Magnetic pulses aim to stabilize the wandering mind in lewy body dementia
NCT ID NCT05138588
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial tests whether personalized repetitive transcranial magnetic stimulation (rTMS) can reduce cognitive fluctuations—sudden changes in alertness and attention—in people with dementia with Lewy bodies (DLB). Forty participants will receive both an experimental rTMS condition targeting the insular cortex, a brain region linked to these fluctuations, and a control condition. The study uses brain imaging and EEG to measure changes in arousal and cognitive symptoms before and after stimulation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique using magnetic pulses to modulate brain activity.
- What this could lead to
- If effective, this could offer a non-invasive way to reduce the unpredictable swings in alertness and attention that disrupt daily life for people with Lewy body dementia.
- What could go wrong
- This is a small early-stage proof-of-concept study, so results may not hold up in larger trials. The effect on cognitive fluctuations is uncertain, and the stimulation may cause discomfort or other minor side effects.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Jul 2028
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 years and older
- 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: * Male or female patient aged ≥ 45 years * Enrolled in a social health insurance scheme * Diagnosed with probable DLB according to McKeith et al. criteria, 2017, or McKeith et al. 2020 criteria for the prodromal stage * A Mini Mental State Examination (MMSE; Folstein et al., 1983) score ≥ to 18 in the last 6 months (prodromal stage or a major neurocognitive disorder (dementia syndrome) at moderate stage) * MMSE score ≥ to 15 at the inclusion visit * Presence of clinically significant cognitive fluctuations * Caregivers of eligible patients do have to be able to stay with the patient for at least 4 hours a day, 3 days a week, and have to be able to provide requested information and accompany the patient to the certain visits. * The patient must be able to understand the objectives and risks of the study and has to be able to give dated and signed informed consent. In the case of a designed guardian or curator, the guardian or curator will sign the consent. * For women of childbearing age, effective contraception throughout the study is required Exclusion criteria: * History of generalized seizures (epilepsy) * Pharmacological treatment for cognitive fluctuations in DLB with dose modifications that have taken place less than 2 months before the first visit of the protocol (anticholinesterase and neuroleptics) * Anti-epileptic drug treatment "Keppra" (Levetiracetam) * History of psychosis or severe depression unrelated to DLB * History of brain surgery (tumour removal, electrode implantation, certain strokes as judged by the investigator, oedema...) * Patients with any contraindication for MRI scans (claustrophobia, pacemaker, cochlear implant, mechanical heart valve, metallic prostheses, neurostimulators, other non-removably implanted electronic medical devices etc.) * Subject unable to understand the aims and risks of the study and patients unable to give full informed consent * Having a MMSE score \< to 18 in the last 6 months (prodromal stage or mild to moderate dementia) * MMSE score \< to 15 at the inclusion visit * Patients in an emergency or life-threatening situation * Patients under court protection * Pregnancy * Breastfeeding * Patients in exclusion period (determined by a previous or current study)
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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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Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67000, France