NCT05822388 Cognitive Decline Following Deep Brain Stimulation
| NCT ID | NCT05822388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.
Eligibility Criteria
PD Participants Inclusion Criteria: * Subjects above 18 years of age * Subjects who will undergo DBS surgery as part of their clinical care for PD Exclusion Criteria: * Uncorrected visual or hearing impairments, as indicated by self-report * Individuals who are pregnant or expect to become pregnant during the course of the study * Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner * COPD with oxygen dependence * Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.) Non-PD Control Participants Inclusion Criteria: * Subjects above 18 years of age * Age matched to participants in PD group Exclusion Criteria: * Diagnosis of Parkinsons Disease or other movement disorder * Untreated neuropsychiatric disorders * Uncorrected visual or hearing impairments, as indicated by self-report * Individuals who are pregnant or expect to become pregnant during the course of the study * Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner * COPD with oxygen dependence * Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
Contact & Investigator
Daniel H Lench, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05822388 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05822388 currently recruiting?
Yes, NCT05822388 is actively recruiting participants. Contact the research team at lenchd@musc.edu for enrollment information.
Where is the NCT05822388 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05822388 clinical trial?
NCT05822388 is sponsored by Medical University of South Carolina. The principal investigator is Daniel H Lench, PhD at Medical University of South Carolina. The trial plans to enroll 80 participants.
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