A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Mild Cognitive Impairment (MCI), Dementia, Alzheimer Disease, Early Onset, Alzheimer Disease, Frontotemporal Degeneration (FTD), Neurocognitive Decline
In brief
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.
Key facts
- Study ID
- NCT06668610
- Run by
- University of Campania Luigi Vanvitelli
- People needed
- 50
- Starts
- 2024-10-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Department of Psychology, University of Campania "Luigi Vanvitelli" — Caserta, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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