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

• Sponsor: University of British Columbia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02982304
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 3
• Duration (Months): 83
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dystonia; Dystonia, Secondary	Device: Deep Brain Stimulation	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pallidal (GPi) Deep Brain Stimulation GPi is the standard target for treating most dystonia. This setting will be the active comparator	Device: Deep Brain Stimulation; Deep Brain Stimulation Electrode
Experimental: 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	Device: Deep Brain Stimulation; Deep Brain Stimulation Electrode
Experimental: GPi + Vim (Multi-Target) Deep Brain Stimulation Combined stimulation of GPi and Vim stimulation (both electrodes ON)	Device: Deep Brain Stimulation; Deep Brain Stimulation Electrode

Outcome Measures

Primary Outcome Measures

1. Burke Fahn Marsden Disability Rating Scale (BFMDRS) [3 months]

2. SF-36 Quality of Life Scale [3 months]

3. Adverse effects of Vim or Vim + GPi Neuromodulation [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vancouver General Hospital	Vancouver	British Columbia	Canada	V5Z 1M9

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Chris Honey, MD,DPhil,FRCSC, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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.

• Responsible Party: Christopher Honey, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT02982304
• Other Study ID Numbers: H14-03185
• First Posted: Dec 5, 2016
• Last Update Posted: Nov 2, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Dystonia; Dystonic Disorders

Study Results

No Results Posted as of Nov 2, 2020