Functional Neuroimage in Assessment of Post-stroke Aphasia

NCT ID: NCT02120508

Last Updated: 2014-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Stroke Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1 Hz rTMS, real

1 Hz rTMS over unaffected hemisphere for 15 minutes

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

To test the efficacy of this specific setting.

1Hz rTMS, sham

1Hz sham rTMS, over unaffected hemisphere for 15 minutes

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

To test the efficacy of this specific setting.

Interventions

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rTMS

To test the efficacy of this specific setting.

Intervention Type DEVICE

Other Intervention Names

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Magstim, Rapid2

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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vghtpe user

OTHER_GOV

Sponsor Role lead

Responsible Party

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vghtpe user

Po-Yi Tsai, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Po-Yi Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Department of physical medicine and rehabilitation, Taipei Veterans General Hospital

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Po-Yi Tsai, MD

Role: CONTACT

886-228757293

Facility Contacts

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Po-Yi Tsai, MD

Role: primary

886-228757293

References

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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.

Reference Type BACKGROUND
PMID: 24526709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25378426 (View on PubMed)

Other Identifiers

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201207007AC

Identifier Type: -

Identifier Source: org_study_id

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