rTMS in Aphasic Patients With Neuroimage Assessments

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03059225
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 58.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Aphasia	Device: repetitive transcranial magnetic stimulation (rTMS); Device: Sham stimulation	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Synchronous rTMS and Computer-integrated Speech Training Applied in Aphasic Patients
• Actual Study Start Date: Feb 18, 2017
• Anticipated Primary Completion Date: Dec 23, 2021
• Anticipated Study Completion Date: Dec 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.	Device: repetitive transcranial magnetic stimulation (rTMS); undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions
Sham Comparator: Sham stimulation Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.	Device: Sham stimulation; 2-week inhibitory non-dominate hemisphere rTMS program
Experimental: High frequency rTMS High-frequency rTMS to ipsilesional region for 10 daily sessions.	Device: repetitive transcranial magnetic stimulation (rTMS); undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks [Up to 12 weeks]

   linguistic function assessment

Secondary Outcome Measures

1. Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks [Up to 12 weeks]

   brain activity change in fMRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

• Principal Investigator: Po-Yi Tsai, MD, Department of physical medicine and rehabilitation, Taipei Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: vghtpe user, Principal investigator, Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT03059225
• Other Study ID Numbers: 2014-05-003A
• First Posted: Feb 23, 2017
• Last Update Posted: Jan 8, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by vghtpe user, Principal investigator, Taipei Veterans General Hospital, Taiwan: Stroke; Aphasia; rTMS; Functional MRI; Speech training
• Additional relevant MeSH terms: Aphasia

Study Results

No Results Posted as of Jan 8, 2021