rTMS in Aphasic Patients With Neuroimage Assessments
Synchronous rTMS and Computer-integrated Speech Training Applied in Aphasic Patients
1 other identifier
interventional
120
1 country
1
Brief Summary
The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its merit in terms of learning programs as a treatment for aftereffect augmentation. Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Feb 2017
Longer than P75 for not_applicable stroke
1 active site
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
January 16, 2017
CompletedStudy Start
First participant enrolled
February 18, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2021
CompletedJanuary 8, 2021
January 1, 2021
4.8 years
January 16, 2017
January 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks
linguistic function assessment
Up to 12 weeks
Secondary Outcomes (1)
Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks
Up to 12 weeks
Study Arms (3)
Experimental
EXPERIMENTALrepetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.
Sham stimulation
SHAM COMPARATORSham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.
High frequency rTMS
EXPERIMENTALHigh-frequency rTMS to ipsilesional region for 10 daily sessions.
Interventions
undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions
Eligibility Criteria
You may qualify if:
- Aphasic stroke in chronic stage (over 3 months)
You may not qualify if:
- No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, Taiwan
Related Publications (3)
Tsai PY, Wang CP, Ko JS, Chung YM, Chang YW, Wang JX. The persistent and broadly modulating effect of inhibitory rTMS in nonfluent aphasic patients: a sham-controlled, double-blind study. Neurorehabil Neural Repair. 2014 Oct;28(8):779-87. doi: 10.1177/1545968314522710. Epub 2014 Feb 13.
PMID: 24526709BACKGROUNDChou TY, Wang JC, Lin MY, Tsai PY. Low-Frequency vs. Theta Burst Transcranial Magnetic Stimulation for the Treatment of Chronic Non-fluent Aphasia in Stroke: A Proof-of-Concept Study. Front Aging Neurosci. 2022 Jan 14;13:800377. doi: 10.3389/fnagi.2021.800377. eCollection 2021.
PMID: 35095477DERIVEDLee IT, Huang CC, Hsu PC, Lin CP, Tsai PY. Resting-State Network Changes Following Transcranial Magnetic Stimulation in Patients With Aphasia-A Randomized Controlled Study. Neuromodulation. 2022 Jun;25(4):528-537. doi: 10.1016/j.neurom.2021.10.004. Epub 2021 Dec 18.
PMID: 35088736DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Po-Yi Tsai, MD
Department of physical medicine and rehabilitation, Taipei Veterans General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 16, 2017
First Posted
February 23, 2017
Study Start
February 18, 2017
Primary Completion
December 23, 2021
Study Completion
December 23, 2021
Last Updated
January 8, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share