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

Primary Purpose

Transcranial Magnetic Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    rTMS

    sham-rTMS

    Arm Description

    Patients are treated with repetitive transcranial magnetic stimulation (rTMS).

    Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 6, 2023
    Last Updated
    June 13, 2023
    Sponsor
    Yi Yang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05914623
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 23, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yi Yang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transcranial Magnetic Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rTMS
    Arm Type
    Active Comparator
    Arm Description
    Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
    Arm Title
    sham-rTMS
    Arm Type
    Placebo Comparator
    Arm Description
    Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
    Intervention Type
    Procedure
    Intervention Name(s)
    Repetitive transcranial magnetic stimulation
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham repetitive transcranial magnetic stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    phase difference (PD) in degree
    Description
    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.
    Time Frame
    0-5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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; Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Yang, MD,PhD
    Phone
    13756661217
    Ext
    0086
    Email
    doctoryangyi@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhenni Guo, MD,PhD
    Phone
    18186872986
    Ext
    0086
    Email
    zhen1ni2@163.com

    12. IPD Sharing Statement

    Learn more about this trial

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

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