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

U

University of Calgary

Status

Completed

Conditions

Cervical Dystonia

Treatments

Device: Deep brain stimulation

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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