Deep Brain Stimulation

There are many factors critical to the success of Deep Brain Stimulation. One of the most important is appropriate patient selection.

Parkinson's Disease
Essential Tremor
Dystonia

Parkinson's Disease

Medtronic DBS for Parkinson's Control

Best results are achieved when the patient is fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and self-care responsibilities.

Medtronic DBS for Parkinson's disease Therapy is appropriate for patients who meet the following criteria:

  • Patients should have symptoms of advanced, levodopa responsive Parkinson's disease that are not adequately controlled by medications; and
  • Patients should be suitable candidates for stereotactic neurosurgery.

Before the Medtronic DBS Parkinson's Control System is implanted, the following conditions should be met:

  • Symptom suppression by test stimulation should be demonstrated in the operating room; and
  • Symptom suppression should occur at less than 3 volts, and with minimal side effects such as visual effects and speech difficulties.

Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Clinicians should consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Physicians should be aware that the risks associated with initial surgery may increase with clinical conditions such as:

  • Stroke or neurological disorders other than idiopathic Parkinson's disease
  • Cardiovascular disease
  • Renal or hepatic failure
  • Diabetes mellitus

To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended. Stimulation parameters should be adjusted such that maximal symptom suppression is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement. Patients should be informed of the risks of higher parameters as noted in the Model 3387/3389 DBS Lead Implant Manual.

Use In Specific Populations

The safety and effectiveness of this therapy has not been established for the following:

  • Patients with neurological disease origins other than idiopathic Parkinson's disease
  • Patients with a previous surgical ablation procedure
  • Patients who are pregnant
  • Patients under the age of 18 years
  • Patients over the age of 75 years
  • Patients with dementia
  • Patients with coagulopathies
  • Patients with moderate to severe depression

The Medtronic Patient Referral Advisor software simplifies and clarifies the process of identifying Parkinson's disease patients for referral to a deep brain stimulation (DBS) center or implanter.

Using a clinical questionnaire, the Patient Referral Advisor:

  • Displays a recommendation as "appropriate," "inappropriate," or "uncertain"
  • Creates a patient "appropriateness" profile based on 5 absolute and 7 relative criteria
  • Stores patient profiles and referral information in a registry

Essential Tremor

Medtronic DBS for Essential Tremor Control

Best results are achieved when the patient is fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and self-care responsibilities.

Medtronic DBS for Essential Tremor Therapy is appropriate for patients who meet the following criteria:

  • Patients should have disabling tremor of the upper extremity due to essential tremor or Parkinson's disease.
  • The tremor should constitute a significant functional disability.
  • The tremor should be refractory to pharmacological therapies.
  • Patients should be suitable candidates for stereotactic neurosurgery.

Medtronic DBS Tremor Control Therapy is not intended for the treatment of Parkinson's disease symptoms such as bradykinesia/akinesia, rigidity, and/or postural instability.
Before the system is implanted, the following conditions should be met:

  • tremor suppression by test stimulation should be demonstrated in the operating room; and
  • tremor suppression should occur at less than 3 volts, and with minimal side effects such as paresthesia and speech difficulties.

Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury, or prescribed medications (anticoagulants) that may predispose a patient to the risk of bleeding.

Physicians should be aware that the risk of initial surgery may increase with clinical conditions such as:

  • Stroke or neurological disorders other than Parkinson's disease or essential tremor
  • Cardiovascular disease
  • Renal or hepatic failure
  • Diabetes mellitus

Patients should be carefully selected to assure that their tremor is of physiologic origin. Also, patients must be appropriate candidates for surgery. To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended.

Stimulation parameters should be adjusted such that maximal tremor suppression is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement.

Patients should be informed of the risks of higher parameters as noted in the Warning section of the Model 3387/3389 DBS Lead Implant Manual.

Use in Specific Populations

The safety and effectiveness of this therapy has not been established for the following:

  • Bilateral VIM stimulation
  • Patients with neurological disease origins other than essential tremor or Parkinson's disease
  • Patients with a previous thalamotomy or surgical ablation procedure
  • Pregnancy or delivery
  • Pediatric use (patients under the age of 18)
  • Patients over the age of 80 years

Dystonia

Medtronic DBS for Dystonia*

Best results are achieved when the patient and caregiver are fully informed about the therapy risks and benefits, surgical procedures, follow-up requirements, and self-care responsibilities.

