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

NCT06400407 | Completed Phase 2 DMC

• 1 other identifier: HX-C-2024001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute Ischemic

Keywords

Continuous Theta-burst Stimulation; Acute ischemic stroke; Motor recovery; Lesion network mapping; Navigation

Outcome Measures

Primary Outcomes (2)

• Improvement of motor function

  Fugl-Meyer motor function score (FMMS) change from baseline at 7 days. FMMS 0-100 (higher score indicates better)

  7 days

• Serious adverse events ( SAEs )

  Serious adverse events ( SAEs )

  7 days

Secondary Outcomes (11)

• Early neurological improvement (ENI)

  7 days

• Improvement of motor function

  90 days

• Excellent functional outcome

  90 days

• Funtional outcome

  90 days

• Barthel index of ADL

  90 days

Study Arms (2)

Continuous Theta-burst Stimulation

EXPERIMENTAL

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.

Device: Continuous Theta-burst Stimulation

Sham stimulation

SHAM COMPARATOR

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.

Device: Sham stimulation

Interventions

Sham stimulation 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.

Sham stimulation

Continuous Theta-burst Stimulation 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.

Continuous Theta-burst Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old.
• Acute ischemic stroke confirmed by CT or MRI at 14 days after onset.
• Pre-stroke modified Rankin scale (mRS) score≤1.
• ≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least.
• Moderate or severe motor dysfunction (Fugl-Meyer motor score \< 80).
• Written informed consent from patients or their legally authorized representatives.

You may not qualify if:

• TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
• Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
• Midline displacement and brain parenchymal mass effect seen in head CT and other images;
• Head CT or MRI showed bilateral acute cerebral infarction;
• Evidence of acute intracranial hemorrhage;
• A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
• After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
• Patients during pregnancy or lactation and within 90 days of planned pregnancy;
• Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up;
• Patients with malignancy or severe systemic disease and expected survival of less than 90 days;
• Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
• Patients with ataxia (NIHSS 7 ≥ 1) and aphasia (NIHSS 9 ≥ 2).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• 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.

  PMID: 37314250 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: October 21, 2024
• Primary Completion: October 27, 2025
• Study Completion: January 12, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)