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Clinical Trials in France / NCT06866925
Recruiting Not applicable

tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

NCT06866925 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital le Vinatier
Phase
Not applicable
Started
2025-09-12
Last updated
2026-06-11

Condition(s) studied

Down Syndrome

Investigational drug(s) / intervention(s)

Transcranial stimulation

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS) — 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.

Trial sites (1)

FacilityCityRegionStatus
Hopital Vinatier Lyon Auvergne-Rhône-Alpes Recruiting

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Other trials for the same condition

Down Syndrome, Physical Activity and Sleep Apnea Recruiting
Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin Recruiting
Trial-Ready Cohort-Down Syndrome (TRC-DS) Recruiting
Genetic and Epigenetic Variations in Heterokaryotypic Monozygotic Twins Discordant for Down Syndrome Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06866925 on ClinicalTrials.gov ↗ ← All trials in France