Medtronic DBS Dystonia Therapy is appropriate for patients who meet the following criteria:

  • Patients with chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older
  • Patients should be suitable candidates for stereotactic neurosurgery

Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Physicians should be aware that the risks associated with initial surgery may increase with clinical conditions such as:

  • Stroke or neurological disorders other than idiopathic Parkinson's disease
  • Cardiovascular disease
  • Renal or hepatic failure
  • Diabetes mellitus

To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended. Stimulation parameters should be adjusted such that maximal symptom suppression is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement. Patients should be informed of the risks of higher stimulation parameters, which may result in possible excessive charge density, as noted in the "Programming the Neurostimulator" section of the Model 3387/3389 DBS Lead Implant Manual.

* Humanitarian Device: The effectiveness of this device for the treatment of dystonia has not been demonstrated.

Obsessive-Compulsive Disorder

Medtronic DBS for Obsessive-Compulsive Disorder*

Best results are achieved when the patient and caregiver are fully informed about the therapy risks and benefits, surgical procedures, follow-up requirements, and self-care responsibilities.

Medtronic DBS OCD Therapy is appropriate for patients who meet the following criteria:

  • have a diagnosis of OCD with a documented duration of at least 5 years.
  • have OCD rated as severe or chronic extreme illness.
  • have a Y-BOCS score of ≥30
  • have comorbid depression and anxiety.
  • have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs) with augmentation.
  • do not have hoarding as their primary subclassification.
  • have completed or tried to complete Cognitive Behavior Therapy (CBT).
  • have no serious psychiatric disorder in addition to OCD (e.g. comorbid personality disorder) or substance abuse issues.
  • meet established criteria for implantation of a deep brain stimulation system.
  • are 18 years old or older.
  • have not had a previous surgery to destroy the region of the brain that will be the target of stimulation.
  • are not pregnant.
  • have no other neurological disorders, including dementia.
  • do not have a bleeding disorder or are not taking blood thinners.
  • do not require routine MRIs.

Use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Physicians should consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding.

Physicians should be aware that the risks associated with initial surgery may increase with clinical conditions such as:

  • Stroke or neurological disorders other than idiopathic Parkinson's disease
  • Cardiovascular disease
  • Renal or hepatic failure
  • Diabetes mellitus

To help ensure maximum benefits from the neurostimulation system, long-term, post-surgical management of patients is recommended. Stimulation parameters should be adjusted such that maximal symptom suppression is achieved with minimal side effects. High parameter values may indicate a system problem or less than optimal lead placement. Patients should be informed of the risks of higher stimulation parameters, which may result in possible excessive charge density, as noted in the "Programming the Neurostimulator" section of the Reclaim™ DBS Therapy for OCD Lead Implant Manual.

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

Patient Selection Materials

Patient Referral Advisor for Parkinson's Disease: Sample Case Studies

Rajesh Pahwa, MD. University of Kansas Medical Center, Kansas City, Kansas

This 72-year-old male is recommended as "appropriate" for deep brain stimulation referral.

David Charles, MD Vanderbilt University Medical Center, Nashville, Tennessee

This 61-year-old male is recommended as "inappropriate" for deep brain stimulation referral.

Michael Rezak, MD, PhD Glenbrook Hospital, Glenview, Illinois

This 76-year old female is recommended as "appropriate" for deep brain stimulation referral.

William J. Marks, Jr., MD University of California San Francisco Medical Center, San Francisco, California

This 55-year old male is recommended as "appropriate" for deep brain stimulation referral.

Leo Verhagen, MD, PhD Rush University Medical Center, Chicago, Illinois

This 70-year-old female is recommended as "appropriate" for deep brain stimulation referral.

William J. Marks, Jr., MD University of California San Francisco Medical Center, San Francisco, California

This 61-year-old female is recommended as "appropriate" for deep brain stimulation referral.

Resources for Parkinson's Disease

This brochure provides information about patient selection using the Patient Referral Advisor for Parkinson's disease as well as the methodology that was used to develop the tool.

This scale measures the severity of Parkinson's disease. Stage 1 describes one-sided symptoms. Stage 2 describes bilateral symptoms with no impairment of balance. Stage 3 includes balance impairment with mild to moderate disease but physical independence. Stage 4 patients are severely disabled, but still able to walk or stand unassisted. Stage 5 patients are wheelchair-bound or bedridden unless assisted.

The UPDDF, or UPDRS data form, is simply a worksheet used for recording UPDRS findings.

The UPDRS is a rating tool to follow the longitudinal course of Parkinson's disease. A total of 199 points are possible, with 199 representing the worst disability and 0 representing no disability.