Recruiting

Imaging Biomarkers

Sponsor:

Medical University of South Carolina

Code:

NCT06951906

Conditions

Freezing of Gait Symptoms in Parkinson's Disease

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

fMRI

Study Details

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.

Conditions

Freezing of Gait Symptoms in Parkinson's Disease

Deep Brain Stimulation

Study ID

NCT06951906

Start date

Nov 11, 2024

Status verified date

Aug, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PD Patients with FOG undergoing DBS

Interventions

fMRI

Baseline imaging will utilize advanced diffusion MRI metrics to determine which brain areas are structurally connected to the stimulation target and their structural integrity. Post-operative assessments will include behavioral measures of FOG response and imaging measures of neural response to stimulation. Pre- and post-operative data will be used to evaluate the association between structural integrity, connectivity and behavioral response.

Primary outcome measure

  • Turn Duration [ Time Frame: Assessed at Baseline (Visit 3) and at 12 months post-activation (Visit 7) ]
  • Difference in BOLD Response to STN-DBS [ Time Frame: Assessed post-operatively at 6 months (Visit 5) and 12 months (Visit 6). ]
  • Difference in Structural Connectivity [ Time Frame: Based on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation. ]
  • Difference in Structural Integrity [ Time Frame: Based on baseline diffusion MRI data (Visit 4) and analyzed in relation to DBS response determined at 12 months post-activation. ]

Central Contacts and Locations

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Niloufar Malakouti, M.D.

8437920235malakout@musc.edu

Mahdi Sowlat, M.D.

8438766410sowlat@musc.edu

Principal Investigator:

Gonzalo J. Revuelta, MS, DO, FANA

More Information

Sponsor

Medical University of South Carolina

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Freezing of Gait
  • Parkinson's Disease
  • Deep Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-08-10.