rTMS in Chronic Poststroke Dysphagia
The Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Poststroke Dysphagia.
1 other identifier
interventional
150
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
February 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedFebruary 2, 2023
September 1, 2022
1.2 years
October 6, 2022
February 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
penetration-aspiration scale(PAS)
Penetration-aspiration scale will be calculated by videofluoroscopic swallow study with measurement of the depth of penetrated or aspirated material and the patient's response to airway invasion. Score range is 1 to 8; higher score means more severe on penetration and aspiration.
Day 30 (change of PAS, comparing with the data in baseline) of each section
penetration-aspiration scale(PAS)
Penetration-aspiration scale will be calculated by videofluoroscopic swallow study with measurement of the depth of penetrated or aspirated material and the patient's response to airway invasion. Score range is 1 to 8; higher score means more severe on penetration and aspiration.
Day 90 (change of PAS, comparing with the data in baseline and Day 30) of each section
Secondary Outcomes (6)
The Swallowing Quality-of-Life questionnaire(SWAL-QOL)
Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
The Functional Oral Intake Scale (FOIS)
Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
The Dysphagia Severity Scale (DSS)
Day 14, Day 30, Day 90, Day 180 (comparing with the data in baseline) of each section
Iowa Oral Performance Instrument (IOPI)
Baseline, Day 14, Day 30, Day 90, Day 180
Swallowing ultrasound
Baseline, Day 14, Day 30, Day 90, Day 180
- +1 more secondary outcomes
Study Arms (6)
bilateral rTMS
EXPERIMENTAL5 hertz(Hz), 1000 pulses, 90% resting motor threshold(RMT) stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes.
unilateral rTMS
EXPERIMENTAL5 hertz(Hz), 1000 pulses, 90% RMT stimulation on motor cortex of suprahyoid muscle at ipsilateral side as the lesion for 15 minutes; sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
control group of rTMS
PLACEBO COMPARATORSham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
bilateral iTBS
EXPERIMENTAL600 pulses iTBS stimulation on bilateral motor cortex of suprahyoid muscle for 15 minutes.
unilateral iTBS
EXPERIMENTAL600 pulses iTBS on motor cortex of suprahyoid muscle at ipsilateral side as the lesion for 15 minutes; sham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
control group of iTBS
PLACEBO COMPARATORSham stimulation on motor cortex of suprahyoid muscle at contra-lateral side as the lesion for 15 minutes.
Interventions
5 hertz(Hz), 1000 pulses, 90% RMT stimulation; 15 minutes per session; for a total of 10 sessions
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
Set-up the coil without true stimulation; 15 minutes per session; for a total of 10 sessions
Eligibility Criteria
You may qualify if:
- age \> 20 years old, diagnosed of subcortical stroke(including ischemic or hemorrhagic type) by CT or MRI image study
- sustained the symptoms of dysphagia more than one month after stroke.
- Functional Oral Intake Scale (FOIS) between 1 to 5 score
- Maintenance on sitting balance over 15 minutes
You may not qualify if:
- Disturbed consciousness, unable to communicate and obey order through gesture or language
- Disease or trauma involved central neural system, such as Parkinson's disease, traumatic brain injury, brain tumor or multiple sclerosis
- Any disorder inducing dysphagia, such as nasopharyngeal cancer(NPC) or cervical cancer
- Metal Implants or pacemaker
- Global aphasia or cognitive impairment
- History of epilepsy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PMID: 19833552BACKGROUNDRao J, Li F, Zhong L, Wang J, Peng Y, Liu H, Wang P, Xu J. Bilateral Cerebellar Intermittent Theta Burst Stimulation Combined With Swallowing Speech Therapy for Dysphagia After Stroke: A Randomized, Double-Blind, Sham-Controlled, Clinical Trial. Neurorehabil Neural Repair. 2022 Jul;36(7):437-448. doi: 10.1177/15459683221092995. Epub 2022 May 16.
PMID: 35574927BACKGROUNDYu-Lei X, Shan W, Ju Y, Yu-Han X, Wu Q, Yin-Xu W. Theta burst stimulation versus high-frequency repetitive transcranial magnetic stimulation for poststroke dysphagia: A randomized, double-blind, controlled trial. Medicine (Baltimore). 2022 Jan 14;101(2):e28576. doi: 10.1097/MD.0000000000028576.
PMID: 35029231BACKGROUNDWen X, Liu Z, Zhong L, Peng Y, Wang J, Liu H, Gong X. The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Post-stroke Dysphagia: A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2022 Mar 17;16:841781. doi: 10.3389/fnhum.2022.841781. eCollection 2022.
PMID: 35370584BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ming-Yen Hsiao, PHD
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 21, 2022
Study Start
February 5, 2023
Primary Completion
May 1, 2024
Study Completion
August 31, 2024
Last Updated
February 2, 2023
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share