Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke

NCT ID: NCT05843240

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-07

Study Completion Date

2024-06-03

Brief Summary

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The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

Detailed Description

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Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with ischemic stroke. The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

Conditions

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Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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rTMS

Patients are treated with repetitive transcranial magnetic stimulation (rTMS).

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

After enrollment, patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).

sham-rTMS

Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).

Group Type PLACEBO_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

After enrollment, patients received sham-rTMS once a day for 5 consecutive days with the same parameters as the rTMS group, but the coil was rotated 90° away from the scalp.

Interventions

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Repetitive transcranial magnetic stimulation

After enrollment, patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).

Intervention Type PROCEDURE

Sham repetitive transcranial magnetic stimulation

After enrollment, patients received sham-rTMS once a day for 5 consecutive days with the same parameters as the rTMS group, but the coil was rotated 90° away from the scalp.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years, both sexes;
2. Clinically definite diagnosis of acute ischemic stroke;
3. Baseline National Institute of Health Stroke Scale (NIHSS) score ≤25;
4. Pre-onset modified Rankin Scale (mRS) score ≤1;
5. Randomized and initiated transcranial magnetic stimulation within 1 week of onset;
6. Subject or legal representative agreed to the treatment and signed the informed consent.

Exclusion Criteria

1. Presence of a medical condition such as severe cognitive impairment or mental impairment;
2. Patients with serious physical diseases or who have had craniocerebral surgery;
3. Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors;
4. Pregnancy or breastfeeding;
5. The presence of metal foreign bodies near the stimulation site, such as intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers), etc.;
6. Patients who are unable to complete cerebral autoregulation, or bilateral temporal window penetration poorly;
7. life expectancy of ≤3 months or inability to complete the study for other reasons;
8. unwillingness to be followed up or poor treatment compliance;
9. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study;
10. Other conditions that the investigators deemed unsuitable for enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yi Yang

OTHER

Sponsor Role lead

Responsible Party

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Yi Yang

Vice President of First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

Other Identifiers

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TMSCA-AIS

Identifier Type: -

Identifier Source: org_study_id

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