Back to resultsrTMS in Aphasic Patients With Neuroimage Assessments
Primary Purpose
Stroke, Aphasia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Aphasia, rTMS, Functional MRI, Speech training
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
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Experimental
Arm Label
Experimental
Sham stimulation
High frequency rTMS
Arm Description
repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.
Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.
High-frequency rTMS to ipsilesional region for 10 daily sessions.
Outcomes
Primary Outcome Measures
Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks
linguistic function assessment
Secondary Outcome Measures
Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks
brain activity change in fMRI
Full Information
NCT ID
NCT03059225
First Posted
January 16, 2017
Last Updated
January 5, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT03059225
Brief Title
rTMS in Aphasic Patients With Neuroimage Assessments
Official Title
Synchronous rTMS and Computer-integrated Speech Training Applied in Aphasic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2017 (Actual)
Primary Completion Date
December 23, 2021 (Anticipated)
Study Completion Date
December 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
Stroke, Aphasia, rTMS, Functional MRI, Speech training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
repetitive transcranial magnetic stimulation (rTMS) intervention of contralesional 1Hz-rTMS for 10 daily sessions.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham treatment for 2-week inhibitory non-dominate hemisphere rTMS program.
Arm Title
High frequency rTMS
Arm Type
Experimental
Arm Description
High-frequency rTMS to ipsilesional region for 10 daily sessions.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
2-week inhibitory non-dominate hemisphere rTMS program
Primary Outcome Measure Information:
Title
Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks
Description
linguistic function assessment
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks
Description
brain activity change in fMRI
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Yi Tsai, MD
Phone
886-228757293
Email
pytsai@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Organizational Affiliation
Department of physical medicine and rehabilitation, Taipei Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24526709
Citation
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.
Results Reference
background
PubMed Identifier
35095477
Citation
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.
Results Reference
derived
PubMed Identifier
35088736
Citation
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.
Results Reference
derived
Learn more about this trial
rTMS in Aphasic Patients With Neuroimage Assessments
We'll reach out to this number within 24 hrs