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

University of British Columbia

Status and phase: Unknown; Phase 1

Conditions: Dystonia; Dystonia, Secondary

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02982304

H14-03185

Details and patient eligibility

About

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.

Enrollment: 4 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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4 participants in 3 patient groups

Pallidal (GPi) Deep Brain Stimulation

Active Comparator group

Description:

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

Treatment:

Device: Deep Brain Stimulation

Thalamic (Vim) Deep Brain Stimulation

Experimental group

Description:

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

Treatment:

Device: Deep Brain Stimulation

GPi + Vim (Multi-Target) Deep Brain Stimulation

Experimental group

Description:

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

Treatment:

Device: Deep Brain Stimulation