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

Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02982304
• Other study ID #: H14-03185
• Status: Recruiting
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: University of British Columbia
• Contact: Chris Honey, MD,DPhil,FRCSC
• Phone: 604-875-5894
• Email: chris.honey[@]telus.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonia, Secondary
• Dystonic Disorders

Intervention

Device:
• Deep Brain Stimulation
Deep Brain Stimulation Electrode

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burke Fahn Marsden Disability Rating Scale (BFMDRS)		3 months
Primary	SF-36 Quality of Life Scale		3 months
Primary	Adverse effects of Vim or Vim + GPi Neuromodulation		3 months