A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-09-30

Brief Summary

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The purposes of this study are:

* to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements;
* to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and
* to document the adverse effects of surgery in patients with cervical dystonia.

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Detailed Description

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Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.

The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.

Conditions

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Cervical Dystonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Deep brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients, male or female
* Diagnosed with cervical dystonia by a movement disorders neurologist
* Has cervical dystonia alone, not generalized or multifocal
* Has had adequate trials of medical therapy

Exclusion Criteria

* Cognitive impairment
* Abnormalities on pre-operative magnetic resonance imaging (MRI)
* Medical conditions precluding general anaesthetic or surgery
* Unstable psychiatric disease
* Previous brain lesions to treat cervical dystonia

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No