Actively Recruiting

Phase Not Applicable
Age: 55Years - 85Years
All Genders
ID06668610

An Integrated Multifocal tDCS-EEG Protocol for Improving Cognitive and Affective Symptoms in Mild Cognitive Impairment and Early Stages of Dementia: a Crossover Double-blind Randomised Controlled Trial

Led by University of Campania Luigi Vanvitelli · Updated on 2026-04-22

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a combined approach using multifocal non-invasive brain stimulation and brain recording with cognitive training can help reduce cognitive and emotional symptoms in people with mild cognitive impairment and early dementia. The study aims to understand if this treatment affects cognition and depression symptoms, and how factors like education and cognitive reserve influence outcomes. It also investigates brain activity measures to identify who responds best to the treatment. Participants will receive two treatment cycles involving either real or placebo multifocal transcranial direct current stimulation (tDCS) over the left frontal and temporal brain areas, twice a week for two months each cycle. Along with the brain stimulation, all participants will undergo cognitive training involving exercises targeting memory, attention, and executive functions. The study uses a crossover design where each participant experiences both real and placebo stimulation cycles. During the trial, participants will complete detailed cognitive and mood assessments before treatment and after each cycle, including tests like the Montreal Cognitive Assessment and Geriatric Depression Scale. EEG brain recordings will monitor brain activity at specific sessions. Caregivers will provide information on daily living activities. The study measures changes in cognition, mood, and functional independence over an 8-week intervention period with regular evaluations.

CONDITIONS

Brief Title

A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia

Who Can Participate

Age: 55Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 55 and 85 years
  • Diagnosis of mild or early stage neurocognitive disorder (minor or mild major neurocognitive disorder) according to DSM-5 with Clinical Dementia Rating Scale (CDR) of 0.5 or 1
  • Right-handedness
Not Eligible

You will not qualify if you...

  • History of acute brain events such as stroke, traumatic brain injury, or brain surgery
  • Presence of psychiatric disorders like schizophrenia, psychosis, or bipolar disorder and use of psychotropic drugs
  • Diagnosis of moderate or severe major neurocognitive disorder with CDR scores of 2 or higher
  • Conditions interfering with brain stimulation or recording, including metallic brain implants, cochlear implants, pacemakers, or epilepsy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks (two 4-week cycles)

Participants receive two cycles of multifocal transcranial direct current stimulation (tDCS) combined with cognitive stimulation therapy. Each cycle consists of 8 sessions of tDCS delivered twice a week over 4 weeks, followed by cognitive exercises targeting memory, attention, and executive functions.

Twice-weekly visits for each 4-week cycle, totaling 16 sessions

Follow-up

Duration - 1 week after treatment cycles

Participants undergo assessments to monitor cognitive and affective symptoms as well as brain activity after the treatment cycles.

Several assessments scheduled around weeks 0, 4, 5, and 8

Trial Site Locations

Total: 1 location

1

Department of Psychology, University of Campania "Luigi Vanvitelli"

Caserta, Italy, Italy, 81100

Actively Recruiting

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Research Team

F

Francesco Panico, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

An integrated multifocal tDCS-EEG protocol for reducing cognitive and affective symptoms in mild cognitive impairment and early stages of dementia: a crossover double-blind randomized controlled trial.

Laura Catalano, Laura Sagliano, Anna Visciglio...

https://pubmed.ncbi.nlm.nih.gov/40606130