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Active Not RecruitingNCT05232877

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERSHAM tDCSThe control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions).
OTHERtDCSThe intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet

Timeline

Start date
2022-04-05
Primary completion
2025-04-04
Completion
2026-06-10
First posted
2022-02-10
Last updated
2025-11-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05232877. Inclusion in this directory is not an endorsement.