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Search / Trial NCT06951906

Imaging Biomarkers of FOG Response to DBS

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Apr 23, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Freezing Of Gait Parkinson'S Disease Deep Brain Stimulation

ClinConnect Summary

This clinical trial is looking to understand how deep brain stimulation (DBS) affects freezing of gait (FOG) symptoms in people with Parkinson's disease. Freezing of gait is when a person briefly feels unable to move their feet, which can make walking very difficult. The study will involve 54 participants who are over 40 years old, have been diagnosed with Parkinson's disease, and experience FOG symptoms. To join the study, participants need to be selected for DBS surgery at the MUSC DBS Conference.

Participants will go through a series of assessments, including MRI scans and tests related to walking and thinking, both before and after they receive DBS. These assessments will happen over a year, with a total of seven visits. This trial aims to gather valuable information that could help improve treatment options for people experiencing FOG due to Parkinson's disease.

Gender

ALL

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.

About Medical University Of South Carolina

The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.

Locations

Charleston, South Carolina, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported