Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. There is growing interest for tDCS for psychiatric illnesses, notably for depression. Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. tDCS could be a promising new area for non-pharmacological treatment of apathy. The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders. For this, 30 apathetic subjects with minor neurocognitive disorders will be included and randomized between two groups. The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet. The control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions). Stimulation will be performed with Startim 20 (Neuroelectrics®) which is approved by the European Union as a Class IIa medical device and meeting European safety standards. Stimulation will last for 20 minutes and the dorsolateral prefrontal cortex (F3) will be targeted. For the intervention group, the electric current will be 2mA. Assessments will be done at baseline, just after the end of intervention and 3 months after intervention. Apathy, daily functional motor behaviors, cognitive functions and fatigue will be assessed with clinician assessment, self-administered questionnaires, ambulatory actigraphy and cognitive tests. The assessments and the intervention will be done by different people. Study will be a double-blind randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Centre Memoire Ressources et Recherche, CHU de Nice
Nice, France
Apathy Inventory (Robert et al., 2002), clinician version
The Apathy Inventory scored from 0 (No problem) to 4 (major problem) the 3 dimensions of apathy: the emotional blunting, the loss of initiative and the loss of interest. A higher total score indicates a greater severity.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of neuropsychiatric symptoms
Clinician assess behavioral symptoms and scored the severity from 0 to 3.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of the global cognitive functioning
Mini mental state examination (MMSE): test for asses the global cognitive functioning Unit of measure: score Scored from 0 to 30. A lower score indicate lower performance in global cognitive functioning.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of cognitive functions with FAB
Frontal assessment battery (FAB): test for asses global executive functions Unit of measure: score Scored from 0 to 18. A lower score indicate lower performance in global executive functions.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of episodic memory
Grober and Bruschke test : test for asses episodic memory Unit of measure: score Scored from 0 to 48. A lower score indicate lower performance in episodic memory
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of attention and mental flexibilty
Trail Making test A\_b: test for attention and mental flexibilty Unit of measure: time to realize the test A longer time indicate a lower performance in attention and mental flexibility.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of working memory
Empan de chiffres: test for asses working memory Unit of measure: score A lower score indicate a lower performance in working memory
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of verbal fluency
Fluency test: test for asses verbal fluency Unit of measure: number of words produced by the participant into 60 seconds A lower score indicate a lower performance.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of language
Test de "dénomination d'image": test for asses language Unit of measure: score A lower score indicate a lower performance.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of fatigue with Multidimensional fatigue inventory (MFI)
Multidimensional fatigue inventory (MFI): 20-item self-report questionnaire for measuring five dimensions of fatigue. Each subscale contains four items, which are scored on a five-point Likert-scale. Scores range from 4 (absence of fatigue) to 20 (maximum fatigue) for each subscale. Unit of measure: score
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of fatigue with 15-sec Sustained maximal handgrip contraction
15-sec Sustained maximal handgrip contraction: The decrease in force during the 15-s was used as the indicator of fatigability. Measure: performance for the test: The decrease in force during the 15-s was used as the indicator of fatigability. It was computed as the difference between the area under constant curve equal to the maximal grip force and the area under the force-time curve of 15-s
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of daily physical activity
Actigraphy: assessment of time physical activity of light, moderate and vigorous intensity and sedentary time in daily life in minute and % of daily activity.
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Assessment of tDCS adverse effects questionnaire
tDCS adverse effects questionnaire: questionnaire for asses the tDCS adverse effects. It is a 11-item scale. Each item corresponds to an adverse effect. Each item is scored from 1 (absence of the adverse effect) to 4 (severe). If the adverse effect is present (score\>1) the clinician scored if this is related to tdCS from 0 (none) to 5 (definite). A higher score indicate more adverse effects. Unit of measure: score
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.