Back to resultsFunctional Neuroimage in Assessment of Post-stroke Aphasia
Primary Purpose
Stroke, Aphasia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, aphasia, rTMS, Functional MRI, Speech training
Eligibility Criteria
Inclusion Criteria:
- Aphasic stroke in chronic stage (over 3 months)
Exclusion Criteria:
- No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1 Hz rTMS, real
1Hz rTMS, sham
Arm Description
1 Hz rTMS over unaffected hemisphere for 15 minutes
1Hz sham rTMS, over unaffected hemisphere for 15 minutes
Outcomes
Primary Outcome Measures
Concise Chinese Aphasia Test
Assess the linguistic skills such as conversation, expression, description, comprehension...
Secondary Outcome Measures
Functional MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02120508
Brief Title
Functional Neuroimage in Assessment of Post-stroke Aphasia
Official Title
Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
vghtpe user
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
stroke, aphasia, rTMS, Functional MRI, Speech training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Hz rTMS, real
Arm Type
Experimental
Arm Description
1 Hz rTMS over unaffected hemisphere for 15 minutes
Arm Title
1Hz rTMS, sham
Arm Type
Sham Comparator
Arm Description
1Hz sham rTMS, over unaffected hemisphere for 15 minutes
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
Magstim, Rapid2
Intervention Description
To test the efficacy of this specific setting.
Primary Outcome Measure Information:
Title
Concise Chinese Aphasia Test
Description
Assess the linguistic skills such as conversation, expression, description, comprehension...
Time Frame
Before the rTMS intervention, at 2nd week, and 3rd month
Secondary Outcome Measure Information:
Title
Functional MRI
Time Frame
Before rTMS intervention, and at the day completing the rTMS treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aphasic stroke in chronic stage (over 3 months)
Exclusion Criteria:
No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Yi Tsai, MD
Phone
886-228757293
Email
pytsai@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Organizational Affiliation
Department of physical medicine and rehabilitation, Taipei Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Phone
886-228757293
12. IPD Sharing Statement
Citations:
PubMed Identifier
24526709
Citation
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.
Results Reference
background
PubMed Identifier
25378426
Citation
Wang 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.
Results Reference
derived
Learn more about this trial
Functional Neuroimage in Assessment of Post-stroke Aphasia
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