Effects of t-DCS and Cognitive Training on Apathy in Elderly With Minor Neurocognitive Impairment
NCT ID: NCT05232877
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
27 participants
INTERVENTIONAL
2022-04-05
2026-06-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
he control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions).
TREATMENT
DOUBLE
Study Groups
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tDCS combined with simultaneous cognitive training
tDCS
The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet
cognitive training with a combined sham tDCS
SHAM tDCS
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).
Interventions
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SHAM tDCS
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).
tDCS
The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet
Eligibility Criteria
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Inclusion Criteria
* Subject consulting in one of the investigating centers
* Clinical diagnosis of Minor Neurocognitive Disorder according to DSM 5 criteria (APA, 2013)
* Apathetic syndrome defined according to the Diagnostic Criteria for Apathy (Miller \& al., 2021)
* Subject who can read and write French
* Subjects who are beneficiaries of a social security plan
* Signature of free and informed consent
Exclusion Criteria
* Known diagnosis of schizophrenia, bipolar disorder, substance abuse or dependence
* Significant sensory or motor impairment
* Subject under guardianship, conservatorship, or conservatorship
* Active smoking or smoking cessation of less than one year
* Contraindications to the practice of tDCS: history of intracranial hypertension, neurosurgery, metallic implant at the cephalic level, pacemaker
* Unbalanced epilepsy
* Severe somatic disease not stabilized
* Previous use of tDCS (problem of maintaining the integrity of the blinding procedure)
* Scalp skin disease
* Concurrent participation in another drug research study or any other study that may interfere with study results
65 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Eric ETTORE, MD
Role: PRINCIPAL_INVESTIGATOR
Nice University Hospital
Locations
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Centre Memoire Ressources et Recherche, CHU de Nice
Nice, , France
Countries
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Other Identifiers
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21-PP-15
Identifier Type: -
Identifier Source: org_study_id
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