tDCS for Catatonic Depression in Down Syndrome: A Pilot Study
ConditionDown Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier
About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Transcranial stimulation
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov