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

NCT ID: NCT06400407

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2025-09-15

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.

Conditions

Stroke, Acute Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Continuous Theta-burst Stimulation

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.

Group Type: EXPERIMENTAL

Continuous Theta-burst Stimulation

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

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

Continuous Theta-burst Stimulation

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.

Intervention Type: DEVICE

Sham 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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zixiao Li, MD

Role: CONTACT

lizixiao2008@hotmail.com

+8613683234256

Lingling Ding, MD

Role: CONTACT

dinglingling@bjtth.org

+8613552358752

Facility Contacts

Zixiao Li, MD

Role: primary

lizixiao2008@hotmail.com

Lingling Ding, MD

Role: backup

dinglingling@bjtth.org

References

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.

Reference Type: BACKGROUND

PMID: 37314250 (View on PubMed)

Other Identifiers

HX-C-2024001

Identifier Type: -

Identifier Source: org_study_id