Mild Cognitive Impairment (MCI)MuSt-MIDNCT06668610
A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia
A study testing StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS and Cognitive treatment in people with Mild Cognitive Impairment (MCI) and Dementia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Dementia, Alzheimer Disease, Early Onset
- What is being tested?
- StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS and Cognitive treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department of Psychology, University of Campania "Luigi Vanvitelli"
Caserta, Italy, 81100
Francesco Panico, PhD, 00390823275259, francesco.panico@unicampania.it
Laura Catalano, laura.catalano@unicampania.it
About this study
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
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.
Read more
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.
Read the detailed description
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
- Mild Cognitive Impairment (MCI), Dementia, Alzheimer Disease, Early Onset, Alzheimer Disease, Frontotemporal Degeneration (FTD), Neurocognitive Decline
- Being tested
- StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS, StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS, Cognitive treatment
- 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
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StarStim 32, Neuroelectrics, Spain - Real multifocal tDCSDevice
Also called transcranial Direct Current Stimulation
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 tDCSDevice
Also called transcranial Direct Current Stimulation
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 treatmentBehavioural
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) .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS; Device: StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS; Behavioral: Cognitive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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 data will be separated into two-second epochs after they are cleared of noise. Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform (FFT, Fast Fourier Transform). Maximum peaks will be determined in the delta (0.5-3.5 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (15-28 Hz) and gamma (28-48 Hz) frequency bands. These values will be used in statistical analysis for each person and electrode.
Measured: 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
Activities of Daily Living (ADL) Scale. The ADL refers to activities concerning care of one's own body, such as bathing, toileting, dressing and eating. The score ranges 0-6, with higher scores indicating higher levels of independence.
Measured: 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
Instrumental Activities of Daily Living (IADL) Scale. The IADL refers to activities to support daily life within the home and community, such as financial management, housekeeping, shopping for groceries, making telephone calls, and taking medication. The score ranges 0-8, with higher scores indicating higher levels of independence.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Trojano, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668610
- Sponsor's protocol ID
- Vanvitelli_DeptPsy_30/2024
- Acronym
- MuSt-MID
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40606130
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06668610
- Acronym / sponsor ID
- MuSt-MID / Vanvitelli_DeptPsy_30/2024
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| SHAM-REAL tDCS Group | Experimental | Device: StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS, Device: StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS, Behavioral: Cognitive treatmentParticipants 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. |
| REAL-SHAM tDCS Group | Experimental | Device: StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS, Device: StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCS, Behavioral: Cognitive treatmentParticipants 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StarStim 32, Neuroelectrics, Spain - Real multifocal tDCSAlso: transcranial Direct Current StimulationReal 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. | Device | REAL-SHAM tDCS Group, SHAM-REAL tDCS Group |
| StarStim 32, Neuroelectrics, Spain - Sham multifocal tDCSAlso: transcranial Direct Current StimulationSham 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. | Device | REAL-SHAM tDCS Group, SHAM-REAL tDCS Group |
| Cognitive treatmentDuring 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) . | Behavioural | REAL-SHAM tDCS Group, SHAM-REAL tDCS Group |
Primary outcome
Montreal Cognitive Assessment (MOCA; Santangelo et al., 2015).
Time frame: 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.
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.
Frontal Assessment Battery (FAB; Appollonio et al., 2005).
Time frame: 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.
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.
Free and Cued Selective Reminding Test (FCSRT; Frasson et al., 2011).
Time frame: 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.
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
Stroop Colour and Word Test (Caffarra et al., 2002).
Time frame: 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.
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.
Geriatric Depression Scale (GDS; Galeoto et al., 2018).
Time frame: 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.
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.
3 secondary outcomes
EEG Power Spectrum
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 40606130Catalano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS and Cognitive treatment in people with Mild Cognitive Impairment (MCI) and Dementia, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Panico, PhD (00390823275259, francesco.panico@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MOCA; Santangelo et al., 2015). (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06668610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.