tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden

Last updated: January 20, 2025
Sponsor: Association de Recherche Bibliographique pour les Neurosciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Lewy Body Dementia

Schizotypal Personality Disorder (Spd)

Alzheimer's Disease

Treatment

Sham-tDCS

active-tDCS

Clinical Study ID

NCT06785948
MCL-tDCS
  • Ages > 60
  • All Genders

Study Summary

The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are:

  • What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms?

  • What is the impact of tDCS on caregiver burden?

Researchers will compare active tDCS (2mA stimulation, anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital) to Sham tDCS (placebo stimulation, no intensity applied) to see if there is an effect on reducing psychotic-like symptoms and on caregiver burden.

Participants will:

  • Undergo a stimulation phase consisting of 10 tDCS sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).

  • perform assessments at T0 (inclusion), T1 (at the end of the stimulation phase), and T2 (follow-up at 8 weeks post stimulation).

Eligibility Criteria

Inclusion

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 cholinesteraseinhibitors, 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 thepsychotic-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

Exclusion Criteria:

  • History of alcoholism, drug addiction or neurological diseases such as brain trauma,epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which maylead to cognitive impairment,

  • Concomitant major psychiatric illness,

  • Significant physical illness or comorbidities

  • History of moderate to severe visual impairment secondary to glaucoma, cataract ormacular degeneration,

  • Patient under guardianship or curators

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Sham-tDCS
Phase:
Study Start date:
January 10, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital

    Monaco, 98000
    Monaco

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.