Improving symptoms of mild cognitive impairment and early dementia with brain stimulation
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
NA · University of Campania Luigi Vanvitelli · NCT06668610
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli (other) |
| Locations | 1 site (Caserta, Italy) |
| Trial ID | NCT06668610 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 55 to 85 with a diagnosis of mild cognitive impairment or early-stage dementia.
Not a fit: Patients with moderate to severe dementia or those with acute brain events or psychiatric disorders may not benefit from this study.
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 performed: Previous studies have shown promise with non-invasive brain stimulation techniques, but this multifocal approach combined with cognitive training is relatively novel.
Eligibility criteria
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 this trial is running
Caserta, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Cognitive Impairment, Dementia, Alzheimer Disease, Early Onset, Alzheimer Disease, Frontotemporal Degeneration, Neurocognitive Decline, non invasive brain stimulation, transcranial direct current stimulation