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tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

ConditionDown Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Active tDCSActive comparator 1 intervention
Group B: Sham tDCSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acute changes on depressive / catatonic symptoms between D0 and D5 measured with the Bush-Francis Catatonia Rating Scale (BFCRS)

The primary outcome will be the acute changes in the severity of catatonic symptoms measured by the BFCRS evaluated before treatment (D0) and after the tDCS regimen (D5). The analyses will be performed on a strict intention-to-treat sample of the evaluable patients defined in the protocol as patients with a baseline assessment and at least one post-tDCS score.

Time frame
27 months

Secondary outcomes

1

Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects

Bush-Francis Catatonia Rating Scale (BFCRS)

Time frame
27 months
2

Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects

Montgomery-Åsberg Depression Rating Scale (MADRS)

Time frame
27 months
3

Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects

Unified Parkinson's Disease Rating Scale (UPDRS)

Time frame
27 months
4

Changes in clinical and cognitive will be also assessed at M1 and M3, allowing the evaluation of tDCS-induced long-term effects

Severe Impairment Battery scale (SIB)

Time frame
27 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hôpital le Vinatier

Lead sponsor

Source ClinicalTrials.gov
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