Neuromodulation With rTMS in Dysphagic Patients With Stroke
1 other identifier
interventional
5
0 countries
N/A
Brief Summary
The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional outcome swallowing scale (3 scales). 3. MEP measurements
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
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
Study Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedJune 20, 2017
July 1, 2016
1 year
August 26, 2016
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
functional outcome
points of Australian Therapy Outcome Measures-the Swallowing scale as assessed by a clinical therapist
prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Secondary Outcomes (2)
videofluoroscopy
prior to treatment (baseline), on the next day after the 2 weeks treatment completion
cricopharyngeal motor evoked potentials
prior to treatment (baseline), on the next day after the 2 weeks treatment completion
Study Arms (2)
Real stimulation
EXPERIMENTALReal repetitive transcranial magnetic stimulation + swallowing training
Sham stimulation
SHAM COMPARATORSham repetitive transcranial magnetic stimulation + swallowing training
Interventions
Eligibility Criteria
You may qualify if:
- a diagnosis of stroke related dysphagia
- no concurrent neurodegenerative or dementia history
- an absence of TMS contraindications.
You may not qualify if:
- arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Rofes L, Vilardell N, Clave P. Post-stroke dysphagia: progress at last. Neurogastroenterol Motil. 2013 Apr;25(4):278-82. doi: 10.1111/nmo.12112. Epub 2013 Mar 11.
PMID: 23480388BACKGROUNDPark JW, Oh JC, Lee JW, Yeo JS, Ryu KH. The effect of 5Hz high-frequency rTMS over contralesional pharyngeal motor cortex in post-stroke oropharyngeal dysphagia: a randomized controlled study. Neurogastroenterol Motil. 2013 Apr;25(4):324-e250. doi: 10.1111/nmo.12063. Epub 2012 Dec 23.
PMID: 23279198BACKGROUNDLin WS, Chou CL, Chang MH, Chung YM, Lin FG, Tsai PY. Vagus nerve magnetic modulation facilitates dysphagia recovery in patients with stroke involving the brainstem - A proof of concept study. Brain Stimul. 2018 Mar-Apr;11(2):264-270. doi: 10.1016/j.brs.2017.10.021. Epub 2017 Nov 7.
PMID: 29162502DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Po-Yi Tsai
Department of Physical Medicine and Rehabilitation, Taipei Veterans General Hospital, Taipei, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
September 8, 2016
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
June 20, 2017
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share