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Stimulating Specific Brain Areas (VOP/VIM) With Electricity to Improve Movement and Muscle Control

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how deep brain stimulation (DBS), which sends electrical signals to the brain, affects movement, muscle control, and speech. It is for people with essential tremor or Parkinson’s disease who are already scheduled for DBS surgery. During surgery, researchers will also use a temporary electrode on the brain’s surface to send and record electrical signals.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have essential tremor, which causes shaking, that affects one arm more than the other, and be scheduled for DBS surgery at UPMC Presbyterian. The less affected arm will be tested.
  • Or have Parkinson’s disease and be scheduled for DBS surgery at UPMC Presbyterian, with implants aimed at a brain area called the STN.
  • Confirm that joining the study will not change insurance coverage terms for the usual surgery.

Who can't join

  • Have ever had a seizure.
  • Have shaking in both arms that is severe enough to prevent completing the movement tasks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

PA