NCT07056361 Stimulating Specific Brain Areas (VOP/VIM) With Electricity to Improve Movement and Muscle Control
| NCT ID | NCT07056361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jorge Gonzalez-Martinez |
| Condition | Movement Disorders (Incl Parkinsonism) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-12-16 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-12-16 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients will be excluded from the study if there is any seizure history, to avoid the increased epileptogenic risk of intraoperative stimulation. * Patients with significant bilateral tremor that precludes completion of motor tasks.
Contact & Investigator
Jorge Gonzalez-Martinez, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07056361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Movement Disorders (Incl Parkinsonism). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07056361 currently recruiting?
Yes, NCT07056361 is actively recruiting participants. Contact the research team at cic27@pitt.edu for enrollment information.
Where is the NCT07056361 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07056361 clinical trial?
NCT07056361 is sponsored by Jorge Gonzalez-Martinez. The principal investigator is Jorge Gonzalez-Martinez, MD, PhD at University of Pittsburgh. The trial plans to enroll 60 participants.
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