Evaluating Multifocal Non-Invasive Brain Stimulation and Cognitive Training to Improve Symptoms in Mild Cognitive Impairment and Early Dementia
Led by University of Campania Luigi Vanvitelli · Updated on 2026-04-22
50
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
F
Francesco Panico, PhD
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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
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
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
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.