Stimulating the motor thalamus and surface cortex to improve movement and speech
VOP/VIM Direct Electrical Stimulation Increases Motor Cortex Excitability and Motor Output
This test tries brief electrical stimulation of the motor thalamus (VOP/VIM) and nearby cortex during DBS surgery to see if it improves movement, grip strength, and speech in people having DBS for Parkinson's disease, essential tremor, stroke, or brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07056361 on ClinicalTrials.gov |
What this trial studies
Participants already scheduled for deep brain stimulation implantation will have a temporary 1x6 subdural strip placed over primary motor (M1) and somatosensory (S1) cortex for intra-operative recording and direct cortical stimulation. Cortical local field potentials (LFPs) and electromyography (EMG) will be recorded while investigators deliver DBS to the VOP/VIM motor thalamus and perform direct cortical motor-evoked potentials (DCMEPs), comparing thresholds and motor output with and without thalamic stimulation. Patients will perform contralateral hand movement tasks (velocity, grip strength, strength modulation) and speech/articulation exercises during recordings to capture functional changes. The protocol aims to link electrophysiologic changes to measurable motor and speech outcomes to inform how DBS modulates motor circuits.
Who should consider this trial
Good fit: Ideal candidates are adult patients without a seizure history who are scheduled for DBS implantation at UPMC Presbyterian for essential tremor or Parkinson's disease and who can undergo intra-operative cortical recording and stimulation.
Not a fit: Patients with any history of seizures, those not having DBS surgery at the study center, or those unable to tolerate intra-operative testing are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could identify stimulation patterns that improve motor control and speech and help tailor DBS programming to reduce tremor and enhance function.
How similar studies have performed: Related work combining DBS with cortical recordings has yielded mechanistic insights and influenced programming, but using intra-operative cortical stimulation to directly measure VOP/VIM effects is a relatively novel and exploratory approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jorge Gonzalez-Martinez, MD, PhD — University of Pittsburgh
- Study coordinator: Cierra Clark, MS
- Email: cic27@pitt.edu
- Phone: 240-441-4216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.