Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 14, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 2, 2020
October 1, 2020
6.9 years
November 14, 2016
October 29, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Burke Fahn Marsden Disability Rating Scale (BFMDRS)
3 months
SF-36 Quality of Life Scale
3 months
Adverse effects of Vim or Vim + GPi Neuromodulation
3 months
Study Arms (3)
Pallidal (GPi) Deep Brain Stimulation
ACTIVE COMPARATORGPi is the standard target for treating most dystonia. This setting will be the active comparator
Thalamic (Vim) Deep Brain Stimulation
EXPERIMENTALVim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia
GPi + Vim (Multi-Target) Deep Brain Stimulation
EXPERIMENTALCombined stimulation of GPi and Vim stimulation (both electrodes ON)
Interventions
Deep Brain Stimulation Electrode
Eligibility Criteria
You may qualify if:
- Diagnosed with hemi-dystonia secondary to stroke
- Candidate for GPi DBS
- Able to provide informed consent
You may not qualify if:
- History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms) that may account for dystonia or essential tremor.
- History or evidence of ongoing psychiatric or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease).
- Incompetent adults or those unable to communicate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (2)
Slotty PJ, Poologaindran A, Honey CR. A prospective, randomized, blinded assessment of multitarget thalamic and pallidal deep brain stimulation in a case of hemidystonia. Clin Neurol Neurosurg. 2015 Nov;138:16-9. doi: 10.1016/j.clineuro.2015.07.012. Epub 2015 Jul 29.
PMID: 26241157BACKGROUNDPrudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.
PMID: 24333801BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Honey, MD,DPhil,FRCSC
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 14, 2016
First Posted
December 5, 2016
Study Start
January 1, 2015
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
November 2, 2020
Record last verified: 2020-10