Improving symptoms of mild cognitive impairment and early dementia with brain stimulation
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
Run by University of Campania Luigi Vanvitelli · NCT06668610 · Data updated 2026-11-12
This study is testing a new brain stimulation treatment combined with mental exercises to see if it can help people with mild cognitive impairment and early dementia feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 85 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Caserta, Italy) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT06668610 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 55 to 85 with a diagnosis of mild cognitive impairment or early-stage dementia.
✕Probably not a fit
Patients with moderate to severe dementia or those with acute brain events or psychiatric disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a multifocal non-invasive brain stimulation protocol combined with cognitive training for patients with mild cognitive impairment and early stages of dementia. The study will compare real brain stimulation to a placebo stimulation while assessing cognitive and affective symptoms. Additionally, it will explore how factors like education and cognitive reserve influence treatment outcomes and utilize EEG to identify responders to the intervention. The goal is to develop effective non-pharmacological strategies for managing dementia symptoms.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-drug treatment option to alleviate cognitive and emotional symptoms in patients with mild cognitive impairment and early dementia.
How similar studies have gone: Previous studies have shown promise with non-invasive brain stimulation techniques, but this multifocal approach combined with cognitive training is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Department of Psychology, University of Campania "Luigi Vanvitelli"
Caserta, Italy, Italy Recruiting
Study contacts
- Study coordinator: Francesco Panico, PhD
- Email: francesco.panico@unicampania.it
- Phone: 00390823275259
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.