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

Primary Purpose

Dystonia, Dystonia, Secondary

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Pallidal (GPi) Deep Brain Stimulation

Thalamic (Vim) Deep Brain Stimulation

GPi + Vim (Multi-Target) Deep Brain Stimulation

Arm Description

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

Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia

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

Outcomes

Primary Outcome Measures

Burke Fahn Marsden Disability Rating Scale (BFMDRS)
SF-36 Quality of Life Scale
Adverse effects of Vim or Vim + GPi Neuromodulation

Secondary Outcome Measures

Full Information

First Posted
November 14, 2016
Last Updated
October 29, 2020
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02982304
Brief Title
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
Official Title
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia, Dystonia, Secondary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pallidal (GPi) Deep Brain Stimulation
Arm Type
Active Comparator
Arm Description
GPi is the standard target for treating most dystonia. This setting will be the active comparator
Arm Title
Thalamic (Vim) Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia
Arm Title
GPi + Vim (Multi-Target) Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Combined stimulation of GPi and Vim stimulation (both electrodes ON)
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation Electrode
Primary Outcome Measure Information:
Title
Burke Fahn Marsden Disability Rating Scale (BFMDRS)
Time Frame
3 months
Title
SF-36 Quality of Life Scale
Time Frame
3 months
Title
Adverse effects of Vim or Vim + GPi Neuromodulation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with hemi-dystonia secondary to stroke Candidate for GPi DBS Able to provide informed consent Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Honey, MD,DPhil,FRCSC
Phone
604-875-5894
Email
chris.honey@telus.net
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Polyhronopoulos, BSc
Phone
778-938-6127
Email
leahpoly@mail.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Honey, MD,DPhil,FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher R Honey, MD, DPhil
Phone
604.875.5894
Email
chris.honey@telus.net

12. IPD Sharing Statement

Citations:
PubMed Identifier
26241157
Citation
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.
Results Reference
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PubMed Identifier
24333801
Citation
Prudente 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.
Results Reference
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Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia

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