NCT05138588 · RECRUITING
Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept
This trial tests whether repetitive transcranial magnetic stimulation, a non-invasive device that uses magnetic pulses on the scalp, can ease cognitive fluctuations in people with Dementia with Lewy Bodies. Researchers compare a real target, the insular cortex, against a control setting. It is an early proof-of-concept study with 40 people, not yet proven or approved.
You may qualify if
- 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
You're excluded if
- 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-08-20