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

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.

Conditions

• Mild Cognitive Impairment (MCI)
• Dementia
• Alzheimer Disease, Early Onset
• Alzheimer Disease
• Frontotemporal Degeneration (FTD)
• Neurocognitive Decline

Interventions

DEVICE

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.

BEHAVIORAL

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) .

DEVICE

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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-10-01

Completion

2026-10-01

Countries

• Italy

Study Locations