NCT06866925 tDCS for Catatonic Depression in Down Syndrome: A Pilot Study
| NCT ID | NCT06866925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital le Vinatier |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-09-12 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
CAROLINE C DEMILY, MD PhD HDR
PRINCIPAL INVESTIGATOR
HOPITAL VINATIER
Frequently Asked Questions
Who can join the NCT06866925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06866925 currently recruiting?
Yes, NCT06866925 is actively recruiting participants. Contact the research team at jerome.brunelin@ch-le-vinatier.fr for enrollment information.
Where is the NCT06866925 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06866925 clinical trial?
NCT06866925 is sponsored by Hôpital le Vinatier. The principal investigator is CAROLINE C DEMILY, MD PhD HDR at HOPITAL VINATIER. The trial plans to enroll 62 participants.