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Status:

COMPLETED

Deep Brain Stimulation to Treat Cervical Dystonia

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Cervical Dystonia

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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

Detailed Description

Objective: For patients with cervical dystonia who have failed medical therapy, stereotactic deep brain stimulation (DBS) of the globus pallidus interna (Gpi) or subthalamic nucleus (STN) can provide ...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA
  • To be eligible for entry into the study, candidates must meet all the following criteria:
  • Patients 18 years of age or older with primary cervical dystonia.
  • Patients who are refractory to medication (to medications including; levodopa, anticholinergics, benzodiazepines, Baclofen) and 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 primary (idiopathic) cervical dystonia.
  • Patients must have a minimum TWSTRS of 20 on optimal medical therapy.
  • Patients must be mentally competent to consent for entrance into the protocol at the time of admission, or have legal guardian consent for them.
  • 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 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 may not be eligible for the study.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    July 1 2006

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00132340

    Start Date

    August 1 2005

    End Date

    July 1 2006

    Last Update

    July 6 2006

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institute of Neurological Disorders and Stroke (NINDS)

    Bethesda, Maryland, United States, 20892