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

Y

Yi Yang

Status

Completed

Conditions

Transcranial Magnetic Stimulation

Treatments

Procedure: Sham repetitive transcranial magnetic stimulation
Procedure: Repetitive transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05843240
TMSCA-AIS

Details and patient eligibility

About

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

Full 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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 2 patient groups, including a placebo group

rTMS
Active Comparator group
Description:
Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
Treatment:
Procedure: Repetitive transcranial magnetic stimulation
sham-rTMS
Placebo Comparator group
Description:
Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
Treatment:
Procedure: Sham repetitive transcranial magnetic stimulation

Trial contacts and locations

1

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Central trial contact

Yi Yang, MD, PhD; Zhenni Guo, MD, PhD

Data sourced from clinicaltrials.gov

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