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

11. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)
Enhet: 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-komparator: 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)
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Corticospinal inhibition : Cortical silent period (CSP) (ms)
Tidsramme: 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) (%)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gait speed (m/s) measured by GAITRite
Tidsramme: Baseline, week 5 and follow-up 1 month
Baseline, week 5 and follow-up 1 month
Step length (m) measured by GAITRite
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chung Shan Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

25. februar 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CS2-26021

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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Kliniske studier på high-frequency repetitive transcranial magnetic stimulation

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