TMS + Gait Training for Parkinson's Disease

(TMS Trial)

Overseen By Niloufar Malakouti, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Gait impairment, Psychosis, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults aged 50-80 with Parkinson's disease who experience freezing of gait. They must be able to attend up to 15 visits over 16 weeks at MUSC, complete MRI scans, and participate in walking exercises combined with cognitive tasks.

Inclusion Criteria

I haven't changed my Parkinson's medication in the last month.

I have experienced freezing of gait in the last month.

Diagnosis of PD based on UK Brain Bank diagnostic criteria

Exclusion Criteria

Diagnosis of psychosis or any other cognitive impairments affecting understanding or ability to consent

Pregnancy

I have had a seizure before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized, accelerated course of continuous theta burst stimulation (cTBS) over the supplementary motor area (SMA), combined with dual-task gait training.

2 weeks

6 treatment visits, 8 rTMS sessions per day

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of gait and Parkinson's symptoms.

3 months

5 follow-up assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• TMS

Trial Overview The study tests a personalized brain stimulation method (rTMS) paired with walking exercises on people with Parkinson's disease and freezing of gait. It aims to see if this combination can improve their ability to walk and reduce freezing episodes without using a comparison group.

Participant Groups

Group I: TMS+Gait training Experimental Treatment 1 Intervention

Participants in this single-arm study will receive a personalized, accelerated course of continuous theta burst stimulation (cTBS) over a functionally defined subregion of the supplementary motor area (SMA), which is individually targeted using resting-state functional MRI. The stimulation will be delivered using a MagPro Cool-B65 A/P figure-of-eight coil at 110% of resting motor threshold. Each participant will undergo 6 treatment visits over 2 weeks , receiving 8 rTMS sessions per day (600 pulses/session), totaling 28,800 pulses across the study. TMS sessions will be interleaved with dual-task gait training involving cognitive walking exercises. Gait training will be conducted for 30 minutes per visit, immediately following stimulation blocks. Safety, tolerability, adherence, gait performance, and neuroplasticity will be evaluated pre- and post-intervention using clinical scales, motor evoked potentials (MEPs), and functional MRI.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+