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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132990

Enrollment

Registered

2005-08-22

Start date

2003-02-28

Completion date

2005-09-30

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dystonia

Keywords

Cervical dystonia, Deep brain stimulation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEDeep brain stimulation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement in neck postures/movements	—
Improvement in quality of life	—

Secondary

Measure	Time frame
Document adverse effects of surgery	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026