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

Yi Yang

Status: Enrolling

Conditions: Transcranial Magnetic Stimulation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05914623

TMSCA-CSVD

Details and patient eligibility

About

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.

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Vascular stenosis > 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;
2. Previous history of atrial fibrillation or myocardial infarction within 6 months;
3. Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;
4. White matter hyperintensities (WMH) of non-vascular origin;
5. Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;
6. Patients with contraindications to transcranial magnetic stimulation, such as metal or electronic devices in the brain;
7. Pregnant or breastfeeding women;
8. The patients with disorders of consciousness, agitation or insufficient bilateral temporal bone windows for insonation who cannot cooperate to dynamic cerebral autoregulation monitoring;
9. Previous history of epilepsy or family history of epilepsy;
10. Previous treatment with transcranial magnetic stimulation or its equivalent;
11. Unwillingness to be followed up or poor adherence to treatment;
12. 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;
13. Other conditions that the investigators deemed unsuitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 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