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NCT Number: NCT06785948

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

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).

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Key information

Conditions

Lewy Body Dementia Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Burden, Caregiver Caregiver Burden Central Nervous System Diseases Dementia Dementia With Lewy Bodies Lewy Body Dementia With Behavioral Disturbance Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Stress, Psychological Synucleinopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Monaco, 98000

Location status: Recruiting

Location contact

Kevin POLET

CONTACT

[email protected]

Sandrine LOUCHART DE LA CHAPELLE, MD-PHD

PRINCIPAL_INVESTIGATOR

Solange HESSE

CONTACT

[email protected]

+377 99995599

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. 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.

  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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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

  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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin POLET, PhD

CONTACT

[email protected]

99995599 ext. 00377

Solange HESSE

CONTACT

[email protected]

99995599 ext. 00377

Sponsors and collaborators

Lead sponsor

Association de Recherche Bibliographique pour les Neurosciences

Other

Collaborators

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

Registry information

Acronym: MCL-tDCS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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