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

NCT06785948 | Recruiting

• 1 other identifier: MCL-tDCS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lewy Body Dementia; Lewy Body Dementia With Behavioral Disturbance; Burden, Caregiver; Lewy Body Disease; Dementia With Lewy Bodies

Keywords

Transcranial Direct-Current Stimulation (t-DCS); Brain stimulation; Psychotic symptoms; Caregiver burden

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in the composite score named "psychotic factor" at T1

  "psychotic factor" corresponds to the sum of the subscores of psychotic-like symptoms from the Neuropsychiatric Inventory (NPI), namely Delusions, Hallucination, and Agitation/Aggression.

  Baseline, Week 2

• Change from Baseline in the composite score named "psychotic factor" at T2

  "psychotic factor" corresponds to the sum of the subscores of psychotic-like symptoms of the Neuropsychiatric Inventory (NPI), namely Delusions, Hallucination, and Agitation/Aggression.

  Baseline, Week 10

Secondary Outcomes (14)

• Change from Baseline in the Neuropsychiatric Inventory (NPI) total score

  Baseline, Week 2, Week 10

• Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores

  Baseline, Week 2, Week 10

• Change from Baseline in the Zarit scale score

  Baseline, Week 2, Week 10

• Change from Baseline in the Trail Making Test (TMT) A&B performances

  Baseline, Week 2, Week 10

• Change from Baseline in the Quality of life questionnaire (Qol)

  Baseline, Week 2, Week 10

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Device: active-tDCS

Sham tDCS

SHAM COMPARATOR

Device: Sham-tDCS

Interventions

active-tDCS DEVICE

2mA stimulation (anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital). 10 sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).

Active tDCS

Sham-tDCS DEVICE

No intensity applied (anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital). 10 sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).

Sham tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association de Recherche Bibliographique pour les Neurosciences: lead
• Centre Hospitalier Princesse Grace: collaborator
• Association des Aidants et Malades à Corps de Lewy (A2MCL): collaborator

Study Sites (1)

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

Monaco, 98000, Monaco

RECRUITING

MeSH Terms

Conditions

Lewy Body Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Sandrine LOUCHART de la CHAPELLE, MD, PhD

  Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin POLET, PhD

CONTACT

99995599; kevin.polet@chpg.mc

Solange HESSE

CONTACT

99995599; solange.hesse@chpg.mc

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 21, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: the data will become available when summary data are published
• Access Criteria: We will not share our data publicly, but we may provide it upon reasonable request to the principal investigator or the central contact person.

Locations

MO (1)