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tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

Key facts

Who runs it
Hôpital le Vinatier
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
62 people, planned
Started
12 Sept 2025
Expected to end
30 Sept 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Transcranial stimulation
Record updated
11 June 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Contraindication for tDCS(i.e., cochlear implant)
  • Pregnancy (checked with a pregnancy test)
  • Refusal of the patients or their legal representatives
  • Other persons protected under the CSP (judicial safeguard, family habilitation)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Active tDCSExisting treatment, for comparison

    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).

    Treatment: Transcranial stimulation

  • Sham tDCSPlacebo, for comparison

    Group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current).

    Treatment: Transcranial stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Transcranial Direct Current Stimulation as a Treatment for Depression With Catatonic Features in Patients With Down Syndrome: a Pilot Randomized Sham-controlled Study
Record updated
11 June 2026