Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2025-12-24 @ 12:33 PM
NCT ID:
NCT07056361
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07056361
Study Brief:
Protocol Section:
NCT07056361