NCT07190235

The Effect of rTMS Over the SMA on Gait Performance in Parkinson's Disease

The Effect of Repetitive Transcranial Magnetic Stimulation Over the Supplementary Motor Area on Gait Performance in Parkinson's Disease: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effects of high-frequency and low-frequency repetitive transcranial magnetic stimulation (rTMS) over the supplementary motor area (SMA) on gait performance, especially gait initiation, in individuals with Parkinson's disease (PD). Furthermore, the investigators will explore the impact of rTMS over the SMA on walking speed, functional mobility, and limits of stability in PD. It is hypothesized that rTMS over the SMA will improve gait performance in PD.

Detailed description

The goal of this clinical trial is to investigate the effects of high-frequency and low-frequency rTMS over the SMA on gait performance, especially gait initiation, in individuals with PD. The primary outcome will be anticipatory postural adjustments (APAs) during gait initiation. The secondary outcome will include walking speed, the timed up-and-go test (TUG), and limits of stability. The hypotheses are: 1. Both 25 Hz and 1 Hz rTMS will have a significant effect on gait performance, especially the gait initiation phase, as assessed by APAs in PD, compared with sham stimulation. 2. 25 Hz and 1 Hz rTMS will have a different effect on gait initiation in PD. This study will be a three-arm, randomized, double-blind, placebo-controlled study examining the effect of 25 Hz or 1 Hz SMA-TMS compared with that observed after sham TMS. A total of 81 individuals with PD will be recruited and allocated into three different groups: 1 Hz TMS group, 25 Hz TMS group, and sham TMS group. Participants in each group will receive 10 TMS sessions over 2 weeks. Assessors will conduct evaluations at baseline, post-intervention, and 4-week post-intervention. The primary outcome will be APAs during gait initiation. The secondary outcome will include walking speed, TUG , and limits of stability.

Conditions

• PARKINSON DISEASE (Disorder)

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	The repetitive transcranial magnetic stimulation (rTMS) at different frequencies will deliver 10 sessions over 2 weeks. The participants will receive different stimulation protocols to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.
DEVICE	Transcranial Magnetic Stimulation Sham	The sham transcranial magnetic stimulation (TMS) will deliver 10 sessions over 2 weeks. The participants will receive the sham stimulation protocol to the supplementary motor area while seated using a double-cone coil connected to a transcranial magnetic stimulator.

Timeline

• Start date: 2026-01-06
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-09-24
• Last updated: 2026-01-02

Locations

1 site across 1 country: Hong Kong