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

Official title

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

Overview

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.

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.

Interventions

• 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
• 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.

Primary outcome measures

• Corticospinal inhibition : Cortical silent period (CSP) (ms) [Time frame: 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]
• Mini-Balance Evaluation Systems Test (Mini-BESTest) [Time frame: Baseline, week 5 and follow-up 1 month]
• Falls Efficacy Scale-International (FES-I) [Time frame: Baseline, week 5 and follow-up 1 month]

Secondary outcome measures (3)

• Gait speed (m/s) measured by GAITRite [Time frame: Baseline, week 5 and follow-up 1 month]
• Step length (m) measured by GAITRite [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07653256 · CS2-26021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