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tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

RecruitingNAAges 18 Years - anyAllHôpital le Vinatier
NCT06866925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Transcranial stimulation
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Where

1 site
Hopital Vinatier
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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