostimulators implanted near the collarbone. The neurostimulator contains a small battery and computer chip programmed to send electrical pulses to control symptoms. The stimulation may be programmed and adjusted non-invasively by the clinician to help maximize symptom control and minimize side effects.

Indications

Parkinson's Control Therapy:

Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Deep Brain Stimulation for Parkinson's Control is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

Tremor Control Therapy:

Unilateral thalamic stimulation using Medtronic Control is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. The safety or effectiveness of this therapy has not been established for bilateral stimulation.

Dystonia Therapy* :

Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Deep Brain Stimulation for Dystonia is indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older.

Obsessive-Compulsive Disorder Therapy*:

Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

Contraindications for Movement Disorders

Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area, patients who are unable to properly operate the neurostimulator, or for Parkinson's disease and Essential Tremor, patients for whom test stimulation is unsuccessful. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy's energy can be transferred through the implanted system (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.

Contraindications for Obsessive-Compulsive Disorder

Implantation of a Reclaim DBS System is contraindicated for:

  • Patients exposed to diathermy. Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring additional surgery for system explantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned “on” or “off.” Advise your patients to inform all their health care professionals that they should not be exposed to diathermy treatment.
  • Patients exposed to Magnetic Resonance Imaging (MRI). Performing MRI can cause tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis or death.
  • Patients who are unable to properly operate the brain stimulator.
  • Transcranial magnetic stimulation (TMS) is contraindicated for use in patients with an implanted DBS system.
Warning - Electroconvulsive Therapy (ECT) – The safety of ECT in patients who have an implanted deep brain stimulation (DBS) system has not been established. Induced electrical currents may interfere with the intended stimulation or damage the neurostimulation system components resulting in loss of therapeutic effect, clinically significant undesirable stimulation effects, additional surgery for system explantation and replacement, or neurological injury.

* Humanitarian Device: The effectiveness of this device for the treatment of dystonia or obsessive-compulsive disorder has not been demonstrated.

References

  1. Data on file, Medtronic Inc.
  2. Activa Therapy Clinical Summary, 2003.

How it Works

How Deep Brain Stimulation (DBS) Treats Symptoms of Parkinson's Disease, Essential Tremor, Dystonia*, and Obsessive-Compulsive Disorder*.

Deep brain stimulation uses an implanted electrode to deliver electrical stimulation to structures within the brain.

Neurologists and neurosurgeons have used electrical stimulation since the 1960s as a way to locate and distinguish specific sites in the brain. During the process, they discovered that stimulation of certain brain structures suppresses the symptoms of neurological disorders such as essential tremor and Parkinson's disease.

For Parkinson's disease, the targeted areas are the subthalamic nucleus (STN) or the globus pallidus intera (GPi). For essential tremor, the targeted area is the ventral intermediate nucleus of the thalamus (ViM). For dystonia, the targeted area is the STN or GPi. For obsessive-compulsive disorder, the targeted area is the anterior limb of the internal capsule (AIC), more specifically, the ventral capsule/ventral striatum (VC/VS).  

Parkinson's Disease

Medtronic DBS Therapy for Parkinson's disease improves the quantity of “on” time in the STN target population

  • The percentage of time with good mobility without dyskinesia in the waking day increased from 27% to 74% between baseline and six months.
  • 87% of patients demonstrated improved motor scores in the OFF medication state at the 12-month evaluation2
  • Medtronic DBS maintains motor symptom improvements for more than 5 years3

Essential Tremor

  • Unilateral deep brain stimulation resulted in a significant (60% to 90%) reduction of contralateral limb tremor4
  • DBS improves activities of daily living in patients with Essential Tremor2 —69% of patients with Essential Tremor experience total or significant suppression of disabling tremor—significantly reducing disability

Dystonia

Approved in 2003 under Humanitarian Device Exemption (HDE). Refer to indication statement for patient population.

Obsessive-Compulsive Disorder

Reclaim™ DBS Therapy for OCD has been approved by the FDA under a Humanitarian Device Exemption (HDE)* for the treatment of chronic, severe, treatment-resistant OCD as an alternative to anterior capsulotomy. Humanitarian use devices is an FDA classification covering medical devices for the treatment of conditions affecting fewer than 4,000 new patients per year.

The FDA reviewed the safety of the device and determined that the probable health benefits outweigh the risks of injury or illness from its use. Efficacy of treatment, however, has not been established by large clinical trials. Surgery to implant Reclaim DBS Therapy for OCD can only be performed in medical centers that specifically approve its use and have institutional review board approval.

* Humanitarian Device: The effectiveness of this device for the treatment of dystonia or obsessive-compulsive disorder has not been demonstrated.

References

  1. The Deep-Brain Stimulation for Parkinson's Disease Study Group. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001;345:956-963.
  2. Activa Therapy Clinical Summary, 2003.
  3. Krack P, Batir A, Van Blercom N, et al. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 2003;349:1925-1933.
  4. Zesiewicz TA, Elble R, Louis ED, et al. Practice paramater: therapies for essential tremor: Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005;64:2008-2020.