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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02924194
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed by the subject.
* Parkinson's disease per UK Parkinson's Disease Society Brain Bank (Queens Square) criteria
* Diagnosis of PD-MCI, amnestic subtype per MDS criteria (Level II assessment)
* DBS candidate for GPi targeting per the consensus committee
* 50 - 75 years of age
* Primary English speaking
* Minimum of 10 years of education
* Motorically and cognitively capable of completing evaluations and consent
* Medically cleared for surgery and anesthesia
* Subject must be on stable doses of any medication used to treat PD or cognition for 3 months prior to study entry
* Female subjects with child-bearing potential have a negative serum pregnancy test prior to DBS surgery -
Exclusion Criteria:
* Dementia per DSM-V criteria
* Condition precluding MRI
* History of supraspinal CNS disease other than PD
* Medical condition or required medication compromising cognition
* Alcohol use of more than 4 drinks per day
* Currently uncontrolled moderate-severe depression (BDI\>20)
* History of suicide attempt in the year preceding study screening
* History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
* Use of cholinesterase inhibitor
* Subjects who require rTMS, ECT, diathermy, or repeat MRI procedures to treat a medical condition.
* Subjects with a history of seizure disorder
* Subjects who have made a suicide attempt within the prior year,
* Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
* Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
* Subjects who are pregnant or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT02924194
Study Brief:
Protocol Section:
NCT02924194