An interventional study of Transcranial stimulation in Down Syndrome, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Treatment
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Among 40 studies in Down Syndrome with a site in France — 12 open to participants now, 12 under way, none of them phase 3. Down Syndrome · France.
Among the 40 studies in Down Syndrome with a site in France, this one is the 12th largest by planned enrollment of the 17 interventional ones that give a count, is one of 5 that started in 2025, is one of 12 with no phase, reaches primary completion later than 5 of the 11 other live ones, and was the 34th registered.
439 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
Browse Down Syndrome studies →12 of the 40 studies in Down Syndrome with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 3–29 · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 5 mo–6 mo
Aelis Farma · Sites in France, Italy, Spain
Ages 16–32
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 3–12
University Hospital, Strasbourg, France · Sites in France
Ages 0–17
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 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 18 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.
40 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 1 · Phase 2 3 · Phase 3 2
First in 2000; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 62 is above the median of 38 across 287 interventional studies indexed under Down Syndrome.
Median enrollment 150 across the 17 interventional studies, 100 across the 23 observational. Of the 24 that completed or were terminated, 1 (4%) have results posted.
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7 of 40 have an industry lead sponsor. The 10 most frequent:
Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
Hôpital le Vinatier has 1 study filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Down Syndrome 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 |
|---|---|
| NCT06061562University Hospital, GrenobleDown Syndrome, Physical Activity and Sleep Apnea | 2026-12-31 |
| NCT05970965Assistance Publique - Hôpitaux de ParisPeriodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples | 2027-04-30 |
| NCT06866925Hôpital le VinatiertDCS for Catatonic Depression in Down Syndrome: A Pilot Study | 2027-08-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 40 studies in Down Syndrome with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study evaluates the efficacy of transcranial direct current stimulation (tDCS) for depression with catatonia in individuals with Down syndrome (DS). 62 patients will be randomized to receive 15 sessions of active or sham tDCS. The primary objective is to measure changes in depressive/catatonic symptoms using the Bush-Francis Catatonia Rating Scale (BFCRS). Secondary objectives include safety, cognitive effects, EEG correlates, and biological markers (cortisol, BDNF, cytokines). The study aims to provide a non-pharmacological therapeutic alternative for this population
Justification: Depression is common in individuals with Down syndrome (DS), often accompanied by catatonia, and is under-treated. Conventional treatments are limited by tolerability and linguistic difficulties. Transcranial direct current stimulation (tDCS), safe and effective, has never been tested in DS.
Hypothesis: tDCS is effective and safe for depression with catatonia in DS, improving mood, cognition, and motor symptoms.
Objectives:
Primary: To evaluate the clinical efficacy of 15 sessions of bifrontal tDCS on depression with catatonia in DS (Bush-Francis Catatonia Rating Scale (BFCRS)).
Secondary: To evaluate safety, long-term clinical and cognitive effects (1 and 3 months), EEG correlates, and biological effects (cortisol, BDNF, cytokines).
Methodology: Multicenter (2 sites), randomized, double-blind, placebo-controlled study. 30 DS patients will receive 15 sessions of active tDCS (2 mA, 20 min, anode over left DLPFC, cathode over right DLPFC) or sham tDCS.
Outcomes:
Primary: Changes in depressive/catatonic symptoms (BFCRS) between Day 0 and Day 5.
Secondary: Safety, clinical (MADRS, UPDRS), cognitive (SIB), EEG, and biological (blood, saliva) assessments.
Target Population: Men and women with DS with a depressive episode and catatonia (30 patients).
Inclusion Criteria: DS, age > 18 years, major depression with catatonia (DSM-5), informed consent.
Exclusion Criteria: Pregnancy, contraindication to tDCS, refusal. Statistical Analyses: ANOVA or mixed models for BFCRS scores. Justification for Inclusion: To provide a safe, non-pharmacological therapeutic alternative.
Withdrawal Criteria: Withdrawal of consent, severe pathology. Procedures: Clinical, cognitive, EEG, and biological (blood, saliva) assessments at Day 0, Day 1, Day 5, 1 and 3 months.
Recruitment: 6 sites (CH Vinatier Lyon, CHU Nantes, CHU Dijon, CHU Clermont Ferrand, CH Rouen, GHU Neurosciences Paris). EEG and biological analyses at Lyon and Paris only.
Number of Subjects: 62 patients (31 per group). Duration: Inclusion (24 months), individual participation (3 months), total study (27 months).
Locations: CH Le Vinatier (Lyon), CHU Nantes, CHU Dijon, CHU Clermont Ferrand, CH Rouen, GHU Neurosciences Paris.
Benefit-Risk Ratio: Pioneering study on tDCS in DS, aiming for a safe alternative to current treatments and a better understanding of neurobiological mechanisms.
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Group receiving 15 sessions of active tDCS (3 sessions per day for 5 days, from D0 to D5, with the tDCS anode placed over the left DLPFC and the cathode over the right DLPFC, located using the international 10/20 electrode placement system, each stimulation lasting 20 minutes at 2mA).
Device: Transcranial stimulation
Group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current).
Device: Transcranial stimulation
A randomized, 2-arm, sham-controlled study, patients with Down syndrome presenting with major depressive episode (DSM5) with catatonic features will be randomly allocated to receive 15 sessions of either active (20 min, 2mA, ramp up/down 30 sec) or sham tDCS (20 min, ramp up/down 30 sec at the beginning and at the end of each stimulation session), thrice daily. Each stimulation session will be spaced at least two hours apart. The anode will be placed over the left DLPFC, the cathode over the right DLPFC using the Beam F3 algorithm in order to individualize target location based on head circumference, tragus to tragus and inion to nasion distances.
Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS)
The primary outcome will be the acute changes in the severity of catatonic symptoms measured by the BFCRS evaluated before treatment (D0) and after the tDCS regimen (D5). The analyses will be performed on a strict intention-to-treat sample of the evaluable patients defined in the protocol as patients with a baseline assessment and at least one post-tDCS score.
Time frame: 27 months
Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects
Bush-Francis Catatonia Rating Scale (BFCRS)
Time frame: 27 months
Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 27 months
Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 27 months
Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects
Severe Impairment Battery scale (SIB)
Time frame: 27 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Aug 2027, 22 months after the start.
Of 163 non-industry interventional studies with no phase under Down Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 33. This study's planned 22 months is above that.
Counting every sponsor, half of 165 studies reached it within 11 months; a quarter within 3 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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