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RecruitingNCT05914623Updated Feb 29, 2024

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

An interventional study of Repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation in Transcranial Magnetic Stimulation, sponsored by Yi Yang. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Yi Yang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Transcranial Magnetic Stimulation
03

In context

Cerebral Small Vessel Diseases

121 studies on the registry are indexed under Cerebral Small Vessel Diseases; 66 are open to participants now.

This study's planned enrollment of 80 is close to the median of 84 across 69 interventional studies indexed under Cerebral Small Vessel Diseases.

Browse Cerebral Small Vessel Diseases studies →

Lead sponsor

Yi Yang is the lead sponsor of 41 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    rTMS

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

    Procedure: Repetitive transcranial magnetic stimulation

  • Placebo comparator
    sham-rTMS

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

    Procedure: Sham repetitive transcranial magnetic stimulation

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.

06

What researchers measure

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.

    Time frame: 0-5 days

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05914623
Lead sponsor
Yi Yang
Responsible party
Yi Yang (Vice President of First Hospital of Jilin University, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Jun 22, 2023
Start date
Jun 25, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Feb 29, 2024

Study contacts

Yi Yang, MD,PhD
Contact
doctoryangyi@163.com
13756661217 ext. 0086
Zhenni Guo, MD,PhD
Contact
zhen1ni2@163.com
18186872986 ext. 0086

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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