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

Phase 1

• Conditions: Dystonia, Secondary; Dystonia
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02982304
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Diagnosed with hemi-dystonia secondary to stroke
2. Candidate for GPi DBS
3. Able to provide informed consent

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pallidal (GPi) Deep Brain Stimulation	Deep Brain Stimulation	GPi is the standard target for treating most dystonia. This setting will be the active comparator
GPi + Vim (Multi-Target) Deep Brain Stimulation	Deep Brain Stimulation	Combined stimulation of GPi and Vim stimulation (both electrodes ON)
Thalamic (Vim) Deep Brain Stimulation	Deep Brain Stimulation	Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia

Primary Outcome Measures

Name	Time	Method
Burke Fahn Marsden Disability Rating Scale (BFMDRS)	3 months
Adverse effects of Vim or Vim + GPi Neuromodulation	3 months
SF-36 Quality of Life Scale	3 months

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada