Transcranial Magnetic StimulationNCT05914623
Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
A study testing 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 was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transcranial Magnetic Stimulation
- What is being tested?
- 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2023to 1 Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, regardless of gender;
- Diagnosed with CSVD, and neuroimaging presented as recent small subcortical infarcts;
- Initiated transcranial magnetic stimulation within 7 days of onset;
- Subject or legal representative agreed to the treatment and signed the informed consent;
Who cannot join
- Vascular stenosis > 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;
- Previous history of atrial fibrillation or myocardial infarction within 6 months;
- Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;
- White matter hyperintensities (WMH) of non-vascular origin;
- Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;
- Patients with contraindications to transcranial magnetic stimulation, such as metal or electronic devices in the brain;
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- Pregnant or breastfeeding women;
- The patients with disorders of consciousness, agitation or insufficient bilateral temporal bone windows for insonation who cannot cooperate to dynamic cerebral autoregulation monitoring;
- Previous history of epilepsy or family history of epilepsy;
- Previous treatment with transcranial magnetic stimulation or its equivalent;
- Unwillingness to be followed up or poor adherence to treatment;
- Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study;
- Other conditions that the investigators deemed unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Yi Yang, MD,PhD, doctor_yangyi@163.com
About this study
The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.
Read the detailed description
Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with stroke. The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- Repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationProcedure or surgery
After enrollment, the patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).
Sham repetitive transcranial magnetic stimulationProcedure or surgery
After enrollment, the patients received sham-rTMS once a day for 5 consecutive days with the same parameters as the rTMS group, but the coil was rotated 90° away from the scalp.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Active comparator | Patients are treated with repetitive transcranial magnetic stimulation (rTMS). Receives: Procedure: Repetitive transcranial magnetic stimulation |
| sham-rTMS | Placebo comparator | Patients are treated with sham repetitive 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.
phase difference (PD) in degree
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: 0-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start25 Jun 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 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
- NCT05914623
- Sponsor's protocol ID
- TMSCA-CSVD
- Status last verified
- Feb 2024
- First submitted
- 6 Jun 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
- Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT05914623
- Acronym / sponsor ID
- TMSCA-CSVD
- Conditions
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 22 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 was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.
Detailed description
Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with stroke. The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Active comparator | Procedure: Repetitive transcranial magnetic stimulationPatients are treated with repetitive transcranial magnetic stimulation (rTMS). |
| sham-rTMS | Placebo comparator | Procedure: Sham repetitive transcranial magnetic stimulationPatients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years, regardless of gender;
- Diagnosed with CSVD, and neuroimaging presented as recent small subcortical infarcts;
- Initiated transcranial magnetic stimulation within 7 days of onset;
- Subject or legal representative agreed to the treatment and signed the informed consent;
Key exclusion criteria (13 listed)
- Vascular stenosis > 50% diagnosed by Transcranial Doppler (TCD) and carotid ultrasound;
- Previous history of atrial fibrillation or myocardial infarction within 6 months;
- Moyamoya disease or hereditary cerebral small vessel disease, such as CADASIL;
- White matter hyperintensities (WMH) of non-vascular origin;
- Severe hepatic and renal diseases, cancer or other major diseases related to integral medical and surgical procedures;
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationAfter enrollment, the patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz). | Procedure or surgery | rTMS |
| Sham repetitive transcranial magnetic stimulationAfter enrollment, the patients received sham-rTMS once a day for 5 consecutive days with the same parameters as the rTMS group, but the coil was rotated 90° away from the scalp. | Procedure or surgery | sham-rTMS |
Primary outcome
phase difference (PD) in degree
Time frame: 0-5 days
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.
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 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 4 inclusion and 13 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, MD,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?
phase difference (PD) in degree (time frame: 0-5 days). 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.