Lewy Body DementiaMCL-tDCSNCT06785948
tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
A study testing active-tDCS in people with Lewy Body Dementia and Lewy Body Dementia With Behavioral Disturbance, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lewy Body Dementia, Lewy Body Dementia With Behavioral Disturbance, Burden, Caregiver
- What is being tested?
- active-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteMonaco
- Study dates
- 10 Jan 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Monaco1 site
Clinical Research Unit-Memory Clinic / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital
Monaco, 98000
About this study
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?
Read more
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
- Being tested
- active-tDCS, Sham-tDCS
- Keywords
- Transcranial Direct-Current Stimulation (t-DCS), Brain stimulation, Psychotic symptoms, Caregiver burden
- Medical subject headings
- Lewy Body Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active-tDCSDevice
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).
Sham-tDCSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Not described Receives: Device: active-tDCS |
| Sham tDCS | Sham comparator | Not described Receives: Device: Sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 10
Secondary outcomes (14)
Change from Baseline in the Neuropsychiatric Inventory (NPI) total score
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.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores
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.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the Zarit scale score
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.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the Trail Making Test (TMT) A&B performances
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
Measured: Baseline, Week 2, Week 10
Change from Baseline in the Quality of life questionnaire (Qol)
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
Measured: Baseline, Week 2, Week 10
Change from Baseline in the Mayo Clinic fluctuations scales score
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.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the percentage of errors during an "antisaccades" paradigm
Eye movements were recorded and analyzed with an eye-tracking device.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the saccades latency (in ms) during an "antisaccades" paradigm
Eye movements were recorded and analyzed with an eye-tracking device.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades
Eye movements are recorded and analyzed with an eye-tracking device. Mean measurement is calculated from several saccades latency recorded during voluntary saccades paradigm
Measured: Baseline, Week 2, Week 10
Change from Baseline in the frequency of square waves-jerks during horizontal eye movements paradigm
Eye movements are recorded and analyzed with an eye-tracking device. Presence, absence, frequency (number/minute) of square wave-jerks are recorded.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the frequency of fixations impairments during eye movements paradigm
Eye movements are recorded and analyzed with an eye-tracking device. Presence, absence, frequency of nystagmus, flutters or other fixations impairments
Measured: Baseline, Week 2, Week 10
Change from Baseline in the saccades main velocity during oculomotor paradigms
This concerns saccades Main velocity (in °/sec) during vertical and horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the saccades gain during oculomotor paradigms
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.
Measured: Baseline, Week 2, Week 10
Change from Baseline in the saccades latency during oculomotor paradigms
This concerns saccades Latency (in ms) during vertical and horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device.
Measured: Baseline, Week 2, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start10 Jan 2025
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Bibliographique pour les Neurosciences
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Association des Aidants et Malades à Corps de Lewy (A2MCL)
- Responsible party
- Sponsor
- Investigators
- Sandrine LOUCHART de la CHAPELLE, MD, PhD, Principal investigator, Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785948
- Sponsor's protocol ID
- MCL-tDCS
- Acronym
- MCL-tDCS
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The specific individual participant data (IPD) sets to be shared would be all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden
- ClinicalTrials.gov ID
- NCT06785948
- Acronym / sponsor ID
- MCL-tDCS / MCL-tDCS
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Association de Recherche Bibliographique pour les NeurosciencesUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace, Association des Aidants et Malades à Corps de Lewy (A2MCL)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: active-tDCS |
| Sham tDCS | Sham comparator | Device: Sham-tDCS |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active-tDCS2mA 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). | Device | Active tDCS |
| Sham-tDCSNo 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). | Device | Sham tDCS |
Primary outcome
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.
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.
14 secondary outcomes
Change from Baseline in the Neuropsychiatric Inventory (NPI) total score
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Neuropsychiatric Inventory (NPI) subscores
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Zarit scale score
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Trail Making Test (TMT) A&B performances
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Quality of life questionnaire (Qol)
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the Mayo Clinic fluctuations scales score
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the percentage of errors during an "antisaccades" paradigm
Time frame: 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
Change from Baseline in the mean variation of latency times (in ms) during voluntary saccades
Time frame: 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
Change from Baseline in the frequency of fixations impairments during eye movements paradigm
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades main velocity during oculomotor paradigms
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades gain during oculomotor paradigms
Time frame: Baseline, Week 2, Week 10
Change from Baseline in the saccades latency during oculomotor paradigms
Time frame: Baseline, Week 2, Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. The specific individual participant data (IPD) sets to be shared would be all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine LOUCHART de la CHAPELLE, MD, PhD principal investigator
Memory Clinic and Gerontologic center, Princess Grace Hospital (MONACO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active-tDCS in people with Lewy Body Dementia and Lewy Body Dementia With Behavioral Disturbance, run by Association de Recherche Bibliographique pour les Neurosciences at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the composite score named "psychotic factor" at T1 (time frame: Baseline, Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.