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

February 27, 2024 updated by: Yi Yang
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differences of phase difference (PD) at 30 minutes after transcranial magnetic stimulation under different stimulation modes (1Hz, 10 Hz, sham stimulation).
Time Frame: 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.
0-30minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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.
0-1hour; 0-6hours; 0-24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Yang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 20, 2024

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TMSCA-HA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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