A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia
Recruiting · NCT06668610 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Campania Luigi Vanvitelli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- brain events with an acute aetiology (stroke, traumatic brain injury, neoplastic ablation);
- psychiatric disorders (schizophrenia, psychosis, bipolar disorder) and assumption of psychotropic drugs;
- diagnosis of moderate or severe major neurocognitive disorders (DSM-5; APA 2013) with CDR scores equal or above 2 (Morris, 1993);
- any condition with may also hypothetically interfere with electrophysiological recording and neurostimulation (metallic implants in the brain, cochlear implant, pacemakers, or suffering from epilepsy) (Antal et al., 2017; Bikson et al., 2016).
Where it is running
1 location listed.
- Department of Psychology, University of Campania "Luigi Vanvitelli" - Caserta, Italy, Italy