Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults

Sponsor
Yi Yang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05915923
Collaborator
(none)
90
3
10.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of transcranial magnetic stimulation with different stimulation modes ( 1Hz, 10Hz, sham stimulation ) on cerebral autoregulation.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 1 Hz Repetitive transcranial magnetic stimulation
  • Procedure: 10 Hz Repetitive transcranial magnetic stimulation
  • Procedure: Sham Repetitive transcranial magnetic stimulation
N/A

Detailed Description

Current studies have shown that repetitive transcranial magnetic stimulation (TMS) can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with ischemic stroke.Dynamic cerebral autoregulation (dCA), refers to a complex process in which small intracranial arteries contract or relax to maintain relatively stable cerebral blood volume when systemic arterial blood pressure changes, which can predict the prognosis of patients with ischemic stroke. In this study, we hypothesis that TMS provides neuro-protection by means of improving dCA.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults
Anticipated Study Start Date :
Jun 14, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low-frequency rTMS Group

Healthy adults treated with 1Hz repetitive transcranial magnetic stimulation (rTMS)

Procedure: 1 Hz Repetitive transcranial magnetic stimulation
After enrollment, healthy adults received rTMS once a day (stimulation plan: stimulation of M1 region on the dominant hemisphere at 1Hz)

Experimental: High-frequency rTMS Group

Healthy adults treated with 10Hz repetitive transcranial magnetic stimulation (rTMS)

Procedure: 10 Hz Repetitive transcranial magnetic stimulation
After enrollment, healthy adults received rTMS once a day (stimulation plan: stimulation of M1 region on the dominant hemisphere at 10Hz)

Sham Comparator: Control group

The Control group received rTMS with sham transcranial magnetic stimulation (sham-rTMS)

Procedure: Sham Repetitive transcranial magnetic stimulation
After enrollment, healthy adults received sham-rTMS once a day with the same parameters as the 10 Hz rTMS group, but the coil rotated 90° away from the scalp

Outcome Measures

Primary Outcome Measures

  1. The differences of phase difference (PD) at 30 minutes after transcranial magnetic stimulation under different stimulation modes (1Hz, 10 Hz, sham stimulation). [0-30minutes]

    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

  1. To compare the difference of phase difference (PD) at 1hour, 6hours and 24hours after transcranial magnetic stimulation under different stimulation modes (1Hz, 10Hz, sham stimulation). [0-1hour; 0-6hours; 0-24hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age≥18 years, < 60 years, both genders;

  2. Willing to participate and sign the informed consent;

  3. Bilateral temporal windows were well penetrated;

Exclusion Criteria:
  1. Complaints of previous or existing chronic organic diseases ( stroke, Parkinson 's disease, hypertension, diabetes, etc. ), mental diseases ( bipolar disorder, personality disorder, schizophrenia, etc. ), or cognitive impairment;

  2. Suffering from infectious diseases in late one month;

  3. Pregnancy or breast-feeding;

  4. Sleep disorders, anxiety and depression,

  5. Alcohol or drug abuse;

  6. History of prescription drugs or over-the-counter (OTC) drugs in the past 2 weeks;

  7. History of epilepsy or family history of epilepsy;

  8. Implants ( stents or metals );

  9. Other conditions that the researchers think are not suitable for the project.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yi Yang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yi Yang, Vice President of First Hospital of Jilin University, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT05915923
Other Study ID Numbers:
  • TMSCA-HA
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yi Yang, Vice President of First Hospital of Jilin University, The First Hospital of Jilin University

Study Results

No Results Posted as of Jun 23, 2023