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

Study acronym: MCL-tDCS
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 2 of 2 entries Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 21 participants (planned 30)
    • Primary completion date changed from estimate of Nov 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 14 of 14 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06785948
Lead Sponsor Association de Recherche Bibliographique pour les Neurosciences
Collaborators: Centre Hospitalier Princesse Grace, Association des Aidants et Malades à Corps de Lewy (A2MCL)
Conditions
(from sponsor)		 Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance, Burden, Caregiver, Lewy Body Disease, Dementia With Lewy Bodies
Related terms Caregiver Burden, Lewy Body Disease
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov