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Completed

NCT Number: NCT06400407

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 4≤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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Improvement of motor function

    Time frame: 7 days

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

  2. Serious adverse events ( SAEs )

    Time frame: 7 days

    Serious adverse events ( SAEs )

Secondary outcomes

  1. Early neurological improvement (ENI)

    Time frame: 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)

  2. Improvement of motor function

    Time frame: 90 days

    Fugl-Meyer motor function score (FMMS) change from baseline at 90 days. FMMS 0-100 (higher score indicates better)

  3. Excellent functional outcome

    Time frame: 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)

  4. Funtional outcome

    Time frame: 90 days

    Proportion of patients with an mRS score of 0-2 at Day 90 (± 7 days) post-randomization.

  5. Barthel index of ADL

    Time frame: 90 days

    Barthel index of ADL, 0-100 (higher score indicates better)

  6. EQ-5D-5L

    Time frame: 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."

  7. Symptomatic intracranial hemorrhage

    Time frame: 7 days

    Proportion of symptomatic intracranial hemorrhage (sICH)

  8. Symptomatic intracranial hemorrhage

    Time frame: 90 days

    Proportion of symptomatic intracranial hemorrhage (sICH)

  9. Mortality

    Time frame: 90 days

    Rate of death from any cause within 90 days

  10. Adverse events ( AEs )

    Time frame: 90 days

    Rate of adverse events ( AEs ) within 90 days

  11. Stroke recurrence

    Time frame: 90 days

    Cerebral infarction, cerebral hemorrhage

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study 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

Acronym: MASTRE

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 6, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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