tDCS for Catatonic Depression in Down Syndrome: A Pilot Study
Key facts
- Who runs it
- Hôpital le Vinatier
- Where
- Lyon, FranceSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 62 people, planned
- Started
- 12 Sept 2025
- Expected to end
- 30 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Transcranial stimulation
- Record updated
- 11 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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 take part
- Contraindication for tDCS(i.e., cochlear implant)
- Pregnancy (checked with a pregnancy test)
- Refusal of the patients or their legal representatives
- Other persons protected under the CSP (judicial safeguard, family habilitation)
Where in France
- Hopital VinatierLyon, FranceContact: DEMILY MD CAROLINE, PHTaking people
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- Active tDCSExisting treatment, for comparison
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).
Treatment: Transcranial stimulation
- Sham tDCSPlacebo, for comparison
Group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current).
Treatment: Transcranial stimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 11 June 2026