NCT06951906 Imaging Biomarkers of FOG Response to DBS
| NCT ID | NCT06951906 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of South Carolina |
| Condition | Freezing of Gait Symptoms in Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 54 participants in total. It began in 2024-11-11 with a primary completion date of 2029-11.
⚠ 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
For this study, the investigators are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS, participants will undergo an MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS, participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.
Eligibility Criteria
Inclusion Criteria: 1. \>40 years of age. 2. diagnosis of PD based on UK Brain Bank diagnostic criteria. 3. presence of FOG, defined as a score of 1 on part 1 of the nFOGQ and confirmed by objective evaluation (a score of 1 represents a positive response of having experienced such an episode over the last month). 4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery. Exclusion Criteria: 1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities). 2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices. 3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants. 4. implantation of non-3 T MRI-compatible DBS devices.
Frequently Asked Questions
Who can join the NCT06951906 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Freezing of Gait Symptoms in Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06951906 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06951906 currently recruiting?
Yes, NCT06951906 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical University of South Carolina to inquire about joining.
Where is the NCT06951906 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06951906 clinical trial?
NCT06951906 is sponsored by Medical University of South Carolina. The trial plans to enroll 54 participants.
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