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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• age between 55 and 85 years;

• diagnosis of minor neurocognitive disorder, or major neurocognitive disorder with mild severity, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5; APA 2013) with a Clinical Dementia Rating Scale (CDR) of .05 or 1 (Morris, 1993);

• right handedness.

Locations
Other Locations
Italy
Department of Psychology, University of Campania Luigi Vanvitelli
RECRUITING
Caserta
Contact Information
Primary
Francesco Panico, PhD
francesco.panico@unicampania.it
00390823275259
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 50
Treatments
Experimental: SHAM-REAL tDCS Group
Participants randomly assigned to this group will receive a first cycle of SHAM multifocal tDCS (8 sessions, twice a week) and a second cycle of REAL multifocal tDCS (8 sessions, twice a week). During both cycles participant will receive cognitive stimulation treatment after brain simulation.
Experimental: REAL-SHAM tDCS Group
Participants randomly assigned to this group will receive a first cycle of REAL multifocal tDCS (8 sessions, twice a week) and a second cycle of SHAM multifocal tDCS (8 sessions, twice a week). During the two cycles participant will receive cognitive stimulation treatment after brain simulation.
Sponsors
Leads: University of Campania Luigi Vanvitelli

This content was sourced from clinicaltrials.gov