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Functional Neuroimage in Assessment of Post-stroke Aphasia

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ClinicalTrials.gov Identifier: NCT02120508
Recruitment Status : Unknown
Verified April 2014 by vghtpe user, Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : April 22, 2014
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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
Stroke Aphasia Device: rTMS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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 Name: 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 Name: Magstim, Rapid2




Primary Outcome Measures :
  1. Concise Chinese Aphasia Test [ Time Frame: 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 [ Time Frame: Before rTMS intervention, and at the day completing the rTMS treatment. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120508


Contacts
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Contact: Po-Yi Tsai, MD 886-228757293 pytsai@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Po-Yi Tsai, MD    886-228757293      
Sponsors and Collaborators
vghtpe user
Investigators
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Principal Investigator: Po-Yi Tsai, MD Department of physical medicine and rehabilitation, Taipei Veterans General Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: vghtpe user, Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02120508     History of Changes
Other Study ID Numbers: 201207007AC
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014

Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
stroke
aphasia
rTMS
Functional MRI
Speech training

Additional relevant MeSH terms:
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Language Disorders
Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms