Down SyndromeTOTORONCT06866925
tDCS for Catatonic Depression in Down Syndrome: A Pilot Study
A study testing Transcranial stimulation in people with Down Syndrome, run by Hôpital le Vinatier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Transcranial stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2025to 30 Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Down syndrome
- Age > 18
- Diagnosis of Major Depressive Disorder MDD with catatonic symptoms according to the DSM-5 criteria
- Informed consent signed by the patient, by the patient under curatorship, or by the legal representative in the case of a patient under guardianship.
- Person affiliated to the French social security system or equivalent
Who cannot join
- Pregnancy (checked with a pregnancy test)
- Contraindication for tDCS(i.e., cochlear implant)
- Refusal of the patients or their legal representatives
- Other persons protected under the CSP (judicial safeguard, family habilitation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678
DEMILY MD CAROLINE, PH, 0033437915163, caroline.demily@ch-le-vinatier.fr
VIAL VERONIQUE, 0033437915531, veronique.vial@ch-le-vinatier.fr
About this study
Official title: Transcranial Direct Current Stimulation as a Treatment for Depression With Catatonic Features in Patients With Down Syndrome: a Pilot Randomized Sham-controlled Study
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
Read the detailed description
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.
- Conditions
- Down Syndrome
- Being tested
- Transcranial stimulation
- Keywords
- catatonia
- Medical subject headings
- Down Syndrome, Catatonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | 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). Receives: Device: Transcranial stimulation |
| Sham tDCS | Placebo comparator | Group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current). Receives: Device: Transcranial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 27 months
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start12 Sep 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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
- Multicenter (6 sites), randomized, double-blind, parallel-group controlled study. Patients will be randomly assigned to a 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), or to a group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current). Participation in the EEG and biology component will be limited to the Lyon and Paris centers.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAROLINE C DEMILY, MD PhD HDR, Principal investigator, HOPITAL VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866925
- Sponsor's protocol ID
- 2024-A00452-45
- Other IDs
- PHRC-23-0027
- Acronym
- TOTORO
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2025
- Last updated
- 11 Jun 2026
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation as a Treatment for Depression With Catatonic Features in Patients With Down Syndrome: a Pilot Randomized Sham-controlled Study
- ClinicalTrials.gov ID
- NCT06866925
- Acronym / sponsor ID
- TOTORO / 2024-A00452-45
- Conditions
- Down Syndrome
- Keywords
- catatonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Mar 2025 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter (6 sites), randomized, double-blind, parallel-group controlled study. Patients will be randomly assigned to a 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), or to a group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current). Participation in the EEG and biology component will be limited to the Lyon and Paris centers.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Transcranial stimulationGroup 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). |
| Sham tDCS | Placebo comparator | Device: Transcranial stimulationGroup receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with Down syndrome
- Age > 18
- Diagnosis of Major Depressive Disorder MDD with catatonic symptoms according to the DSM-5 criteria
- Informed consent signed by the patient, by the patient under curatorship, or by the legal representative in the case of a patient under guardianship.
- Person affiliated to the French social security system or equivalent
Key exclusion criteria (4 listed)
- Pregnancy (checked with a pregnancy test)
- Contraindication for tDCS(i.e., cochlear implant)
- Refusal of the patients or their legal representatives
- Other persons protected under the CSP (judicial safeguard, family habilitation)
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 |
|---|---|---|
| Transcranial stimulationA 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. | Device | Active tDCS, Sham tDCS |
Primary outcome
Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS)
Time frame: 27 months
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.
4 secondary outcomes
Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects
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
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
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
Time frame: 27 months
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 11 Jun 2026.
- 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.
CAROLINE C DEMILY, MD PhD HDR principal investigator
HOPITAL VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial stimulation in people with Down Syndrome, run by Hôpital le Vinatier 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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?
Contact JEROME J BRUNELIN, PhD, HDR) (00334 37 91 54 95, jerome.brunelin@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS) (time frame: 27 months). 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 11 Jun 2026.