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Efficacy and safety study of repetitive transcranial magnetic stimulation for acute ischemic stroke: a multicenter, randomized, parallel controlled clinical study

Efficacy and safety study of repetitive transcranial magnetic stimulation for acute ischemic stroke: a multicenter, randomized, parallel controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115472
Enrollment
Unknown
Registered
2025-12-26
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

Test group:rTMS treatment
Control group:sham-rTMS treantment

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >=18 years, regardless of gender; (2) A clear clinical diagnosis of acute anterior circulation ischemic stroke; (3) Baseline (pre-randomization) NIHSS score of 6–16, with a single-limb item score >=2; (4) Pre-stroke modified Rankin Scale (mRS) score <=1; (5) Ability to complete randomization and initiate transcranial magnetic stimulation within 3 days of symptom onset; (6) Written informed consent provided by the participant or their legally authorized representative.

Exclusion criteria

Exclusion criteria: (1) Intracranial hemorrhagic conditions identified on neuroimaging, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, and subarachnoid hemorrhage; (2) Presence of severe cognitive impairment or psychiatric disorders; (3) Presence of severe systemic disease or a history of cranial/brain surgery; (4) A history of epilepsy, a family history of epilepsy, or the presence of factors predisposing to epileptic seizures; (5) Known pregnancy or breastfeeding; (6) Presence of metallic foreign bodies near the stimulation site, such as intracranial metal implants, cochlear implants, or implanted pulse generators (e.g., brain stimulators or cardiac pacemakers); (7) Patients with an expected survival of less than 3 months, or those unable to complete the study for other reasons; (8) Unwillingness to undergo follow-up or poor treatment adherence; (9) Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial; (10) Any other condition deemed unsuitable for enrollment by the investigators.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with an mRS score of 0-1 at 90 days;

Secondary

MeasureTime frame
The proportion of patients with an mRS score of 0-2 at 90 days;The distribution of mRS scores at 90 days;The proportion of patients with early neurological improvement between the two groups (defined as a reduction of =4 in the NIHSS score from baseline, or an NIHSS score of 0–1 at the end of the 7-day rTMS/sham-rTMS treatment).;The proportion of patients with early neurological deterioration between the two groups (defined as an increase of =4 in the NIHSS score from baseline at the end of the 7-day rTMS/sham-rTMS treatment);The NIHSS scores between the two groups after 7 days of treatment;The final cerebral infarct volume between the two groups;

Countries

China

Contacts

Public ContactYi Yang

The First Hospital of Jilin University

doctoryangyi@163.com+86 431 8878 2378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026