tDCS for Catatonic Depression in Down Syndrome: A Pilot Study

NCT06866925 | Not Yet Recruiting

• 2 other identifiers: 2024-A00452-45PHRC-23-0027
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Down Syndrome

Keywords

catatonia

Outcome Measures

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.

  27 months

Secondary Outcomes (4)

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

  27 months

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

  27 months

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

  27 months

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

  27 months

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

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).

Device: Transcranial stimulation

Sham tDCS

PLACEBO COMPARATOR

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

Device: Transcranial stimulation

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.

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

MeSH Terms

Conditions

Down Syndrome; Catatonia

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• CAROLINE C DEMILY, MD PhD HDR

  HOPITAL VINATIER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JEROME J BRUNELIN, PhD, HDR)

CONTACT

00334 37 91 54 95; jerome.brunelin@ch-le-vinatier.fr

VERONIQUE V VIAL

CONTACT

0033437915522; veronique.vial@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter (6 sites), randomized, double-blind, parallel-group controlled study. Patients will be randomly assigned to a 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), or to a group receiving 15 sessions of sham stimulation (same electrode montage and stimulation duration, but without current). Participation in the EEG and biology component will be limited to the Lyon and Paris centers.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 10, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share