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The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic 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, 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 multi-center, double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized TMS 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 2:1. Subjects will receive a 3-week treatment for 21 consecutive days. 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 conventional rehabilitation therapy |
|
| sham cTBS group | Sham Comparator | Sham cTBS combined with conventional rehabilitation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active cTBS | Device | Each patient will receive three 600-pulse cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 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 into an Aphasia Quotient, lower scores indicate worse outcomes. | baseline, end of the 21-day 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 into an Aphasia Quotient, lower scores indicate worse outcomes. |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Rehabilitation Research Center | Recruiting | Beijing | China |
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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 | Device | Each patient will receive three 600-pulse sham cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks). |
|
| baseline, end of the 7-day therapy, end of the follow-up of 3 weeks |
| National Institute of Health stroke scale | The 11-item National Institutes of Health Stroke Scale (NIHSS) will be used to evaluate participants' degree of neural deficits after stroke. Each item is associated with a specific ability, each scores between 0 to 4. The individual scores will be summed to calculate a participant's total NIHSS score. The total possible score is between 0 to 42, higher scores indicate worse outcomes. | baseline, end of the 21-day therapy |
| 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 |