Accelerated TMS for Freezing of Gait in Parkinson's Disease

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06982638
Status
Recruiting
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Conditions

  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS+ Gait training — DEVICE
    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.

Study Details

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

Key Dates

Start date
Nov 21, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: TMS+Gait training
    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.

Primary Outcome Measure

Tolerability of the Intervention [ Time Frame: Immediately after each TMS session during the 6 treatment days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarlinaCharlestonSouth Carolina29414
Niloufar Malakouti, MD, MSc
[email protected]
843-792-0235
Gonzalo Revuelta, DO (PRINCIPAL_INVESTIGATOR)

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Medical University of South Carlina· Charleston, SC

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