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PARKINSON DISEASE (Disorder)NCT07190235

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

A study testing Transcranial Magnetic Stimulation in people with PARKINSON DISEASE (Disorder), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
PARKINSON DISEASE (Disorder)
What is being tested?
Transcranial Magnetic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
1 siteHong Kong
Study dates
6 Jan 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meizhen Huang, PhD contact

+852 27664676

mei-zhen.huang@polyu.edu.hk

Yawen Chen, BSc contact

ya-wen.chen@connect.polyu.hk

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Kowloon, 000000

    Yawen Chen, BSc, +852 27664676, ya-wen.chen@connect.polyu.hk

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Being tested
Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation Sham
Keywords
transcranial magnetic stimulation, Parkinson's disease, supplementary motor area, gait
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic StimulationDevice

    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.

  • Transcranial Magnetic Stimulation ShamDevice

    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.

Study groups in NCT07190235
Study groupRoleWhat they receive
25 Hz repetitive transcranial magnetic stimulation groupExperimentalHigh-frequency repetitive transcranial magnetic stimulation (25 Hz), intended to increase cortical excitability and provide facilitatory neuromodulation.
Receives: Device: Transcranial Magnetic Stimulation
1 Hz repetitive transcranial magnetic stimulation groupExperimentalLow-frequency repetitive transcranial magnetic stimulation (1 Hz), intended to decrease cortical excitability and provide inhibitory neuromodulation.
Receives: Device: Transcranial Magnetic Stimulation
Sham stimulation groupPlacebo comparatorThe 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.
Receives: Device: Transcranial Magnetic Stimulation Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 2 weeks (post-intervention)

Secondary outcomes (12)

  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.

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

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

    Comfortable walking speed is a critical outcome due to its reliability, sensitivity to change, and clinical relevance in reflecting functional mobility and disease progression. This study will use 10-meter walk test to measure the walking speed.

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

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

    Fast gait speed was assessed by taking an average of three trials of a 10-meter walk test (as fast as one can safely walk). Walking at high speeds poses a challenge for individuals with PD, as bradykinesia, while fast walking demands greater balance and postural stability. Fast gait speed has excellent test-retest reliability with an intraclass correlation coefficient (ICC) of 0.97 in individuals with PD.

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

  4. Changes in Timed Up-and-Go Test (TUG)

    The TUG is a reliable and valid test used to assess functional mobility and walking capacity in PD and requires the individual to stand up from a chair, walk seven meters, turn around, walk back to the chair, and sit down. The time taken to complete the task is recorded, with longer times indicating poorer mobility. It is commonly used in geriatric populations to evaluate fall risk and in individuals with various health conditions, including PD.

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

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

    UPDRS-III is used to assess motor symptoms in PD. It is a scale with 33 scores based on 18 questions with several right, left, or other body distribution scores. It evaluates motor symptoms such as tremor, rigidity, bradykinesia, postural instability, and gait. All items have 5 response options with uniform anchors of normal rated 0, slight rated 1, mild rated 2, moderate rated 3, and severe rated 4. Higher scores indicate greater impact of PD symptoms, providing a comprehensive overview of motor abilities and aiding in the monitoring of disease progression and treatment efficacy.

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

  6. Change in score of Mini-Balance Evaluation System Test (MiniBEST)

    The Mini-BEST is a clinical tool designed to assess balance in individuals with PD and other conditions. It evaluates dynamic balance, functional mobility, sensory organization, APAs, postural responses, and dynamic gait. The test consists of 14 items and is scored out of 28 points, with uniform anchors of normal rated 0, moderate rated 1, and severe rated 2.

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

  7. Change in freezing of gait questionnaire (FOGQ)

    The FOGQ is a self-report questionnaire specifically designed to evaluate the presence and severity of FOG in patients with PD. FOG is a phenomenon where patients temporarily feel as though their feet are glued to the floor, impeding their ability to walk. The FOGQ helps in quantifying the impact of FOG on daily living and can guide therapeutic interventions. This questionnaire comprised six questions (maximum score 24 points) that sought to assess both freezing of gait, as well as gait disturbance.

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

  8. Change in the 39-item Parkinson's disease questionnaire (PDQ-39)

    PDQ-39 is a widely used tool to assess the health-related quality of life in individuals with PD. It consists of 39 questions that cover various aspects of daily living, including mobility, emotional well-being, social support, and activities of daily living. The PDQ-39 is designed to capture both physical and psychological impacts of the disease, helping clinicians evaluate the extent to which Parkinson's disease affects a patient's quality of life.

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

  9. Change in resting motor threshold (RMT)

    The RMT is the minimum stimulus intensity that evokes responses of approximately 100 µV with a similar shape and latency in 5 out of 10 successive stimuli.

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

  10. Change in short-interval intracortical inhibition (SICI)

    SICI is the measure of the intracortical inhibition mediated by GABAA receptors.

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

  11. Intracortical facilitation (ICF)

    ICF is the measure of the intracortical facilitation mediated by glutamate receptors.

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

  12. Changes in the slope of the stimulus response curve (SRC)

    The Changes in the slope of the stimulus-response curve (SRC) as an outcome measure refer to how the steepness of the SRC varies, reflecting the rate at which the motor evoked potential (MEP) amplitude increases in response to increasing stimulus intensity.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start6 Jan 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190235
Sponsor's protocol ID
HSEARS20250512001
Status last verified
Jun 2025
First submitted
16 Sep 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34814237

  • 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.

    PubMed 31689588

  • 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.

    PubMed 19665521

  • 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.

    PubMed 24502907

  • 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.

    PubMed 39667490

  • 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.

    PubMed 32044947

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation in people with PARKINSON DISEASE (Disorder), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meizhen Huang, PhD (+852 27664676, mei-zhen.huang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in duration of anticipatory postural adjustments (APAs) during gait initiation (time frame: Baseline, 2 weeks (post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07190235, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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