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

Not Applicable

Completed

• Conditions: Transcranial Magnetic Stimulation

• Registration Number: NCT05843240
• Lead Sponsor: Yi Yang

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-06
• Study Start: 2023-05-07
• Primary Completion: 2024-03-03
• Study Completion: 2024-06-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
phase difference(PD) in degree	0-5 days	A cerebral autoregulation parameter derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the cerebral autoregulatory parameter.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China