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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a personalized brain stimulation method, combined with walking exercises, can help people with Parkinson's disease who experience freezing of gait (FOG). FOG occurs when someone feels stuck and cannot start walking, even if they want to. Participants will receive brain stimulation through repetitive transcranial magnetic stimulation (rTMS) and engage in walking exercises to determine if this approach can reduce freezing episodes. The trial seeks individuals diagnosed with Parkinson's disease who frequently experience FOG. While the study does not guarantee direct benefits to participants, it may assist researchers in developing future treatments for walking difficulties in Parkinson's disease. As an unphased trial, participants can contribute to pioneering research that may lead to innovative solutions for FOG.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that there should be no changes in dopaminergic medications (medications that affect dopamine levels) in the month before joining the study.

What prior data suggests that this method is safe for people with Parkinson's disease?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people with Parkinson's disease. In past studies, 4% of participants experienced a negative reaction, and no seizures occurred. Some participants reported temporary side effects, typically minor but not detailed.

The FDA has approved rTMS for treating conditions like depression. While it has shown potential in alleviating Parkinson's symptoms, its use for issues like freezing of gait remains under study. More research is needed to fully understand its effects in this area.

Overall, patients generally tolerate rTMS well, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard Parkinson's treatments that primarily focus on managing symptoms with medication like levodopa, this new approach combines transcranial magnetic stimulation (TMS) with gait training. TMS offers a non-invasive way to stimulate specific brain areas, potentially enhancing neuroplasticity and improving motor functions. The unique aspect here is the use of continuous theta burst stimulation (cTBS) targeted to a specific brain region, which could lead to faster and more effective improvements in movement and balance. Researchers are excited because this method could offer a novel way to enhance mobility and cognitive-motor integration in Parkinson's patients, potentially leading to better quality of life.

What evidence suggests that this TMS and gait training approach is effective for Parkinson's disease?

Research has shown that transcranial magnetic stimulation (TMS) can improve movement problems in people with Parkinson's disease. One study found that a specific type of TMS, called continuous theta burst stimulation (cTBS), eased movement issues and slowed disease progression. TMS has also boosted thinking abilities in Parkinson's patients, with some benefits lasting over time. This trial will investigate the effects of TMS combined with walking exercises on reducing freezing of gait (FOG), a common problem in Parkinson's. Although TMS is not yet approved specifically for FOG, these early results are promising for improving walking difficulties in Parkinson's disease. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9845788/

Comparative efficacy of transcranial magnetic stimulation on ... The pair-wise meta-analysis results showed that TMS could significantly improve motor symptoms in PD patients. Network meta-analysis results showed that the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1353802025006388

Effect of periodical continuous theta burst stimulation in ... This study showed that multiple cTBS can effectively relieve the motor symptoms of PD and delay the aggravation of the disease and the increase of anti- ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1354864/full

Effect of different modalities of transcranial magnetic ... TMS has some long-term sustained effects on improving cognitive function in Parkinson's patients. HF-rTMS is more effective in improving cognitive function in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11668114/

Repetitive transcranial magnetic stimulation improves ... Meta-analysis showed that transcranial magnetic stimulation significantly improved cognitive function in patients with Parkinson's disease after ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00319-4/fulltext

Efficacy of repetitive transcranial magnetic stimulation in ... The results suggest that high-frequency of rTMS on primary motor cortex (M1) is effective in improving motor symptoms; while the dorsolateral ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3653978/

Safety of Transcranial Magnetic Stimulation in Parkinson's ... Risk of an adverse event from rTMS was 0.040 (95% CI: 0.029 – 0.053) per patient and no seizures were reported. Other adverse events included transient ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00977184

50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) ... To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz rTMS (repetitive transcranial magnetic stimulation) and its safety in ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245709000418

Safety study of 50 Hz repetitive transcranial magnetic ... Fifty Hertz rTMS at an intensity of 90% RMT for 2 s appears safe in patients with PD, but caution should be taken for patients with paroxysmal EEG activity. For ...