Functional Neuroimage in Assessment of Post-stroke Aphasia

Not Applicable

• Conditions: Stroke; Aphasia
• Interventions: Device: rTMS

• Registration Number: NCT02120508
• Lead Sponsor: vghtpe user

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.

Study Timeline

• Study Start: 2012-08
• Status Verified: 2014-04
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-18
• Last Update Submitted: 2014-04-18
• Study First Posted: 2014-04-22
• Last Update Posted: 2014-04-22
• Primary Completion: 2015-08
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1Hz rTMS, sham	rTMS	1Hz sham rTMS, over unaffected hemisphere for 15 minutes
1 Hz rTMS, real	rTMS	1 Hz rTMS over unaffected hemisphere for 15 minutes

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Functional MRI	Before rTMS intervention, and at the day completing the rTMS treatment.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan