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

NCT05232877 | Active Not Recruiting

• 1 other identifier: 21-PP-15
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apathy; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)

Secondary Outcomes (12)

• Assessment of neuropsychiatric symptoms

  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

  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

  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

  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

  Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)

Study Arms (2)

tDCS combined with simultaneous cognitive training

EXPERIMENTAL

Other: tDCS

cognitive training with a combined sham tDCS

SHAM COMPARATOR

Other: SHAM tDCS

Interventions

SHAM tDCS OTHER

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).

cognitive training with a combined sham tDCS

tDCS OTHER

The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet

tDCS combined with simultaneous cognitive training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• 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

You may not qualify if:

• Current clinical diagnosis of a depressive episode characterized by DSM 5 criteria (APA, 2013)
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Centre Memoire Ressources et Recherche, CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Lethargy; Neurocognitive Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Eric ETTORE, MD

  Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet. 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).

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: February 10, 2022
• Study Start: April 5, 2022
• Primary Completion: April 4, 2025
• Study Completion (Estimated): June 10, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)