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

NCT07653256 | Not Yet Recruiting

• 1 other identifier: CS2-26021
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson's Disease; Corticomotor Excitability; Balance Control; Gait Performance; Motor Symptoms

Outcome Measures

Primary Outcomes (4)

• Corticospinal inhibition : Cortical silent period (CSP) (ms)

  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) (%)

  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)

  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)

  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 Outcomes (3)

• Gait speed (m/s) measured by GAITRite

  Baseline, week 5 and follow-up 1 month

• Step length (m) measured by GAITRite

  Baseline, week 5 and follow-up 1 month

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part III: Motor Examination (MDS-UPDRS-III)

  Baseline, week 5 and follow-up 1 month

Study Arms (2)

High-frequency rTMS + balance training

EXPERIMENTAL

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

Sham rTMS + balance training

SHAM COMPARATOR

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

Interventions

high-frequency repetitive transcranial magnetic stimulation DEVICE

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.

High-frequency rTMS + balance training

Sham rTMS DEVICE

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.

Sham rTMS + balance training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

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: February 25, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-02