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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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