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In this study, a randomized, double-blind, parallel-controlled trial was employed to evaluate the effectiveness and safety of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) and the superior frontal gyrus (SFG) for language function recovery in post-stroke aphasic patients.
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, investigators 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 multi-target rTMS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS) group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol consisted of a 3-week treatment, with 5 consecutive workdays 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 cTBS group | Active Comparator | active cTBS combined with speech language therapy |
|
| sham cTBS group | Sham Comparator | sham cTBS combined with speech language therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active continuous Theta Burst Stimulation | Device | Each patient will receive a series of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, and subsequently a 600-pulse cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week. |
| 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 | |
|---|---|---|---|---|
| Jianting Huang, MD,PhD | Contact | 010-80726688 | jianting.huang@pku.edu.cn | |
| Ruiqi Pan | Contact | 010-80726688 | ruiqipanedu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hesheng Liu, PhD | Changping Laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Hebei University | Recruiting | Baoding | Hebei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38754874 | Derived | Huang J, Ren J, Xie W, Pan R, Xu N, Liu H. Personalised functional imaging-guided multitarget continuous theta burst stimulation for post-stroke aphasia: study protocol for a randomised controlled trial. BMJ Open. 2024 May 15;14(5):e081847. doi: 10.1136/bmjopen-2023-081847. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| sham continuous Theta Burst Stimulation | Device | Each patient will receive a series of stimulation sequences,including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, and subsequently a 600-pulse sham cTBS targeting at the right SFG. This sequence will be repeated once more (a total of 3600 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week. |
|
| 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 |
| Token test | The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities. | 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 |
| Affiliated Hospital of Chengde Medical University | Recruiting | Chengde | Hebei | China |
|
| Hebei General Hospital | Recruiting | Shijiazhuang | Hebei | China |
|
| 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 |