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

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ClinicalTrials.gov Identifier: NCT02982304
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dystonia Dystonia, Secondary Device: Deep Brain Stimulation Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

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




Primary Outcome Measures :
  1. Burke Fahn Marsden Disability Rating Scale (BFMDRS) [ Time Frame: 3 months ]
  2. SF-36 Quality of Life Scale [ Time Frame: 3 months ]
  3. Adverse effects of Vim or Vim + GPi Neuromodulation [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982304


Contacts
Contact: Chris Honey, MD,DPhil,FRCSC 604-875-5894 chris.honey@telus.net

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Christopher R Honey, MD, DPhil    604.875.5894    chris.honey@telus.net   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Chris Honey, MD,DPhil,FRCSC University of British Columbia

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02982304     History of Changes
Other Study ID Numbers: H14-03185
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases