VOP/VIM Direct Electrical Stimulation Increases Motor Cortex Excitability and Motor Output

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In this study the investigators aim to enroll patients scheduled to undergo deep brain stimulation (DBS) implantation for movement disorders for intra-operative testing. In addition to standard-of-care surgical procedure to implant deep brain stimulation electrode leads, participants will also be stimulated and recorded from cortical areas by a temporary strip electrode (1X6) in the subdural space. The electrodes will be connected to external stimulators and a series of experiments will be performed to assess effects of the DBS on movement quality and electrophysiology measures. Results of this study will elucidate the biological mechanisms related to deep brain stimulation in modulating motor and speech function in patients with abnormal movement disorders.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Essential tremor patients who are scheduled to undergo deep brain stimulation surgery at UPMC Presbyterian with asymmetric essential tremor symptoms will be included, with the tested limb corresponding to the least affected arm to better approximate normal function. These patients are implanted bilaterally regardless of symptom laterality, as the natural history of essential tremor indicates eventual bilateral symptoms.

• Parkinson's Disease patients who are scheduled to undergo deep brain stimulation surgery at UPMC Presbyterian with a history of Parkinson's Disease will also be recruited for intra-operative stimulation of their STN-targeted implants, to assess if VIM/VOP has high specificity for improving motor output.

⁃ Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Cierra Clark, MS
cic27@pitt.edu
240-441-4216
Backup
Elvira Pirondini, PhD
elvirap@pitt.edu
412-636-0595
Time Frame
Start Date: 2022-12-16
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Direct Cortical Stimulation and Deep Brain Stimulation of the Motor Thalamus
Individuals undergoing deep brain stimulation device implanted in the motor thalamus for movement disorders treatment. Some of whom may also sustain speech, swallowing, and motor deficits.
Sponsors
Leads: University of Pittsburgh

This content was sourced from clinicaltrials.gov

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