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

NCT06668610 | Recruiting

• 1 other identifier: Vanvitelli_DeptPsy_30/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI); Dementia; Alzheimer Disease, Early Onset; Alzheimer Disease; Frontotemporal Degeneration (FTD); Neurocognitive Decline

Keywords

non invasive brain stimulation (NIBS); transcranial direct current stimulation (tDCS); electroencephalography (EEG); crossover; randomised controlled trial; mild cognitive impairment; early stage dementia; multifocal brain stimulation

Outcome Measures

Primary Outcomes (5)

• Montreal Cognitive Assessment (MOCA; Santangelo et al., 2015).

  MOCA is a brief neuropsychological tool for screening global cognitive functioning specifically designed for MCI and early stages of dementia. The score ranges 0-30; the higher the score the higher the level of general cognitive functioning.

  The test will be used to monitor cognitive functions before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. Each cycle is 28 days.

• Frontal Assessment Battery (FAB; Appollonio et al., 2005).

  FAB is a screening neuropsychological battery for evaluation of executive functioning. Total score ranges 0-18; the higher the score, the higher the level of executive functioning.

  The test will be used to monitor cognitive functions before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. Each cycle is 28 days.

• Free and Cued Selective Reminding Test (FCSRT; Frasson et al., 2011).

  FCSRT is a neuropsychological tool designed to assess episodic memory domain. The test provides separate scores for free, cued and total immediate recall (scores 0-36), and scores for free, cued and total delayed recall (scores 0-12); the higher the scores, the higher the memory performance

  The test will be used to monitor cognitive functions before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. Each cycle is 28 days.

• Stroop Colour and Word Test (Caffarra et al., 2002).

  The Stroop Test is a neuropsychological test assessing cognitive interference and inhibition. The test provides two measures, i.e. overall number of errors and time to complete the test, with lower scores indicating better performance.

  The test will be used to monitor cognitive functions before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. Each cycle is 28 days.

• Geriatric Depression Scale (GDS; Galeoto et al., 2018).

  GDS is an evaluation tool to diagnose older adult's depression. This questionnaire is designed for the older person and defines his/her degree of satisfaction, quality of life, and feelings. The total score ranges 0-30 with higher scores indicating higher levels of depression.

  The test will be used to monitor affective symptoms before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. Each cycle is 28 days.

Secondary Outcomes (3)

• EEG Power Spectrum

  EEG recordings will be performed before and after the first (at week 0), eight (at week 4), ninth (at week 5) and sixtheenth (at week 8) intervention sessions. The scale will be completed by caregivers. Each intervention cycle is 28 days.

• Independence in Everyday Life - ADL

  The scale will be used to monitor symptoms before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. The scale will be completed by caregivers. Each cycle is 28 days.

• Independence in Everyday Life - IADL

  The scale will be used to monitor independence before the first cycle (T1, at week 0) and at the end of the first (T2; at week 4) and second cycle (T3; at week 8) of the intervention. The scale will be completed by caregivers. Each cycle is 28 days.

Study Arms (2)

SHAM-REAL tDCS Group

EXPERIMENTAL

Participants randomly assigned to this group will receive a first cycle of SHAM multifocal tDCS (8 sessions, twice a week) and a second cycle of REAL multifocal tDCS (8 sessions, twice a week). During both cycles participant will receive cognitive stimulation treatment after brain simulation.

Device: StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS; Device: StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS; Behavioral: Cognitive treatment

REAL-SHAM tDCS Group

EXPERIMENTAL

Participants randomly assigned to this group will receive a first cycle of REAL multifocal tDCS (8 sessions, twice a week) and a second cycle of SHAM multifocal tDCS (8 sessions, twice a week). During the two cycles participant will receive cognitive stimulation treatment after brain simulation.

Device: StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS; Device: StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS; Behavioral: Cognitive treatment

Interventions

StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS DEVICE

Real multifocal tDCS will be delivered with an intensity of 2.0 mA over 8 electrodes positioned over the frontal and temporal areas in the left hemisphere according to the international 10/10 EEG system. The overall duration of stimulation will be set at 20 minutes.

Also known as: transcranial Direct Current Stimulation

REAL-SHAM tDCS Group; SHAM-REAL tDCS Group

StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS DEVICE

Sham multifocal tDCS will be delivered with an intensity of 2.0 mA over 8 electrodes positioned over the frontal and temporal areas in the left hemisphere according to the international 10/10 EEG system. The overall duration of stimulation will be set at 30 seconds.

Also known as: transcranial Direct Current Stimulation

REAL-SHAM tDCS Group; SHAM-REAL tDCS Group

Cognitive treatment BEHAVIORAL

During the two cycles, all participants will undergo traditional cognitive stimulation therapy, involving paper-and-pencil exercise and computerised activity on several cognitive domains including memory, attention, and executive functions (duration 30-40 minutes) .

REAL-SHAM tDCS Group; SHAM-REAL tDCS Group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Department of Psychology, University of Campania "Luigi Vanvitelli"

Caserta, Italy, 81100, Italy

RECRUITING

Related Publications (1)

• Catalano L, Sagliano L, Visciglio A, Russo P, Miniello S, Trojano L, Panico F. An integrated multifocal tDCS-EEG protocol for reducing cognitive and affective symptoms in mild cognitive impairment and early stages of dementia: a crossover double-blind randomized controlled trial. Front Neurol. 2025 Jun 18;16:1605970. doi: 10.3389/fneur.2025.1605970. eCollection 2025.

  PMID: 40606130 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Francesco Panico, PhD

CONTACT

00390823275259; francesco.panico@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will adopt a double-blinded crossover randomised controlled design. The whole intervention will consist of two treatment phases (sham vs real multifocal stimulation) and multiple assessment phases performed before and after each rehabilitation cycle (T1, T2, T3). Recruited participants will be randomly assigned to a "SHAM-REAL" stimulation group or a "REAL-SHAM" stimulation group by computer-generated random numbers. Throughout the entirety of the study, all participants will undergo conventional cognitive stimulation therapy, involving paper-and-pencil exercise and computerised activity on several cognitive domains including memory, attention, and executive functions (Bahar-Fuchs et al., 2019; Woods et al., 2012).

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)