RecruitingNot ApplicableNCT06668610

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

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


Sponsor

University of Campania Luigi Vanvitelli

Enrollment

50 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if an integrated protocol using multifocal non invasive brain stimulation and brain recording combined with cognitive training is effective in treating cognitive and affective symptomatology in patients with mild cognitive impairment and early stages of dementia. The main questions it aims to answer are: * Does multifocal non-invasive brain stimulation reduce cognitive and affective symptoms in patients with mild cognitive impairment and early stages of dementia? * Do some specific factors, such as education and cognitive reserve, affect the extent of the possible outcomes achievable from the intervention? * Do electrophysiological measures contribute identifying responders and non-responders to the treatment? Researchers will compare real non-invasive brain stimulation to a placebo stimulation (reproducing the same feeling of stimulation without actually stimulating the brain) combined with cognitive rehabilitation on general cognition measures and depression symptoms. Participants will * Undergo two treatment cycles (real stimulation or placebo over frontal and temporal ares of the left hemisphere) combined with cognitive training twice a week for two months. * Complete neuropsychological evaluations before the first rehabilitation cycle and at the end of each rehabilitation cycle. Caregivers will provide information on functional daily living activities for their relatives.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a brain stimulation approach called multifocal tDCS (transcranial direct current stimulation) — a non-invasive technique that delivers very low electrical current to specific brain areas — combined with EEG monitoring, to see if it can improve thinking and memory in people with mild cognitive impairment or early dementia. **You may be eligible if...** - You are between 55 and 85 years old - You have been diagnosed with mild cognitive impairment or early-stage dementia (CDR score of 0.5 or 1) - You are right-handed **You may NOT be eligible if...** - You have had a stroke, brain injury, or brain surgery - You have schizophrenia, bipolar disorder, or psychosis - You have moderate to severe dementia - You have a pacemaker, cochlear implant, metal implants in the brain, or epilepsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEStarStim 32, Neuroelectrics, Spain - Real multifocal tDCS

Real multifocal tDCS will be delivered with an intensity of 2.0 mA over 8 electrodes positioned over the frontal and temporal areas in the left hemisphere according to the international 10/10 EEG system. The overall duration of stimulation will be set at 20 minutes.

DEVICEStarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS

Sham multifocal tDCS will be delivered with an intensity of 2.0 mA over 8 electrodes positioned over the frontal and temporal areas in the left hemisphere according to the international 10/10 EEG system. The overall duration of stimulation will be set at 30 seconds.

BEHAVIORALCognitive treatment

During the two cycles, all participants will undergo traditional cognitive stimulation therapy, involving paper-and-pencil exercise and computerised activity on several cognitive domains including memory, attention, and executive functions (duration 30-40 minutes) .


Locations(1)

Department of Psychology, University of Campania "Luigi Vanvitelli"

Caserta, Italy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06668610


Related Trials