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A Multifocal TDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia
Sponsor: University of Campania Luigi Vanvitelli
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-10-01
Completion Date
2026-10-01
Last Updated
2024-10-31
Healthy Volunteers
No
Conditions
Interventions
StarStim 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.
StarStim 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.
Cognitive 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