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Functional Neuroimage in Assessment of Post-stroke Aphasia

Sponsor
vghtpe user (Other)
Overall Status
Unknown status
CT.gov ID
NCT02120508
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
38
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: rTMS
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Aug 1, 2015
Anticipated Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 Hz rTMS, real

1 Hz rTMS over unaffected hemisphere for 15 minutes

Device: rTMS
To test the efficacy of this specific setting.
Other Names:
  • Magstim, Rapid2

    		•
    Sham Comparator: 1Hz rTMS, sham

    1Hz sham rTMS, over unaffected hemisphere for 15 minutes

    Device: rTMS
    To test the efficacy of this specific setting.
    Other Names:
  • Magstim, Rapid2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concise Chinese Aphasia Test [Before the rTMS intervention, at 2nd week, and 3rd month]

      Assess the linguistic skills such as conversation, expression, description, comprehension...

    Secondary Outcome Measures

    1. Functional MRI [Before rTMS intervention, and at the day completing the rTMS treatment.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Veterans General Hospital Taipei Taiwan 11217

    Sponsors and Collaborators

    • vghtpe user

    Investigators

    • Principal Investigator: Po-Yi Tsai, MD, Department of physical medicine and rehabilitation, Taipei Veterans General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan
    ClinicalTrials.gov Identifier:
    NCT02120508
    Other Study ID Numbers:
    • 201207007AC
    First Posted:
    Apr 22, 2014
    Last Update Posted:
    Apr 22, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan
    stroke
    aphasia
    rTMS
    Functional MRI
    Speech training
    Additional relevant MeSH terms:
    Stroke
    Aphasia

    Study Results

    No Results Posted as of Apr 22, 2014