tDCS for Catatonic Depression in Down Syndrome: A Pilot Study
Transcranial Direct Current Stimulation as a Treatment for Depression With Catatonic Features in Patients With Down Syndrome: a Pilot Randomized Sham-controlled Study
Hôpital le Vinatier
62 participants
Sep 12, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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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Interventions
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.
Locations(1)
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NCT06866925