Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke (MASTRE)

Capital Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Stroke, Acute Ischemic

Treatments: Device: Sham stimulation; Device: Continuous Theta-burst Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06400407

HX-C-2024001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Continuous Theta-burst Stimulation

Experimental group

Description:

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 treatment course lasted for 7 days.

Treatment:

Device: Continuous Theta-burst Stimulation

Sham stimulation

Sham Comparator group

Description:

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 treatment course lasted for 7 days.

Treatment:

Device: Sham stimulation