Transcranial Magnetic StimulationNCT05915923
Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults
A study testing 1 Hz Repetitive transcranial magnetic stimulation and 10 Hz Repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Yi Yang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Magnetic Stimulation
- What is being tested?
- 1 Hz Repetitive transcranial magnetic stimulation and 10 Hz Repetitive transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age≥18 years, < 60 years, both genders；
- Willing to participate and sign the informed consent；
- Bilateral temporal windows were well penetrated;
Who cannot join
- 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;
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- History of epilepsy or family history of epilepsy;
- Implants ( stents or metals );
- Other conditions that the researchers think are not suitable for the project.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Jilin City
Yi Yang, MD,PhD, doctor_yangyi@163.com
About this study
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.
Read the 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.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- 1 Hz Repetitive transcranial magnetic stimulation, 10 Hz Repetitive transcranial magnetic stimulation, Sham Repetitive transcranial magnetic stimulation
- Keywords
- transcranial magnetic stimulation, healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Hz Repetitive transcranial magnetic stimulationProcedure or surgery
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 stimulationProcedure or surgery
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 stimulationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Low-frequency rTMS Group | Experimental | Healthy adults treated with 1Hz repetitive transcranial magnetic stimulation (rTMS) Receives: Procedure: 1 Hz Repetitive transcranial magnetic stimulation |
| High-frequency rTMS Group | Experimental | Healthy adults treated with 10Hz repetitive transcranial magnetic stimulation (rTMS) Receives: Procedure: 10 Hz Repetitive transcranial magnetic stimulation |
| Control group | Sham comparator | The Control group received rTMS with sham transcranial magnetic stimulation (sham-rTMS) Receives: Procedure: Sham Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 0-1hour; 0-6hours; 0-24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start2 Aug 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915923
- Sponsor's protocol ID
- TMSCA-HA
- Status last verified
- Feb 2024
- First submitted
- 22 May 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation on Dynamic Cerebral Autoregulation in Healthy Adults
- ClinicalTrials.gov ID
- NCT05915923
- Acronym / sponsor ID
- TMSCA-HA
- Conditions
- Transcranial Magnetic Stimulation
- Keywords
- transcranial magnetic stimulation, healthy adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-frequency rTMS Group | Experimental | Procedure: 1 Hz Repetitive transcranial magnetic stimulationHealthy adults treated with 1Hz repetitive transcranial magnetic stimulation (rTMS) |
| High-frequency rTMS Group | Experimental | Procedure: 10 Hz Repetitive transcranial magnetic stimulationHealthy adults treated with 10Hz repetitive transcranial magnetic stimulation (rTMS) |
| Control group | Sham comparator | Procedure: Sham Repetitive transcranial magnetic stimulationThe Control group received rTMS with sham transcranial magnetic stimulation (sham-rTMS) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age≥18 years, < 60 years, both genders；
- Willing to participate and sign the informed consent；
- Bilateral temporal windows were well penetrated;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Hz Repetitive transcranial magnetic stimulationAfter enrollment, healthy adults received rTMS once a day (stimulation plan: stimulation of M1 region on the dominant hemisphere at 1Hz) | Procedure or surgery | Low-frequency rTMS Group |
| 10 Hz Repetitive transcranial magnetic stimulationAfter enrollment, healthy adults received rTMS once a day (stimulation plan: stimulation of M1 region on the dominant hemisphere at 10Hz) | Procedure or surgery | High-frequency rTMS Group |
| Sham Repetitive transcranial magnetic stimulationAfter 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 | Procedure or surgery | Control group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Hz Repetitive transcranial magnetic stimulation and 10 Hz Repetitive transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.