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

View full record on ClinicalTrials.gov

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