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rTMS in Chronic Poststroke Dysphagia

NCT05590819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-02-02

No results posted yet for this study

Summary

The goal of this study is to investigate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS) applying on suprahyoid motor cortex in chronic poststroke dysphagia, and its effect on hyolaryngeal movement.

Participants will be randomized into three groups. The three experimental groups received either bilateral or ipsilateral rTMS, or iTBS (with contralateral sham stimulation) at suprahyoid motor cortex, while the placebo group received bilateral sham stimulation. Stimulation will be given at 5 hertz(Hz), 1000 pulses of rTMS or 600 pulses of iTBS per session, for a total of 10 sessions. The swallowing function, penetration-aspiration scale of video-fluoroscopic swallowing study, motor evoked potential of suprahyoid muscles, intraoral pressure, and ultrasound swallowing exam will be evaluated before therapy, and at 1, 3, 6 months post therapy.

Conditions

  • Deglutition Disorders

Interventions

DEVICE

repetitive transcranial magnetic stimulation(rTMS)

5 hertz(Hz), 1000 pulses, 90% RMT stimulation; 15 minutes per session; for a total of 10 sessions

DEVICE

Intermittent Theta-burst Stimulation(iTBS)

3 pulses of stimulation delivered at 50 Hz and repeated at 5 Hz; 2s train of TBS with repetitive interval of every 10s, 70% RMT; 600 pulses in total; 15 minutes per session; for a total of 10 sessions

DEVICE

Sham stimulation

Set-up the coil without true stimulation; 15 minutes per session; for a total of 10 sessions

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ming-Yen Hsiao, PHD · Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-05
Primary Completion
2024-05-01
Completion
2024-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590819 on ClinicalTrials.gov