tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Down Syndrome

In brief

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

Key facts

Study ID

NCT06866925

Run by

Hôpital le Vinatier

People needed

62

Starts

2025-09-12

Expected to finish

2027-09-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Hopital Vinatier — Lyon, Auvergne-Rhône-Alpes, France (enrolling)

Full record on ClinicalTrials.gov

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