tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

Sponsor
Hôpital le Vinatier
Study ID
NCT06866925
Status
Recruiting
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Conditions

  • Down Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial stimulation — DEVICE
    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.

Study Details

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 Dates

First listed
Mar 10, 2025
Start date
Sep 12, 2025
Status verified
Jun 2026
Primary completion
Aug 1, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS) [ Time Frame: 27 months ]

Central Contacts

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