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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05914623
Enrollment
80
Registered
2023-06-22
Start date
2023-06-25
Completion date
2024-07-01
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcranial Magnetic Stimulation

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.

Interventions

PROCEDURERepetitive transcranial magnetic stimulation

After enrollment, the patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).

PROCEDURESham repetitive transcranial magnetic stimulation

After enrollment, the 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.

Sponsors

Yi Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
phase difference (PD) in degree0-5 daysA 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.

Countries

China

Contacts

Primary ContactYi Yang, MD,PhD
doctoryangyi@163.com13756661217
Backup ContactZhenni Guo, MD,PhD
zhen1ni2@163.com18186872986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026