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

September 30, 2025 updated by: Association de Recherche Bibliographique pour les Neurosciences

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Monaco
      • Monaco, Monaco, 98000
        • Recruiting
        • Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandrine LOUCHART DE LA CHAPELLE, MD-PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham tDCS
Device: Sham-tDCS

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).
Active Comparator: Active tDCS
Device: active-tDCS

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the composite score named "psychotic factor" at T1
Time Frame: Baseline, Week 2
"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
Time Frame: Baseline, Week 10
"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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Neuropsychiatric Inventory (NPI) total score
Time Frame: Baseline, Week 2, Week 10
Neuropsychiatric Inventory (NPI), a scale that includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). The evaluation was based on an interview with patients' primary caregivers. Both the frequency (/4) and the severity (/3) of each behavior were determined and a score was calculated by multiplying the frequency and the severity of each behavior observed.
Baseline, Week 2, Week 10
Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores
Time Frame: Baseline, Week 2, Week 10
Neuropsychiatric Inventory (NPI) scale includes ten behavioral items (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability and aberrant motor behaviors) and two neurovegetative symptoms (sleep and appetite disorders). For each behavior the frequency (/4) and the severity (/3) were determined, corresponding to a subscore.
Baseline, Week 2, Week 10
Change from Baseline in the Zarit scale score
Time Frame: Baseline, Week 2, Week 10
The burden of the family caregiver was measured with the Zarit burden interview scale (completed by the caregiver). Composed of 22 questions on the physical, emotional and financial load felt. Total score /88.
Baseline, Week 2, Week 10
Change from Baseline in the Trail Making Test (TMT) A&B performances
Time Frame: Baseline, Week 2, Week 10
The TMT A&B is a task requiring a subject to connect a sequence of 25 consecutive targets on a sheet of paper, in the shortest time possible without lifting the pen from the paper. Performances are time and number of errors
Baseline, Week 2, Week 10
Change from Baseline in the Quality of life questionnaire (Qol)
Time Frame: Baseline, Week 2, Week 10
QoL was measured using the 13-item Quality of Life in Alzheimer's Disease (QOL-AD) scale (total score range 13-52; higher scores indicate better QOL). The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks
Baseline, Week 2, Week 10
Change from Baseline in the Mayo Clinic fluctuations scales score
Time Frame: Baseline, Week 2, Week 10
The Mayo Fluctuations Scale is a four-item questionnaire assessing the common symptoms of cognitive fluctuation shown to significantly differentiate Lewy Body Dementia from Alzheimer disease. These four items are daytime drowsiness, daytime sleepiness, disorganised thought and staring spell. Total score /4.
Baseline, Week 2, Week 10
Change from Baseline in the percentage of errors during an "antisaccades" paradigm
Time Frame: Baseline, Week 2, Week 10
Eye movements were recorded and analyzed with an eye-tracking device.
Baseline, Week 2, Week 10
Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm
Time Frame: Baseline, Week 2, Week 10
Eye movements were recorded and analyzed with an eye-tracking device.
Baseline, Week 2, Week 10
Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades
Time Frame: Baseline, Week 2, Week 10
Eye movements are recorded and analyzed with an eye-tracking device. Mean measurement is calculated from several saccades latency recorded during voluntary saccades paradigm
Baseline, Week 2, Week 10
Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm
Time Frame: Baseline, Week 2, Week 10
Eye movements are recorded and analyzed with an eye-tracking device. Presence, absence, frequency (number/minute) of square wave-jerks are recorded.
Baseline, Week 2, Week 10
Change from Baseline in the frequency of fixations impairments during eye movements paradigm
Time Frame: Baseline, Week 2, Week 10
Eye movements are recorded and analyzed with an eye-tracking device. Presence, absence, frequency of nystagmus, flutters or other fixations impairments
Baseline, Week 2, Week 10
Change from Baseline in the saccades main velocity during oculomotor paradigms
Time Frame: Baseline, Week 2, Week 10
This concerns saccades Main velocity (in °/sec) during vertical and horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.
Baseline, Week 2, Week 10
Change from Baseline in the saccades gain during oculomotor paradigms
Time Frame: Baseline, Week 2, Week 10
This concerns saccades Gain (gaze accuracy) during vertical and horizontal paradigms. Gain range 0-1. Eye movements were recorded and analyzed with an eye-tracking device.
Baseline, Week 2, Week 10
Change from Baseline in the saccades latency during oculomotor paradigms
Time Frame: Baseline, Week 2, Week 10
This concerns saccades Latency (in ms) during vertical and horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.
Baseline, Week 2, Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association de Recherche Bibliographique pour les Neurosciences

Collaborators

Centre Hospitalier Princesse Grace
Association des Aidants et Malades à Corps de Lewy (A2MCL)

Investigators

  • Principal Investigator: Sandrine LOUCHART de la CHAPELLE, MD, PhD, Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 21, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCL-tDCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The specific individual participant data (IPD) sets to be shared would be all IPD that underlie results in a publication

IPD Sharing Time Frame

the data will become available when summary data are published

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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