Functional Neuroimage in Assessment of Post-stroke Aphasia

Stroke Clinical Trial

Official title:

Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02120508
• Other study ID #: 201207007AC
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2014
• Last updated: April 18, 2014
• Start date: August 2012
• Est. completion date: October 2015

Study information

• Verified date: April 2014
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Po-Yi Tsai, MD
• Phone: 886-228757293
• Email: pytsai[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• rTMS
To test the efficacy of this specific setting.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
vghtpe user

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concise Chinese Aphasia Test	Assess the linguistic skills such as conversation, expression, description, comprehension...	Before the rTMS intervention, at 2nd week, and 3rd month	No
Secondary	Functional MRI		Before rTMS intervention, and at the day completing the rTMS treatment.	No