rTMS in Aphasic Patients With Neuroimage Assessments

Taipei Veterans General Hospital

Status: Unknown

Conditions: Stroke; Aphasia

Treatments: Device: Sham stimulation; Device: repetitive transcranial magnetic stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03059225

2014-05-003A

Details and patient eligibility

About

The refinement of repetitive transcranial magnetic stimulation (rTMS) has highlighted its merit in terms of learning programs as a treatment for aftereffect augmentation. Nevertheless, the efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of compound bi-hemispheric stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement.

Full description

The efficacy of synchronous rTMS protocol integrated with computer-integrated speech training is not well understood. It is also not clear regarding the efficacy of inhibitory or excitatory stimulation protocol. The aim of the study is to investigate language response to these new strategies and to determine the longevity of the therapeutic outcome. Advanced MR neuroimaging techniques, such as fMRI and DTI, are powerful tools to evaluate the concomitant nervous changes after rTMS treatment on aphasic patients. The knowledge from fMRI and DTI microstructural evolution provides insight into underlined mechanism operating the language improvement

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 3 patient groups

Experimental

Experimental group

Description:

repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.

Treatment:

Device: repetitive transcranial magnetic stimulation (rTMS)

Sham stimulation

Sham Comparator group

Description:

Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.

Treatment:

Device: Sham stimulation

High frequency rTMS

Experimental group

Description:

High-frequency rTMS to ipsilesional region for 10 daily sessions.

Treatment:

Device: repetitive transcranial magnetic stimulation (rTMS)