rTMS in Aphasic Patients With Neuroimage Assessments

NCT ID: NCT03059225

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-18
• Study Completion Date: 2021-12-23

Brief Summary

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.

Detailed 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

Conditions

Stroke; Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions

Sham stimulation

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

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

2-week inhibitory non-dominate hemisphere rTMS program

High frequency rTMS

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

Group Type: EXPERIMENTAL

repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions

Interventions

repetitive transcranial magnetic stimulation (rTMS)

undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions

Intervention Type: DEVICE

Sham stimulation

2-week inhibitory non-dominate hemisphere rTMS program

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Po-Yi Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Department of physical medicine and rehabilitation, Taipei Veterans General Hospital

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Po-Yi Tsai, MD

Role: CONTACT

pytsai@vghtpe.gov.tw

886-228757293

References

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)

Chou TY, Wang JC, Lin MY, Tsai PY. Low-Frequency vs. Theta Burst Transcranial Magnetic Stimulation for the Treatment of Chronic Non-fluent Aphasia in Stroke: A Proof-of-Concept Study. Front Aging Neurosci. 2022 Jan 14;13:800377. doi: 10.3389/fnagi.2021.800377. eCollection 2021.

Reference Type: DERIVED

PMID: 35095477 (View on PubMed)

Lee IT, Huang CC, Hsu PC, Lin CP, Tsai PY. Resting-State Network Changes Following Transcranial Magnetic Stimulation in Patients With Aphasia-A Randomized Controlled Study. Neuromodulation. 2022 Jun;25(4):528-537. doi: 10.1016/j.neurom.2021.10.004. Epub 2021 Dec 18.

Reference Type: DERIVED

PMID: 35088736 (View on PubMed)

Other Identifiers

2014-05-003A

Identifier Type: -

Identifier Source: org_study_id