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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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) .

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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