Functional Neuroimage in Assessment of Post-stroke Aphasia
Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
1 other identifier
interventional
60
1 country
1
Brief Summary
The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Aug 2012
Typical duration 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
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 22, 2014
April 1, 2014
3 years
April 18, 2014
April 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concise Chinese Aphasia Test
Assess the linguistic skills such as conversation, expression, description, comprehension...
Before the rTMS intervention, at 2nd week, and 3rd month
Secondary Outcomes (1)
Functional MRI
Before rTMS intervention, and at the day completing the rTMS treatment.
Study Arms (2)
1 Hz rTMS, real
EXPERIMENTAL1 Hz rTMS over unaffected hemisphere for 15 minutes
1Hz rTMS, sham
SHAM COMPARATOR1Hz sham rTMS, over unaffected hemisphere for 15 minutes
Interventions
To test the efficacy of this specific setting.
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
- vghtpe userlead
Study Sites (1)
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Publications (2)
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: 24526709BACKGROUNDWang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.
PMID: 25378426DERIVED
MeSH Terms
Conditions
Condition 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, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Po-Yi Tsai, MD
Study Record Dates
First Submitted
April 18, 2014
First Posted
April 22, 2014
Study Start
August 1, 2012
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
April 22, 2014
Record last verified: 2014-04