Clinical trial NCT06400407: Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke
Official title: Lesion Network Mapping Navigated Continuous Theta-burst Stimulation for Motor Recovery in Acute Ischemic Stroke:A Randomized, Double-Blind, Sham-Controlled, Phase 2 Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Stroke, Acute Ischemic
Keywords: Continuous Theta-burst Stimulation
Acute ischemic stroke
Motor recovery
Lesion network mapping
Navigation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 at 3-14 days after 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years old.
2. Acute ischemic stroke confirmed by CT or MRI at 3-14 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).

Primary outcomes:
measure: Improvement of motor function
timeFrame: 7 days
measure: Serious adverse events ( SAEs )
timeFrame: 7 days
Secondary outcomes:
measure: Early neurological improvement (ENI)
timeFrame: 7 days
measure: Improvement of motor function
timeFrame: 90 days
measure: Excellent functional outcome
timeFrame: 90 days
measure: Barthel index of ADL
timeFrame: 90 days
measure: EQ-5D-5L
timeFrame: 90 days
measure: Symptomatic intracranial hemorrhage
timeFrame: 7 days
measure: Symptomatic intracranial hemorrhage
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: Adverse events ( AEs )
timeFrame: 90 days
measure: Stroke recurrence
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
citation: Ding L, Liu H, Jing J, Jiang Y, Meng X, Chen Y, Zhao X, Niu H, Liu T, Wang Y, Li Z. Lesion Network Mapping for Neurological Deficit in Acute Ischemic Stroke. Ann Neurol. 2023 Sep;94(3):572-584. doi: 10.1002/ana.26721. Epub 2023 Jun 27.