HF-rTMS Primed Balance Training on Corticomotor Excitability, Balance, and Gait in Parkinson's

June 11, 2026 updated by: Chung Shan Medical University

Effects of High-frequency Repetitive Transcranial Magnetic Stimulation-primed Balance Training on Corticomotor Excitability, Balance, and Gait Performance in Parkinson's Disease

This study aims to investigate the effects of repeated transcranial magnetic stimulation combined with modified otago exercise program balance training intervention on motor cortex excitability, balance, and gait performance in patients with Parkinson's disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study plans to recruit 20 patients with Parkinson's disease. The experimental design is a double-blinded, randomized controlled trial, where neither the participants nor the evaluators will know the group assignments. All participants will receive rTMS "activation" followed by a modified Otago exercise program (balance training) specifically targeting Parkinson's disease. The intervention will last for 5 weeks, with sessions twice a week, totaling 10 treatments.

Before the intervention, participants will be randomly and evenly assigned to two groups: a high-frequency stimulation group (HF-rTMS) and a sham control group. This study will use the "Magstim Rapid² TMS system" for repetitive transcranial magnetic stimulation provided by the Department of Rehabilitation at Chung Shan Medical University Hospital.

For the sham control group, based on recommendations from previous related studies, participants will receive the same stimulation intensity as the experimental group, but the treatment coil will be placed on the head rotated by 90°, minimizing possible neurophysiological responses. This approach ensures a safe and humane experimental design.

Additionally, assessments will be conducted before the intervention, after all treatment sessions are completed, and at a one-month follow-up.

After completing the pre-test, the subjects will be randomly assigned to receive either high-frequency or sham rTMS treatment. The stimulation site is based on several recent systematic reviews and meta-analyses investigating the effects of repetitive transcranial magnetic stimulation on motor symptoms of Parkinson's disease (Conte D et al., 2025; Yang et al., 2018; Li et al., 2022), targeting the bilateral primary motor cortex for the lower limbs (M1-LL). The treatment lasts approximately 25 minutes. Immediately after the magnetic stimulation treatment, a 60-minute modified Otago exercise program (balance training) will be conducted. The balance training will be guided by a professional physical therapist.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with idiopathic PD
  • Aged between 40-80 years
  • Stable on antiparkinsonian medication ( > 3 months)
  • H&Y I-III
  • Able to walk continuously for at least 10 minutes
  • The ability to follow commands and instructions

Exclusion Criteria:

  • Neurological diseases other than PD
  • Severe musculoskeletal, cardiopulmonary disorders
  • MMSE < 24
  • Contraindications for TMS
  • Have undergone or are scheduled to undergo neurological surgery during the study participation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-frequency rTMS + balance training
Frequency: 10 Hz; Intensity: 90% RMT; Duration: 4 seconds; Rest time: 26 seconds; Sets: 25; Number of pulses: 1000*2; Total time: 25 minutes Followed by an improved Otago exercise program (60 minutes)
Device: high-frequency repetitive transcranial magnetic stimulation
A painless, non-invasive, and well-tolerated non-pharmacological treatment method-Repetitive Transcranial Magnetic Stimulation (rTMS)-delivers repeated and systematic magnetic field stimulation to specific brain regions through a stimulation coil placed on the scalp. These repeated magnetic pulses not only alter the excitability of the targeted area but also affect anatomically connected brain regions. The parameters are as follows: Frequency: 10 Hz; Intensity: 90% RMT; Duration: 4 seconds; Rest: 26 seconds; Trains: 25 times; Pulses: 1000*2; Total time: 25 minutes.
Sham Comparator: Sham rTMS + balance training

The stimulation parameters were the same as those of the experimental group, with only the stimulation coil rotated 90° to minimize the neurophysiological effects.

Followed by an improved Otago exercise program (60 minutes)
Device: Sham rTMS
In this study, the sham stimulation group was designed based on previous related research and expert recommendations. Participants in this group will receive 20% of the stimulation intensity used in the treatment group, which is significantly lower than the treatment group's 90%, ensuring a safe and humane experimental design. The parameters are as follows: Frequency: 10 Hz; Intensity: 20% RMT; Duration: 4 seconds; Rest: 26 seconds; Trains: 25 times; Pulses: 1000*2; Total time: 25 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corticospinal inhibition : Cortical silent period (CSP) (ms)
Time Frame: Baseline, week 5 and follow-up 1 month
Cortical silent period (CSP) measured by Transcranial Magnetic Stimulation (TMS), with higher ms indicating stronger corticospinal inhibitory effect
Baseline, week 5 and follow-up 1 month
Intracortical inhibition : Short-interval intracortical inhibition (SICI) (%)
Time Frame: Baseline, week 5 and follow-up 1 month
Short-interval intracortical inhibition (SICI) measured by Transcranial Magnetic Stimulation (TMS), with higher percentage indicating stronger intracortical inhibitory effect
Baseline, week 5 and follow-up 1 month
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Baseline, week 5 and follow-up 1 month
Mini-Balance Evaluation Systems Test (Mini-BESTest) is used to assess balance performance. Total scores range from 0 to 28, with higher scores indicating better balance and functional mobility.
Baseline, week 5 and follow-up 1 month
Falls Efficacy Scale-International (FES-I)
Time Frame: Baseline, week 5 and follow-up 1 month
Falls Efficacy Scale-International (FES-I) is used to assess confidence in balance. Total scores range from 16 to 64, with higher scores indicating more balanced confidence
Baseline, week 5 and follow-up 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed (m/s) measured by GAITRite
Time Frame: Baseline, week 5 and follow-up 1 month
Baseline, week 5 and follow-up 1 month
Step length (m) measured by GAITRite
Time Frame: Baseline, week 5 and follow-up 1 month
Baseline, week 5 and follow-up 1 month
Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part III: Motor Examination (MDS-UPDRS-III)
Time Frame: Baseline, week 5 and follow-up 1 month
MDS-UPDRS-III is used to assess motor symptoms in patients with Parkinson's disease. Total scores range from 0 to 132, with higher scores indicating more severe motor symptoms.
Baseline, week 5 and follow-up 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS2-26021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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