tDCS for Catatonic Depression in Down Syndrome: A Pilot Study
Recruiting · NCT06866925 · Interventional (participants receive a specific treatment) · Lead sponsor: Hôpital le Vinatier
View the official record on ClinicalTrials.gov →Interventions studied
Transcranial stimulation
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Hopital Vinatier - Lyon, Auvergne-Rhône-Alpes, France