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

NCT07190235 | Not Yet Recruiting DMC

• 1 other identifier: HSEARS20250512001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

transcranial magnetic stimulation; Parkinson's disease; supplementary motor area; gait

Outcome Measures

Primary Outcomes (1)

• Change in duration of anticipatory postural adjustments (APAs) during gait initiation

  The duration of APAs will be calculated from the center of pressure displacement trajectory, recorded by a force plate and Vicon motion capture system.

  Baseline, 2 weeks (post-intervention)

Secondary Outcomes (12)

• Change in duration of anticipatory postural adjustments (APAs) during gait initiation

  Baseline and 6 weeks (4-week post-intervention)

• Change in comfortable walking speed of the 10-meter walk test

  Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)

• Change in fast walking speed of the 10-meter walk test

  Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)

• Changes in Timed Up-and-Go Test (TUG)

  Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)

• Change in Unified Parkinson's Disease Rating Scale-motor examination (UPDRS-III)

  Baseline, 2 weeks (post-intervention), 6 weeks (4-week post-intervention)

Study Arms (3)

25 Hz repetitive transcranial magnetic stimulation group

EXPERIMENTAL

High-frequency repetitive transcranial magnetic stimulation (25 Hz), intended to increase cortical excitability and provide facilitatory neuromodulation.

Device: Transcranial Magnetic Stimulation

1 Hz repetitive transcranial magnetic stimulation group

EXPERIMENTAL

Low-frequency repetitive transcranial magnetic stimulation (1 Hz), intended to decrease cortical excitability and provide inhibitory neuromodulation.

Device: Transcranial Magnetic Stimulation

Sham stimulation group

PLACEBO COMPARATOR

The stimulation coil is positioned identically to active TMS and emits similar auditory and scalp sensations, but delivers no significant magnetic pulse to the brain, mimicking the active intervention experience without neuromodulatory effects.

Device: Transcranial Magnetic Stimulation Sham

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

1 Hz repetitive transcranial magnetic stimulation group; 25 Hz repetitive transcranial magnetic stimulation group

Transcranial Magnetic Stimulation Sham DEVICE

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.

Sham stimulation group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with PD according to thecriteria set by Movement Disorder Committee,
• with Hoehn and Yahr stages II-III, which are recognized as representing mild to moderate disease severity,
• have self-reported difficulty in gait initiation, assessed by item 5 of the freezing of gait questionnaire (FOGQ),
• have used a dopaminergic medication dose in the last month,
• a minimum score of 23 of 30 points on the Montreal Cognitive Assessment (MoCA).

You may not qualify if:

• patients with unstable medical conditions,
• unable to provide informed consent,
• other neurological conditions including stroke,
• contraindications for TMS,
• experienced deep brain stimulation treatment,
• no recordable motor evoked potentials (MEPs) with TMS.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, 000000, Hong Kong

Location

Related Publications (6)

• Rahimpour S, Rajkumar S, Hallett M. The Supplementary Motor Complex in Parkinson's Disease. J Mov Disord. 2022 Jan;15(1):21-32. doi: 10.14802/jmd.21075. Epub 2021 Nov 25.

  PMID: 34814237 BACKGROUND

• Mi TM, Garg S, Ba F, Liu AP, Wu T, Gao LL, Dan XJ, Chan P, McKeown MJ. High-frequency rTMS over the supplementary motor area improves freezing of gait in Parkinson's disease: a randomized controlled trial. Parkinsonism Relat Disord. 2019 Nov;68:85-90. doi: 10.1016/j.parkreldis.2019.10.009. Epub 2019 Oct 11.

  PMID: 31689588 BACKGROUND

• Jacobs JV, Lou JS, Kraakevik JA, Horak FB. The supplementary motor area contributes to the timing of the anticipatory postural adjustment during step initiation in participants with and without Parkinson's disease. Neuroscience. 2009 Dec 1;164(2):877-85. doi: 10.1016/j.neuroscience.2009.08.002. Epub 2009 Aug 7.

  PMID: 19665521 BACKGROUND

• Delval A, Tard C, Defebvre L. Why we should study gait initiation in Parkinson's disease. Neurophysiol Clin. 2014 Jan;44(1):69-76. doi: 10.1016/j.neucli.2013.10.127. Epub 2013 Oct 30.

  PMID: 24502907 BACKGROUND

• Chen Y, Jiang H, Wei Y, Ye S, Jiang J, Mak MKY, Pang MYC, Gao Q, Huang M. Effects of non-invasive brain stimulation over the supplementary motor area on motor function in Parkinson's disease: A systematic review and meta-analysis. Brain Stimul. 2025 Jan-Feb;18(1):1-14. doi: 10.1016/j.brs.2024.12.005. Epub 2024 Dec 11.

  PMID: 39667490 BACKGROUND

• Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.

  PMID: 32044947 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Meizhen Huang, PhD

CONTACT

+852 27664676; mei-zhen.huang@polyu.edu.hk

Yawen Chen, BSc

CONTACT

ya-wen.chen@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-06

Locations

HK (1)