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Status:

COMPLETED

Deep Brain Stimulation for Cervical Dystonia

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Dystonia

Generalized Primary Dystonia

Eligibility:

All Genders

7-70 years

Phase:

PHASE2

Brief Summary

This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating primary generalized dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repe...

Detailed Description

OBJECTIVE: For dystonic patients who have failed medical therapy, stereotactic deep brain stimulation (DBS) of the globus pallidus interna (Gpi) or subthalamic nucleus (STN) can provide significant s...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • To be eligible for entry into the study, candidates must meet all the following criteria:
  • Patients greater than 7 years of age with generalized primary dystonia.
  • Patients who are refractory to medical treatment (including levodopa, anticholinergics, benzodiazepines, Baclofen) who are considered surgical candidates. Patients will be determined to have medical refractory dystonia after having been treated by at least two medications of two different groups at the maximum recommended dose for a duration of at least two months.
  • In case of treatment by intrathecal Baclofen delivered by a pump, a change to oral Baclofen must be performed, so that the pump can be taken out.
  • Patients must have a minimum BFM score of 20 on optimal medical therapy.
  • Adults must be mentally competent to consent for entrance into the protocol at the time of admission.
  • Patients must have a signed DPA for research purposes.
  • EXCLUSION CRITERIA:
  • Candidates will be excluded if:
  • The patient has had previous lesioning surgery including radiofrequency lesioning of deep nuclei (thalamus, pallidum, STN).
  • The patient currently has a functioning and effective stimulator in deep brain nuclei (thalamus, pallidum, STN).
  • The patient is not able to tolerate surgery, as determined by the preoperative evaluation.
  • The patient has a coagulopathy demonstrated by an abnormal prothrombin time, activated partial thromboplastin time, or thrombocytopenia (platelet count less than 150,000 platelets/mm(3)).
  • The patient has an acute or untreated infection (viral, bacterial or fungal).
  • The patient has a contraindication to MR-imaging such as previous surgery that involved placement of metal objects that could cause tissue damage or produce image artifacts.
  • The patient has another chronic neurologic disorder.
  • The patient is pregnant at the time of surgery.
  • The patient has epilepsy.
  • The patient does not have access to proper follow-up care at home and may not be eligible for the study.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    July 1 2006

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00105430

    Start Date

    March 1 2005

    End Date

    July 1 2006

    Last Update

    July 6 2006

    Active Locations (1)

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    1

    National Institute of Neurological Disorders and Stroke (NINDS)

    Bethesda, Maryland, United States, 20892