Actively Recruiting
Accelerated Transcranial Magnetic Stimulation Combined with Walking Exercises 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized brain stimulation method called repetitive transcranial magnetic stimulation (rTMS) combined with walking exercises to help people with Parkinson's disease who experience freezing of gait (FOG). FOG is a disabling symptom where a person temporarily feels stuck and unable to start walking. This study aims to find out if this combined approach is practical, tolerable, and shows early signs of improving walking and reducing freezing episodes in this group. Participants will receive a personalized, accelerated course of continuous theta burst stimulation (cTBS) targeting a specific brain area called the supplementary motor area (SMA), guided by each person's brain imaging (MRI). They will undergo 6 treatment visits over 2 weeks, each day receiving 8 rTMS sessions. After each stimulation block, participants will do 30 minutes of walking exercises that include cognitive tasks. Researchers will evaluate safety, tolerability, adherence, walking performance, and brain changes using clinical scales, motor responses, and MRI before and after the intervention. Participants will attend up to 15 study visits over about 16 weeks, including brain imaging before and after treatment. They will be assessed on walking ability, Parkinson's symptoms, and brain response to stimulation. Walking will be videotaped with motion sensors for detailed analysis. Questionnaires on symptoms, safety, and tolerability will also be completed. The study monitors tolerability immediately after each stimulation session and adherence throughout the total study period to understand the intervention's impact and feasibility.
CONDITIONS
Brief Title
Accelerated TMS for Freezing of Gait in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 to 80 years
- Diagnosed with Parkinson's disease based on UK Brain Bank criteria
- Experiencing freezing of gait confirmed by questionnaire and clinical observation
- No changes in dopaminergic medication in the past month
- Able to participate in gait assessments without assistance
You will not qualify if you...
- History of significant gait problems unrelated to Parkinson's disease
- Unable to complete gait assessments without assistance or devices
- Barriers preventing contact between TMS coil and scalp (e.g., unremovable braids)
- Failing MRI/TMS safety screening due to claustrophobia, implanted devices, metal fragments, or non-removable piercings
- Diagnosis of psychosis or cognitive impairments affecting consent or study participation
- Pregnancy
- History of seizures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive a personalized, accelerated course of continuous theta burst stimulation (cTBS) over a functionally defined subregion of the supplementary motor area (SMA), combined with dual-task gait training involving cognitive walking exercises immediately following stimulation blocks.
6 treatment visits over 2 weeks, with 8 TMS sessions per day and 30 minutes of gait training per visit
Duration - Up to 14 weeks
Participants are assessed for safety, tolerability, adherence, gait performance, and neuroplasticity using clinical scales, motor evoked potentials (MEPs), and functional MRI after the intervention ends.
Follow-up assessments at baseline, immediately after intervention, and at 1, 2, and 3 months post-intervention
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
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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