Identifying brain biomarkers for cognitive decline after Deep Brain Stimulation in Parkinson's Disease
A Neural Basis for Cognitive Decline Following Deep Brain Stimulation
Medical University of South Carolina · NCT05822388
This study is trying to find brain markers that can help predict how people with Parkinson's Disease will think and remember after getting Deep Brain Stimulation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05822388 on ClinicalTrials.gov |
What this trial studies
This research aims to identify MRI-based brain biomarkers that predict how individuals with Parkinson's Disease respond to Deep Brain Stimulation (DBS) and to assess cognitive changes associated with the procedure. A total of 55 participants with Parkinson's Disease, who are scheduled for DBS, will undergo a series of visits including screening, MRI scanning, and cognitive assessments. Additionally, control participants without Parkinson's Disease will also be recruited for comparative MRI and cognitive evaluations. The study seeks to understand factors contributing to cognitive decline post-DBS, which could enhance patient selection and optimize stimulation targets.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are planning to undergo DBS surgery for Parkinson's Disease.
Not a fit: Patients with uncorrected visual or hearing impairments, claustrophobia, or those with non-MRI compatible implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for DBS surgery and strategies to minimize cognitive side effects.
How similar studies have performed: While there is existing research on DBS and cognitive outcomes, this specific approach focusing on MRI biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel H Lench, PhD — Medical University of South Carolina
- Study coordinator: Daniel H Lench, PhD
- Email: lenchd@musc.edu
- Phone: 843-792-9115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson Disease, Movement Disorders