Stroke, Acute Ischemic
Conditions
Keywords
Continuous Theta-burst Stimulation, Acute ischemic stroke, Motor recovery, Lesion network mapping, Navigation
Brief summary
This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke within 14 days of symptom onset.
Detailed description
The target population of this study was patients with acute ischemic stroke. Lesion network mapping and navigation were used to select individual stimulation targets. Enrolled patients were randomly assigned in a 1:1 ratio to the "cTBS group" or the "Sham stimulation group" and received: cTBS group: Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days. Sham stimulation group: A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.
Interventions
Based on the map, an 8-shaped coil was used to stimulate the motor function-related targets. The stimulation intensity was RMT80%, 600 pulses, 50Hz, 40s per target, and the stimulation interval was more than 2 hours. The total course of treatment lasted 7 days.
DEVICESham stimulation
A Sham stimulation coil was used to stimulate based on the map. The sound and duration were the same as the cTBS group, ensuring no effective stimulation. The total course of treatment lasted 7 days.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
To ensure the blind method, the sham stimulation coil will be used, which has the same parameters (including stimulation frequency, time, etc.) as the cTBS group, and has the same stimulation sound to ensure no effective stimulation, to ensure the blind state is maintained during the test. Investigators and patients who participate in the study treatment or are involved in the clinical evaluation of patients will be blinded to treatment grouping.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years old. 2. Acute ischemic stroke confirmed by CT or MRI at 14 days after onset. 3. Pre-stroke modified Rankin scale (mRS) score≤1. 4. 4≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least. 5. Moderate or severe motor dysfunction (Fugl-Meyer motor score \< 80). 6. Written informed consent from patients or their legally authorized representatives.
Exclusion criteria
1. TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc. 2. Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders; 3. Midline displacement and brain parenchymal mass effect seen in head CT and other images; 4. Head CT or MRI showed bilateral acute cerebral infarction; 5. Evidence of acute intracranial hemorrhage; 6. A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease; 7. After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg; 8. Patients during pregnancy or lactation and within 90 days of planned pregnancy; 9. Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up; 10. Patients with malignancy or severe systemic disease and expected survival of less than 90 days; 11. Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies. 12. Patients with ataxia (NIHSS 7 ≥ 1) and aphasia (NIHSS 9 ≥ 2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of motor function | 7 days | Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better) |
| Serious adverse events ( SAEs ) | 7 days | Serious adverse events ( SAEs ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early neurological improvement (ENI) | 7 days | The proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1. NIHSS 0-42 (lower score indicates better) |
| Improvement of motor function | 90 days | Fugl-Meyer motor function score (FMMS) change from baseline at 90 days. FMMS 0-100 (higher score indicates better) |
| Excellent functional outcome | 90 days | Proportion of patients with an mRS score of 0-1 at Day 90 (± 7 days) post-randomization. mRS 0-6 (lower score indicates better) |
| Funtional outcome | 90 days | Proportion of patients with an mRS score of 0-2 at Day 90 (± 7 days) post-randomization. |
| Barthel index of ADL | 90 days | Barthel index of ADL, 0-100 (higher score indicates better) |
| EQ-5D-5L | 90 days | he Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems." |
| Symptomatic intracranial hemorrhage | 7 days | Proportion of symptomatic intracranial hemorrhage (sICH) |
| Mortality | 90 days | Rate of death from any cause within 90 days |
| Adverse events ( AEs ) | 90 days | Rate of adverse events ( AEs ) within 90 days |
| Stroke recurrence | 90 days | Cerebral infarction, cerebral hemorrhage |
Countries
China
Outcome results
None listed