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The current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions in patients with post-ischemic stroke aphasia.
Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases, including treating post-stroke symptoms. Using the personalized brain functional sectors (pBFS) technique, we could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data. The current study proposes to conduct a double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized cTBS combined with iTBS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following two groups: active TBS(cTBS+iTBS)group, or a sham TBS(sham cTBS+sham iTBS)group. The allocation ratio will be 1:1. The stimulation protocol consisted of a 3-week treatment, with five consecutive days each week (totally 15 day-treatment) .The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active TBS group | Active Comparator | active TBS combined with speech language therapy |
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| sham TBS group | Sham Comparator | sham TBS combined with speech language therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active cTBS combined with iTBS | Device | Daily TBS treatment consists of the following combination: active 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + active 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + active 600-pulse cTBS applied to the SFG in the unaffected hemisphere + active 600-pulses iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Western Aphasia Battery scores | The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities. | baseline, end of the 3-week therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Western Aphasia Battery scores | The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruiqi Pan | Contact | 010-80726688 | ruiqipanedu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hesheng Liu, Ph.D. | Changping Laboratory | Study Chair |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| sham cTBS combined with iTBS | Device | Daily sham TBS treatment consists of the following combination: sham 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + sham 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + sham 600-pulse cTBS applied to the SFG in the unaffected hemisphere + 600-pulse sham iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of sham TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks. |
|
| baseline, end of the 5-day therapy, 90 days after treatment initiation |
| Boston Diagnostic Aphasia Examination Severity Ratings | The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities.BDAE severity ratings range from level 0 to level 5, with lower scores indicating more severe aphasia. | baseline,end of the 3-week therapy,90 days after treatment initiation |
| Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g) | The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from "not at all" to "very much", with higher scores indicating better quality of life. | baseline,end of the 3-week therapy,90 days after treatment initiation |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |