ApathyFAME3NCT05232877
Effects of t-DCS and Cognitive Training on Apathy in Elderly With Minor Neurocognitive Impairment
A study testing tDCS in people with Apathy and Neurocognitive Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Apathy, Neurocognitive Disorders
- What is being tested?
- tDCS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2022to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of t-DCS Combined With Concurrent Cognitive Training on Apathy in Elderly Subjects With Minor Neurocognitive Impairment
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.
Read the 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
- Apathy, Neurocognitive Disorders
- Being tested
- SHAM tDCS, tDCS
- Medical subject headings
- Lethargy, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAM tDCSOther
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).
tDCSOther
The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet
| Study group | Role | What they receive |
|---|---|---|
| tDCS combined with simultaneous cognitive training | Experimental | Not described Receives: Other: tDCS |
| cognitive training with a combined sham tDCS | Sham comparator | Not described Receives: Other: SHAM tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Clinician assess behavioral symptoms and scored the severity from 0 to 3.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start5 Apr 2022
- Primary completion4 Apr 2025
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric ETTORE, MD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232877
- Sponsor's protocol ID
- 21-PP-15
- Acronym
- FAME3
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2021
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of t-DCS Combined With Concurrent Cognitive Training on Apathy in Elderly Subjects With Minor Neurocognitive Impairment
- ClinicalTrials.gov ID
- NCT05232877
- Acronym / sponsor ID
- FAME3 / 21-PP-15
- Conditions
- Apathy, Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| tDCS combined with simultaneous cognitive training | Experimental | Other: tDCS |
| cognitive training with a combined sham tDCS | Sham comparator | Other: SHAM tDCS |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAM 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). | Other | cognitive training with a combined sham tDCS |
| tDCSThe intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet | Other | tDCS combined with simultaneous cognitive training |
Primary outcome
Apathy Inventory (Robert et al., 2002), clinician version
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
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.
12 secondary outcomes
Assessment of neuropsychiatric symptoms
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
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
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
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
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
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
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
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)
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
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
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
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric ETTORE, MD principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Apathy and Neurocognitive Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy Inventory (Robert et al., 2002), clinician version (time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.