Clinical trial NCT03059225: rTMS in Aphasic Patients With Neuroimage Assessments
Official title: Synchronous rTMS and Computer-integrated Speech Training Applied in Aphasic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Aphasia
Keywords: Stroke
Aphasia
rTMS
Functional MRI
Speech training
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change From Baseline in aphasia level on the Concise Chinese Aphasia Test (CCAT) at 2 Weeks
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change from Baseline in the concomitant nervous status on the Functional magnetic resonance imaging (fMRI) at 2 weeks
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Department of physical medicine and rehabilitation, Taipei Veterans General Hospital
name: Po-Yi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.