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Completed

NCT Number: NCT05843240

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jilin University

Changchun, Jilin, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Presence of a medical condition such as severe cognitive impairment or mental impairment;
  • Patients with serious physical diseases or who have had craniocerebral surgery;
  • Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors;
  • Pregnancy or breastfeeding;
  • 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.;
  • Patients who are unable to complete cerebral autoregulation, or bilateral temporal window penetration poorly;
  • life expectancy of ≤3 months or inability to complete the study for other reasons;
  • unwillingness to be followed up or poor treatment compliance;
  • 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;
  • Other conditions that the investigators deemed unsuitable for enrollment.

Treatment and study plan

repetitive transcranial magnetic stimulation

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 repetitive transcranial magnetic stimulation

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.

Primary outcomes

  1. phase difference(PD) in degree

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Apr 30, 2025

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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