Personalized rTMS for cognitive fluctuations in Dementia With Lewy Bodies
Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept
NA · University Hospital, Strasbourg, France · NCT05138588
This study is testing if a special brain treatment can help people with Dementia with Lewy Bodies who have trouble with their thinking and memory.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05138588 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients diagnosed with Dementia with Lewy Bodies (DLB) who experience significant cognitive fluctuations. The study will involve 40 participants and will compare two different rTMS conditions in a randomized, crossover, double-blind design. The focus is on targeting the insular cortex, which is believed to play a role in cognitive instability in DLB. The trial will assess clinical outcomes related to cognitive fluctuations and the potential of the insular cortex as a biomarker for treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 and older diagnosed with probable DLB and experiencing clinically significant cognitive fluctuations.
Not a fit: Patients with mild cognitive impairment or other forms of dementia not related to DLB may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of cognitive fluctuations in patients with DLB, enhancing their quality of life.
How similar studies have performed: While the use of rTMS in dementia is an emerging field, similar studies have shown promise in targeting cognitive symptoms, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Strasbourg
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (RECRUITING)
Study contacts
- Principal investigator: Frédéric BLANC — Hôpitaux Universitaires de Strasbourg
- Study coordinator: Fréderic BLANC
- Email: f.blanc@unistra.fr
- Phone: 03 88 11 58 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dementia With Lewy Bodies Diagnosis, Significant Cognitive Fluctuations in DLB, rTMS, arousal, DLB, fluctuations, insula