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Completed

NCT Number: NCT00132990

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

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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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Zelma Kiss, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

Primary outcomes

  1. Improvement in neck postures/movements

  2. Improvement in quality of life

Secondary outcomes

  1. Document adverse effects of surgery

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Calgary Health Region
  • Canadian Institutes of Health Research (CIHR)
  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Aug 22, 2005
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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