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Transcranial Direct Current Stimulation as a Treatment for Depression With Catatonic Features in Patients With Down Syndrome: a Pilot Randomized Sham-controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hopital Vinatier
RECRUITING
Lyon
Contact Information
Primary
JEROME J BRUNELIN, PhD, HDR)
jerome.brunelin@ch-le-vinatier.fr
00334 37 91 54 95
Backup
VERONIQUE V VIAL
veronique.vial@ch-le-vinatier.fr
0033437915522
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 62
Treatments
Active_comparator: Active tDCS
Group receiving 15 sessions of active tDCS (3 sessions per day for 5 days, from D0 to D5, with the tDCS anode placed over the left DLPFC and the cathode over the right DLPFC, located using the international 10/20 electrode placement system, each stimulation lasting 20 minutes at 2mA).
Placebo_comparator: Sham tDCS
Group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current).
Related Therapeutic Areas
Sponsors
Leads: Hôpital le Vinatier

This content was sourced from clinicaltrials.gov