Clinical Trial

tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

Study acronym: TOTORO
Recruiting
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-04; most recent amendment 2026-06-10.
Status change: Not Yet Recruiting → Recruiting 2026-06-10
Trial Details
NCT Number NCT06866925
Lead Sponsor Hôpital le Vinatier
Conditions Down Syndrome
Enrollment 62 participants
Start Date 2025-09-12
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-11