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The objective of this trial is to evaluate the effectiveness and safeness of different doses of continuous Theta Burst Stimulation (cTBS) over the right Superior Frontal Gyrus (SFG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-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, 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 personalized rTMS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following six groups: active 1200-pulse cTBS group, active 2400-pulse cTBS group, active 3600-pulse cTBS group, sham 1200-pulse cTBS group, sham 2400-pulse cTBS group, or sham 3600-pulse cTBS group. The allocation ratio will be 3:3:3:1:1:1. 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 1200-pulse cTBS group | Active Comparator | active 1200-pulse cTBS combined with speech language therapy |
|
| active 2400-pulse cTBS group | Active Comparator | active 2400-pulse cTBS combined with speech language therapy |
|
| active 3600-pulse cTBS group | Active Comparator | active 3600-pulse cTBS combined with speech language therapy |
|
| sham 1200-pulse cTBS group | Sham Comparator | sham 1200-pulse cTBS combined with speech language therapy |
|
| sham 2400-pulse cTBS group | Sham Comparator | sham 2400-pulse cTBS combined with speech language therapy |
|
| sham 3600-pulse cTBS group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active 1200-pulse continuous Theta Burst Stimulation | Device | Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 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 | |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Nanshi Hospital of Nanyang | Recruiting | Nanyang | Henan | China |
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| Sham Comparator |
sham 3600-pulse cTBS combined with speech language therapy |
|
| active 2400-pulse continuous Theta Burst Stimulation | Device | Each patient will receive two 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week. |
|
| active 3600-pulse continuous Theta Burst Stimulation | Device | Each patient will receive two 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 5 consecutive workdays each week. |
|
| sham 1200-pulse continuous Theta Burst Stimulation | Device | Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week. |
|
| sham 2400-pulse continuous Theta Burst Stimulation | Device | Each patient will receive two sham 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week. |
|
| sham 3600-pulse continuous Theta Burst Stimulation | Device | Each patient will receive two sham 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 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 |
| 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 |
| The fifth Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
|
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| 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 |
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