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 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT06234995
Eligibility Criteria:
Inclusion Criteria for Persons with Parkinson's Disease for Aim 1:
* diagnosis of idiopathic Parkinson's disease (PD)
* Hoehn and Yahr (H\&Y) stage 2-4 (off medication)
Exclusion Criteria for Persons with Parkinson's Disease for Aim 1:
* severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
* inability to hold antiparkinsonian medications for research recordings
* dementia
* non-English speaker
Inclusion Criteria for Persons with Parkinson's Disease for Aim 2:
* diagnosis of idiopathic PD
* there is a clinical indication for DBS surgery
* normal preoperative MRI
* ability to tolerate microelectrode-guided neurosurgery in an awake state
Exclusion Criteria for Persons with Parkinson's Disease for Aim 2:
* presence of a coagulopathy
* uncontrolled hypertension
* heart disease
* other medical conditions considered to increase the patient's risk for surgical complications
Inclusion Criteria for Persons with Parkinson's Disease for Aim 3:
* diagnosis of idiopathic PD
* functioning DBS system
Exclusion Criteria for Persons with Parkinson's Disease for Aim 3:
* severe tremor at rest or severe dyskinesia which would cause significant artifacts in electrophysiological signals
* inability to hold antiparkinsonian medications for research recordings
* inability to tolerate temporary discontinuation of DBS therapy or alteration of stimulation settings for research purposes
* other medical conditions considered to increase the patient's risk for surgical complications
Inclusion Criteria for Healthy Controls:
* age 45-75
Exclusion Criteria for Healthy Controls:
* history of a neuropsychiatric disorder and/or treatment with psychotropic medications
* non-English speaker
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT06234995
Study Brief:
Protocol Section:
NCT06234995