Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
June 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedFebruary 29, 2024
February 1, 2024
9 months
June 6, 2023
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
phase difference (PD) in degree
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.
0-5 days
Study Arms (2)
rTMS
ACTIVE COMPARATORPatients are treated with repetitive transcranial magnetic stimulation (rTMS).
sham-rTMS
PLACEBO COMPARATORPatients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
Interventions
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).
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
You may qualify if:
- 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;
You may not qualify if:
- 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;
- Unwillingness to be followed up or poor adherence to treatment;
- 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;
- Other conditions that the investigators deemed unsuitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Yanglead
Study Sites (1)
The First Hospital of Jilin University
Changchun, Jilin, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President of First Hospital of Jilin University
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 22, 2023
Study Start
June 25, 2023
Primary Completion
April 1, 2024
Study Completion
July 1, 2024
Last Updated
February 29, 2024
Record last verified: 2024-02