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Clinical Trials/NCT05914623
NCT05914623
Recruiting
Not Applicable

Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease

Yi Yang1 site in 1 country80 target enrollmentJune 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transcranial Magnetic Stimulation
Sponsor
Yi Yang
Enrollment
80
Locations
1
Primary Endpoint
phase difference (PD) in degree
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

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 stroke. The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

Registry
clinicaltrials.gov
Start Date
June 25, 2023
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yi Yang
Responsible Party
Sponsor Investigator
Principal Investigator

Yi Yang

Vice President of First Hospital of Jilin University

The First Hospital of Jilin University

Eligibility Criteria

Inclusion Criteria

  • Age 18-80 years, regardless of gender;
  • Diagnosed with CSVD, and neuroimaging presented as recent small subcortical infarcts;
  • Initiated transcranial magnetic stimulation within 7 days of onset;
  • Subject or legal representative agreed to the treatment and signed the informed consent;

Exclusion Criteria

  • Vascular stenosis \> 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;
  • Previous history of atrial fibrillation or myocardial infarction within 6 months;
  • Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;
  • White matter hyperintensities (WMH) of non-vascular origin;
  • Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;
  • Patients with contraindications to transcranial magnetic stimulation, such as metal or electronic devices in the brain;
  • Pregnant or breastfeeding women;
  • The patients with disorders of consciousness, agitation or insufficient bilateral temporal bone windows for insonation who cannot cooperate to dynamic cerebral autoregulation monitoring;
  • Previous history of epilepsy or family history of epilepsy;
  • Previous treatment with transcranial magnetic stimulation or its equivalent;

Outcomes

Primary Outcomes

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.

Study Sites (1)

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