An interventional study of SHAM tDCS and tDCS in Apathy and Neurocognitive Disorders, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment
Among 43 studies in Neurocognitive Disorders with a site in France — 20 open to participants now, 23 under way, none of them phase 3. Neurocognitive Disorders · France.
Among the 43 studies in Neurocognitive Disorders with a site in France, this one is the 21st largest by enrollment of the 24 interventional ones that give a count, is one of 8 that started in 2022, is one of 13 with no phase, reaches primary completion later than 4 of the 22 other live ones, and was the 19th registered.
274 studies on the registry are indexed under Neurocognitive Disorders; 90 are open to participants now.
Browse Neurocognitive Disorders studies →20 of the 43 studies in Neurocognitive Disorders with a site in France are open now. Recruiting first, the newest first:
KompanionCare SAS · Sites in France
Ages 60+
MapLight Therapeutics · Sites in France, United States, Argentina and 12 more countries
Ages 55–90
University Hospital, Grenoble · Sites in France
Ages 60+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 60+
Hospices Civils de Lyon · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 60 Neurocognitive Disorders studies recruiting now, 37 (62%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8 · Phase 3 3
First in 2011; this study’s year is marked. 8 started in 2022.
This study's enrollment of 27 is below the median of 80 across 175 interventional studies indexed under Neurocognitive Disorders.
Median enrollment 58 across the 24 interventional studies, 135 across the 19 observational. Of the 17 that completed or were terminated, 6 (35%) have results posted.
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11 of 43 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Centre Hospitalier Universitaire de Nice has 6 studies filed under Neurocognitive Disorders — fewer than ten, so there is no comparison to draw.
8 of the studies in Neurocognitive Disorders with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07237009KompanionCare SASEffects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders | 2026-12 |
| NCT05586672Etablissement Public de Santé Barthélemy DurandHR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD | 2027-01-31 |
| NCT07468305Centre Hospitalier Universitaire de NiceSENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: a Pilot Study | 2027-02 |
| NCT05129150University Hospital, ToursCognitive Disorders and Brain Pulse | 2027-03 |
| NCT06801171Centre Hospitalier Universitaire de NiceA Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders | 2027-05-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 43 studies in Neurocognitive Disorders with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: tDCS
Other: 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).
The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet
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.
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 neuropsychiatric symptoms
Clinician assess behavioral symptoms and scored the severity from 0 to 3.
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
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.
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
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.
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
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
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
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.
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
Empan de chiffres: test for asses working memory Unit of measure: score A lower score indicate a lower performance in 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
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.
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
Test de "dénomination d'image": test for asses language Unit of measure: score A lower score indicate a lower performance.
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)
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
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
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
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
Actigraphy: assessment of time physical activity of light, moderate and vigorous intensity and sedentary time in daily life in minute and % of daily 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
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
Time frame: Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Plan to share: No
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Ran from Apr 2022 to primary completion in Apr 2025, 35 months.
Of 80 non-industry interventional studies with no phase under Neurocognitive Disorders, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's 35 months is close to that.
Counting every sponsor, half of 83 studies reached it within 32 months; a quarter within 17 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice →