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

Not Applicable

Recruiting

• Conditions: Transcranial Magnetic Stimulation
• Interventions: Procedure: 1 Hz Repetitive transcranial magnetic stimulation; Procedure: 10 Hz Repetitive transcranial magnetic stimulation; Procedure: Sham Repetitive transcranial magnetic stimulation

• Registration Number: NCT05915923
• Lead Sponsor: Yi Yang

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.

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 Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Study Start: 2023-08-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-frequency rTMS Group	1 Hz Repetitive transcranial magnetic stimulation	Healthy adults treated with 1Hz repetitive transcranial magnetic stimulation (rTMS)
High-frequency rTMS Group	10 Hz Repetitive transcranial magnetic stimulation	Healthy adults treated with 10Hz repetitive transcranial magnetic stimulation (rTMS)
Control group	Sham Repetitive transcranial magnetic stimulation	The Control group received rTMS with sham transcranial magnetic stimulation (sham-rTMS)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Jilin, China