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

NCT ID: NCT06668610

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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The global prevalence of dementia is expected to continue to rise. Recent estimates forecast that the number of people with dementia worldwide will increase to 152 million cases in 2050. This calls for the development of effective prevention and treatment strategies. Recently, the benefits of non-pharmacological interventions for the intervention in dementia and its preclinical conditions are being explored. Within this contex, transcranial direct current stimulation (tDCS), represents a safe and straightforward approach to modulate brain excitability with the potential to reduce symptomatology in individuals with dementia and Mild Cognitive Impairment (MCI).

The objective of this study is to evaluate a protocol for the treatment of the cognitive and affective symptoms in dementia and MCI with several specific novel features.

First, the protocol adopts multifocal stimulation of relevant brain structures involved in the genesis of the symptoms. While previous studies focused on specific areas in the frontal and temporal cortex in separate treatment conditions, the present study employes multifocal tDCS over such structures to strengthen distribution of direct current over the left fronto-temporal network, and to possibly boost the achievable outcomes.

Second, to address the issue of heterogeneity of stimulation effects, the study combines electrophysiological measures (EEG) with brain stimulation to monitor the effect of brain stimulation following specific polarities, also considering possible individual differences in response to stimulation. Such a protocol would allow identifying responders (and non responders) to stimulation, thus targeting individuals which may benefit (or not) from a given intervention.

Third, the study will further explore the variability in response to brain stimulation raised by previous studies, considering the relationship between some demographic and psychological factors with clinical and electrophysiological outcomes. Previous studies have shown a buffering effect of age and education on global cognitive response following brain stimulation, and a relevant association of cognitive functioning with cognitive reserve. The contribution of these variables will be explored in the study to provide a more complex interpretation of either positive or null effects associated with the intervention.

Conditions

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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SHAM-REAL tDCS Group

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.

Group Type EXPERIMENTAL

StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS

Intervention Type 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.

StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS

Intervention Type 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.

Cognitive treatment

Intervention Type 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

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.

Group Type EXPERIMENTAL

StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS

Intervention Type 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.

StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS

Intervention Type 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.

Cognitive treatment

Intervention Type 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) .

Interventions

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StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS

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.

Intervention Type DEVICE

StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS

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.

Intervention Type DEVICE

Cognitive treatment

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) .

Intervention Type BEHAVIORAL

Other Intervention Names

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transcranial Direct Current Stimulation transcranial Direct Current Stimulation

Eligibility Criteria

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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).
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Luigi Trojano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychology, University of Campania "Luigi Vanvitelli"

Caserta, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Panico, PhD

Role: CONTACT

Phone: 00390823275259

Email: [email protected]

Facility Contacts

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Francesco Panico, PhD

Role: primary

Laura Catalano

Role: backup

Francesco Panico, PhD

Role: backup

Laura Catalano, PhD student

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40606130 (View on PubMed)

Other Identifiers

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Vanvitelli_DeptPsy_30/2024

Identifier Type: -

Identifier Source: org_study_id