NCT07195773

Brief Summary

This study aimed to investigate the effects of rTMS on balance performance and functional mobility in people with PD. Additionally, it further examines the effects of single-session low-frequency and high-frequency repetitive transcranial magnetic stimulation on balance performance and functional mobility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

December 16, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

May 7, 2024

Last Update Submit

February 25, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Dynamic balance

    Functional Reach Test

    FRT will be assessed before and immediately after each intervention. Each intervention is separated by a 2-week washout period. All assessments occur within an 4-week period.

  • Functional mobility

    Timed Up and Go test

    TUG will be assessed before and immediately after each intervention. Each intervention is separated by a 2-week washout period. All assessments occur within an 4-week period.

  • Motor function

    UPDRS-III

    UPDRS-III will be assessed before and immediately after each intervention. Each intervention is separated by a 2-week washout period. All assessments occur within an 4-week period.

Study Arms (3)

Group A

EXPERIMENTAL

Patients in this group first undergo high-frequency rTMS treatment, followed by a two-week rest period, then proceed to low-frequency rTMS after another two-week rest, and finally receive sham stimulation rTMS. rTMS high-frequency 1Hz 80%RMT rTMS low-frequency 1Hz 80%RMT rTMS sham 10HZ 20%RMT

Device: rTMS

Group B

EXPERIMENTAL

Patients in this group first undergo low-frequency rTMS treatment, followed by a two-week rest period, then proceed to high-frequency rTMS after another two-week rest, and finally receive sham stimulation rTMS. rTMS high-frequency 1Hz 80%RMT rTMS low-frequency 1Hz 80%RMT rTMS sham 10HZ 20%RMT

Device: rTMS

Group C

EXPERIMENTAL

Patients in this group first undergo sham stimulation rTMS treatment, followed by a two-week rest period, then proceed to high-frequency rTMS after another two-week rest, and finally receive low-frequency rTMS. rTMS high-frequency 1Hz 80%RMT rTMS low-frequency 1Hz 80%RMT rTMS sham 10HZ 20%RMT

Device: rTMS

Interventions

rTMSDEVICE

Participants will receive different stimulation approaches in sequences: high-frequency rTMS, low-frequency rTMS, and sham rTMS. They will be randomly assigned to three groups with different stimulation sequences. After each single stimulation, balance performance, functional mobility, and motor symptoms will be measured. In this study, eighteen PD patients with Hoehn and Yahr stage 1 to 3 will be recruited.

Group AGroup BGroup C

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with primary Parkinson's disease
  • Age: 40-85 years
  • Hoehn and Yahr scale (H\&Y scale) : I-III
  • Appropriate prescribed medication, and regular intake for more than 2 weeks
  • Can walk more than 10m with or without the use of assistive devices

You may not qualify if:

  • Any other neurological presentation (Excluding PD)
  • Any neurological surgery that would affect participation in this experiment
  • Orthopedic pathology and Cardiovascular issues
  • MMSE≦24
  • Exercise used for treatment in the last three months
  • Contraindications for transcranial magnetic stimulation (Presence of metal implants in the head and neck, a pacemaker in the chest, personal or family history of epilepsy, recent brain injury, currently taking antidepressant medication.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical Unirversity

Taichung, Southern District, 40201, Taiwan

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Skills Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurodevelopmental DisordersMental Disorders

Study Officials

  • LIU HSIN-HSUAN, PhD

    Assistant Professor

    STUDY CHAIR
  • HONG SONG-PING, BSc

    student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

September 29, 2025

Study Start

December 16, 2024

Primary Completion

November 19, 2025

Study Completion

November 19, 2025

Last Updated

February 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The purpose of the first study is to investigate the effects of repetitive transcranial magnetic stimulation on corticomotor excitability, balance performance, and mobility in patients with Parkinson's disease, and to further explore the effects on corticomotor excitability by single low-frequency and high-frequency repetitive transcranial magnetic stimulation. Participants will receive different stimulation approaches in sequences: high-frequency rTMS, low-frequency rTMS, and sham rTMS. They will be randomly assigned to three groups with different stimulation sequences. After each single stimulation, corticomotor excitability, balance, and motor symptoms will be measured. In this study, eighteen PD patients with Hoehn and Yahr stage 1 to 3 will be recruited.

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
5 years

Locations