Clinical trial NCT05914623: Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
Official title: Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: phase difference (PD) in degree
timeFrame: 0-5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: