Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia

October 29, 2020 updated by: Christopher Honey, University of British Columbia
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosed with hemi-dystonia secondary to stroke
  2. Candidate for GPi DBS
  3. Able to provide informed consent

Exclusion Criteria:

  1. History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
  2. History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
  3. Incompetent adults or those unable to communicate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pallidal (GPi) Deep Brain Stimulation
GPi is the standard target for treating most dystonia. This setting will be the active comparator
Device: Deep Brain Stimulation
Deep Brain Stimulation Electrode
Experimental: Thalamic (Vim) Deep Brain Stimulation
Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia
Device: Deep Brain Stimulation
Deep Brain Stimulation Electrode
Experimental: GPi + Vim (Multi-Target) Deep Brain Stimulation
Combined stimulation of GPi and Vim stimulation (both electrodes ON)
Device: Deep Brain Stimulation
Deep Brain Stimulation Electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Burke Fahn Marsden Disability Rating Scale (BFMDRS)
Time Frame: 3 months
3 months
SF-36 Quality of Life Scale
Time Frame: 3 months
3 months
Adverse effects of Vim or Vim + GPi Neuromodulation
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Chris Honey, MD,DPhil,FRCSC, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-03185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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