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

NCT ID: NCT02982304

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dystonia Dystonia, Secondary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Pallidal (GPi) Deep Brain Stimulation

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

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation Electrode

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

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation Electrode

GPi + Vim (Multi-Target) Deep Brain Stimulation

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

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation Electrode

Interventions

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Deep Brain Stimulation

Deep Brain Stimulation Electrode

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Christopher Honey

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chris Honey, MD,DPhil,FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Chris Honey, MD,DPhil,FRCSC

Role: CONTACT

[email protected]
604-875-5894

Leah Polyhronopoulos, BSc

Role: CONTACT

[email protected]
778-938-6127

Facility Contacts

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Christopher R Honey, MD, DPhil

Role: primary

[email protected]
604.875.5894

References

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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.

Reference Type BACKGROUND
PMID: 26241157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24333801 (View on PubMed)

Other Identifiers

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H14-03185

Identifier Type: -

Identifier Source: org_study_id