Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
NCT ID: NCT05914623
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-06-25
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rTMS
Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
Repetitive 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).
sham-rTMS
Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
Sham 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.
Interventions
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Repetitive 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).
Sham 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Yi Yang
OTHER
Responsible Party
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Yi Yang
Vice President of First Hospital of Jilin University
Locations
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The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TMSCA-CSVD
Identifier Type: -
Identifier Source: org_study_id
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