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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT04620551
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide informed consent for this study
* Diagnosis of Idiopathic Parkinson's disease with motor symptoms that have been present for a minimum of 4 years
* Motor symptoms are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS
* UPDRS-III score off medication between 20 and 80, and an improvement in UPDRS-III score on medications of at least 30%, or patients with tremor-dominant PD (score \>/= 2 on UPDRS-III tremor sub-score)-or tremor in addition to other motor symptoms-that is treatment-resistant and results in significant functional disability
* Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms
* Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery
* Absence of significant cognitive deficits or significant depression (BDI-II score \> 20) on formal Neuropsychological Testing
* Age 21 - 80 years
Exclusion Criteria:
* Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia
* Pregnancy
* Significant untreated depression (BDI-II score \> 20)
* Personality or mood disorder symptoms that Study Personnel believe will interfere with study requirements
* Patients requiring ongoing treatment with ECT, rTMS, or diathermy
* Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease) or ferromagnetic metallic implant
* Prior intracranial surgery
* History of, or active, drug or alcohol abuse
* Meets criteria for PD with Mild Cognitive Impairment (PD-MCI), as defined by Performance \> 2 standard deviations below appropriate norms on tests from 2 or more of the following cognitive domains: Attention, Executive Function, Language, Memory, and Visuospatial Ability
* Patients with Restless Leg Syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04620551
Study Brief:
Protocol Section:
NCT04620551