Magnetic pulses aim to stabilize the wandering mind in lewy body dementia

NCT ID NCT05138588

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

45 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, 67000, France