Actively Recruiting
Accelerated TMS for Freezing of Gait in Parkinson's Disease
Led by Medical University of South Carolina · Updated on 2026-01-07
12
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether a personalized brain stimulation method called repetitive transcranial magnetic stimulation (rTMS), combined with walking exercises, is a practical and tolerable approach to help people with Parkinson's disease who experience freezing of gait (FOG). FOG is a disabling symptom where people temporarily feel stuck and unable to start walking, even though they want to move. The main questions this study aims to answer are: Can people with Parkinson's disease and FOG tolerate this combined rTMS and walking training procedure? Can researchers successfully enroll and retain participants for this multi-visit intervention? Does the combination of rTMS and gait training show early signs of improving gait and reducing freezing episodes? This study does not include a comparison or placebo group. All participants will receive the same intervention. Participants will: Attend up to 15 study visits over about 16 weeks, with the option to combine visits to reduce burden. Complete brain imaging (MRI) before and after the intervention to guide and evaluate treatment. Receive a form of brain stimulation (rTMS) using a safe, non-invasive coil placed over a specific part of the brain called the supplementary motor area (SMA). The target is personalized using each person's MRI data. Participate in walking exercises that include cognitive tasks (dual-task gait training) after each set of brain stimulation sessions. Undergo assessments of walking ability, Parkinson's disease symptoms, and brain response to stimulation. Be videotaped during walking tasks to assess gait changes, while wearing small motion sensors on the body. Complete questionnaires about symptoms, safety, and tolerability. This study is being conducted at the Medical University of South Carolina (MUSC) and includes up to 15 adults between the ages of 50 and 80 who have been diagnosed with Parkinson's disease and experience FOG. Although rTMS is already FDA-cleared for depression and other conditions, it has not been approved for freezing of gait, and its use in this study is considered investigational. The stimulation device used has been determined to be non-significant risk (NSR) by the FDA. The study does not offer direct medical benefit to participants, but results from this trial may help researchers develop future treatments and better understand how brain stimulation affects walking difficulties in Parkinson's disease. Participation is voluntary, and individuals can withdraw from the study at any time without affecting their medical care
CONDITIONS
Official Title
Accelerated TMS for Freezing of Gait in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years
- Diagnosed with Parkinson's disease based on UK Brain Bank criteria
- Experience freezing of gait confirmed by a positive score on the nFOGQ within the last month
- No changes in dopaminergic medication in the past month
- Observed freezing of gait rated above 1 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale item 3.11
You will not qualify if you...
- History of significant walking difficulties unrelated to Parkinson's disease (e.g., orthopedic deformities)
- Unable to complete walking assessments without help or assistive devices
- Presence of barriers preventing contact between the TMS coil and the skin (e.g., unremovable braids)
- Do not meet MRI/TMS safety criteria, including claustrophobia, implanted electronic devices, metallic objects, or non-removable hair accessories
- Diagnosed with psychosis or cognitive impairments affecting understanding or consent
- Pregnant
- History of seizures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University of South Carlina
Charleston, South Carolina, United States, 29414
Actively Recruiting
Research Team
N
Niloufar Malakouti, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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