Effects of t-DCS and Cognitive Training on Apathy in Elderly With Minor Neurocognitive Impairment — FAME3  

Neurocognitive Disorders Clinical Trial

Official title: Effects of t-DCS Combined With Concurrent Cognitive Training on Apathy in Elderly Subjects With Minor Neurocognitive Impairment

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Apathy
• Neurocognitive Disorders

• NCT number: NCT05232877
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nice
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 5, 2022
• Completion date: October 4, 2025