Can a magnetic helmet boost your brain? new trial aims to find out
NCT ID NCT06579664
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether a non-invasive brain stimulation technique called iTBS can improve memory and thinking in people with cerebral small vessel disease, a common cause of cognitive decline. 58 adults aged 45-80 will receive either real or sham stimulation daily for 15 days. Researchers will measure changes in cognitive tests to see if the treatment is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intermittent theta burst stimulation (iTBS) — a non-invasive brain stimulation device
- What this could lead to
- If it works, this could offer a new, drug-free way to ease cognitive decline from small vessel disease, improving daily thinking and memory.
- What could go wrong
- This is a small, early-phase study (58 people) testing feasibility and safety. The effect may be modest or not last, and not everyone may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 45-80 years old, with no limitation on sex. 2. Clinical evidence of CVSD as evidenced by one or more of: * White matter hyperintensity with Fazekas score ≥2 * a lacunar stroke syndrome (e.g. pure motor stroke, pure sensory stroke, sensorimotor stroke, ataxic hemiparesis, or clumsy hand dysarthria syndrome) with a corresponding acute lacunar infarct on diffusion weighted imaging (DWl) for cases imaged (clinically) within 3 weeks of stroke or anatomically compatible lacunar infarct on fluid attenuated inversion recovery (FLAIR)/T1 MRI for cases imaged later after stroke (diameter≤1.5cm). 3. Independence of daily life (modified Rankin Scale score ≤2). 4. Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22. 5. Routine, consistent medication for 4 weeks or more. Exclusion Criteria: 1. History of stroke within previous 30 days, including cerebral infarction (diameter \>15mm), cerebral hemorrhage, subarachnoid hemorrhage; 2. History of cerebral cortex infarction. 3. History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm \> 3mm. 4. Carotid or vertebral artery stenosis \> 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. 5. Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB), cortical superficial siderosis, or convexal subarachnoid hemorrhage) measured on Boston Criteria 2.0; Or at least one lobar hemorrhagic lesion and at least one white matter feature (severe enlarged perivascular space in the centrum semiovale or multiple punctate white matter hyperintensities) without deep hemorrhagic lesion (cerebral hemorrhage or CMB) on T2\* weighted MRI. 6. Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease). 7. Definite non-vasogenic white matter lesions (e.g. multiple sclerosis, cortical dysplasia in adults, metabolic encephalopathy). 8. Other psychiatric disorders diagnosed measured on the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) diagnostic criteria; Or apparent suicidal intent. 9. Unable to tolerate MRI or contraindication to MRI (e.g., claustrophobia). 10. T1 or T2 weighted MRI shows focal brain injury. 11. Patients or first-degree relatives with a history of seizures. 12. Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or other metal medical devices. 13. Received transcranial magnetic stimulation therapy within previous 3 months. 14. Severe organic diseases with expected survival time \<5 years, such as malignant tumor. 15. Women of child bearing potential, pregnant or breastfeeding. 16. Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation. 17. Combined with alcohol and drug abuse history. 18. Unable to be cooperative and complete the follow-up due to geographical or other reasons. 19. Participated in other clinical trials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital
RECRUITINGBeijing, China
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