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Search / Trial NCT06668610

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

Launched by UNIVERSITY OF CAMPANIA LUIGI VANVITELLI · Oct 30, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Non Invasive Brain Stimulation (Nibs) Transcranial Direct Current Stimulation (T Dcs) Electroencephalography (Eeg) Crossover Randomised Controlled Trial Mild Cognitive Impairment Early Stage Dementia Multifocal Brain Stimulation

ClinConnect Summary

This clinical trial is looking at a new way to help people with mild cognitive impairment (MCI) and early stages of dementia, including Alzheimer’s disease. Researchers want to find out if a method called multifocal non-invasive brain stimulation—where gentle electrical stimulation is applied to the brain without any surgery—combined with cognitive training can reduce problems with thinking and mood. They will also explore if certain factors, like a person’s education level, can influence how well this treatment works.

To participate, individuals should be between 55 and 85 years old and diagnosed with either mild MCI or early-stage dementia. They must also be right-handed. Participants will take part in two treatment cycles, receiving either the real stimulation or a placebo (which feels the same but doesn’t actually stimulate the brain) along with cognitive training sessions twice a week for two months. Throughout the trial, participants will undergo assessments to measure their cognitive abilities and mood, and caregivers will help by providing information about daily activities. This study is currently recruiting participants, so if you or a loved one meets the criteria, it could be an opportunity to contribute to important research in this area.

Gender

ALL

Eligibility 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).

About University Of Campania Luigi Vanvitelli

The University of Campania Luigi Vanvitelli is a distinguished academic institution located in Italy, renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive expertise in biomedical sciences to conduct innovative studies that address critical health challenges. With a focus on ethical standards and patient safety, the university collaborates with various healthcare professionals and research entities to facilitate groundbreaking clinical investigations, ultimately contributing to the development of new therapies and enhancing medical knowledge.

Locations

Caserta, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported