Recruiting
Phase 1

Deep Brain Stimulation

Sponsor:

University of British Columbia

Code:

NCT02982304

Conditions

Dystonia

Dystonia, Secondary

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

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.

Conditions

Dystonia

Dystonia, Secondary

Study ID

NCT02982304

Start date

Jan, 2015

Status verified date

Oct, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

4 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pallidal (GPi) Deep Brain Stimulation

GPi is the standard target for treating most dystonia. This setting will be the active comparator

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

experimental: GPi + Vim (Multi-Target) Deep Brain Stimulation

Combined stimulation of GPi and Vim stimulation (both electrodes ON)

Interventions

Deep Brain Stimulation

Deep Brain Stimulation Electrode

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chris Honey, MD,DPhil,FRCSC

604-875-5894chris.honey@telus.net

Leah Polyhronopoulos, BSc

778-938-6127leahpoly@mail.ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Christopher R Honey, MD, DPhil

604.875.5894chris.honey@telus.net

More Information

Sponsor

University of British Columbia

Last update posted

Nov 2, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-11-02.