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.
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.
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).
Crossover
StarStim 32, Neuroelectrics, Spain - Real multifocal tDCS
DeviceReal 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
DeviceSham 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
BehavioralDuring 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) .
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.
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.
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
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.
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.
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.
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.
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