Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedStudy Start
First participant enrolled
August 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2024
CompletedFebruary 29, 2024
February 1, 2024
8 months
May 22, 2023
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (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
Study Arms (3)
Low-frequency rTMS Group
EXPERIMENTALHealthy adults treated with 1Hz repetitive transcranial magnetic stimulation (rTMS)
High-frequency rTMS Group
EXPERIMENTALHealthy adults treated with 10Hz repetitive transcranial magnetic stimulation (rTMS)
Control group
SHAM COMPARATORThe Control group received rTMS with sham transcranial magnetic stimulation (sham-rTMS)
Interventions
After enrollment, healthy adults received rTMS once a day (stimulation plan: stimulation of M1 region on the dominant hemisphere at 1Hz)
After enrollment, healthy adults received rTMS once a day (stimulation plan: stimulation of M1 region on the dominant hemisphere at 10Hz)
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
Eligibility Criteria
You may qualify if:
- Age≥18 years, \< 60 years, both genders；
- Willing to participate and sign the informed consent；
- Bilateral temporal windows were well penetrated;
You may not qualify if:
- 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;
- Suffering from infectious diseases in late one month;
- Pregnancy or breast-feeding;
- Sleep disorders, anxiety and depression,
- Alcohol or drug abuse;
- History of prescription drugs or over-the-counter (OTC) drugs in the past 2 weeks;
- History of epilepsy or family history of epilepsy;
- Implants ( stents or metals );
- Other conditions that the researchers think are not suitable for the project.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Yanglead
Study Sites (1)
The First Hospital of Jilin University
Jilin, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President of First Hospital of Jilin University
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 23, 2023
Study Start
August 2, 2023
Primary Completion
April 1, 2024
Study Completion
April 20, 2024
Last Updated
February 29, 2024
Record last verified: 2024-02