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

Transcranial Magnetic Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915923
• Other study ID #: TMSCA-HA
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 20, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transcranial Magnetic Stimulation

Intervention

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)
• 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 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

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences of phase difference (PD) at 30 minutes after transcranial magnetic stimulation under different stimulation modes (1Hz, 10 Hz, sham stimulation).	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	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).	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