tDCS to reduce psychotic symptoms and caregiver burden in Lewy body dementia
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
We will try short, painless sessions of tDCS over two weeks in people over 60 with moderate Lewy body dementia to see if it reduces hallucinations and lowers caregiver stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Association de Recherche Bibliographique pour les Neurosciences Academic / other |
| Locations | 1 site (Monaco) |
| Trial ID | NCT06785948 on ClinicalTrials.gov |
What this trial studies
This pilot randomized study compares active transcranial direct-current stimulation (2 mA, anode on left dorsolateral prefrontal cortex, cathode on right fronto-orbital) to sham stimulation. Participants receive 10 sessions of 20 minutes each across two consecutive weeks and are assessed at baseline, at the end of stimulation, and at an 8-week follow-up. Primary outcomes focus on psychotic-like neuropsychiatric symptoms (NPI psychotic sub-scores) and caregiver burden. Eligible participants are adults over 60 with moderate DLB, MMSE > 15, and stable medications.
Who should consider this trial
Good fit: Adults over 60 with a moderate Lewy body dementia diagnosis, MMSE > 15, a positive NPI psychotic score, a family caregiver, and stable relevant medications for at least one month.
Not a fit: People with major psychiatric illness, significant medical comorbidities, a history of epilepsy or recent brain injury, or more severe dementia (MMSE ≤ 15) may not benefit or are excluded.
Why it matters
Potential benefit: If successful, this could offer a low-risk, non-drug option to reduce psychotic symptoms and ease caregiver burden in people with Lewy body dementia.
How similar studies have performed: Small studies of tDCS in other dementias and neuropsychiatric symptoms have shown mixed but sometimes promising results, while application specifically to DLB psychosis is limited and largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or Female, aged over 60, * Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria * No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion, * Mini Mental State Examination (MMSE) \> 15, * Composite score called "psychotic factor" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI \[12\]) greater than 0, * Presence of a family caregiver, * Sufficient written and oral expression in French, * Written informed consent signed by the patient and his/her family caregiver Exclusion Criteria: * History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment, * Concomitant major psychiatric illness, * Significant physical illness or comorbidities * History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration, * Patient under guardianship or curators
Where this trial is running
Monaco
- Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital — Monaco, Monaco (Recruiting)
Study contacts
- Principal investigator: Sandrine LOUCHART de la CHAPELLE, MD, PhD — Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)
- Study coordinator: Kevin POLET, PhD
- Email: kevin.polet@chpg.mc
- Phone: 99995599
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.