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Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES)

NCT06139432 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-24

No results posted yet for this study

Summary

Nearly 10% of people hospitalized in psychiatry have a catatonic syndrome. The treatment of this syndrome is based on lorazepam and electro-convulsive therapy (ECT) in drug-resistant forms. ECT is the reference therapy, very effective in catatonia, but remain difficult to access due to the technical platform required for their realization, leading to delays in the implementation of the treatment responsible for an increase in the morbidity and mortality of catatonia. In this context, a new therapeutic tool available in the treatment of drug-resistant catatonia would improve the prognosis of catatonia. Transcranial direct current stimulation (tDCS) is an alternative, non-invasive brain stimulation technique that does not require anesthesia, and inexpensive and has been shown to be effective in depression and schizophrenia. A series of clinical cases suggests its potential efficacy in catatonia. Our objective is to evaluate the efficacy of tDCS in catatonia in a clinical trial.

Conditions

  • Catatonia

Interventions

DEVICE

Active tDCS

* Anode opposite the left dorsolateral prefrontal cortex (between F3 and FP1 according to the 10-20 international placement system). * Cathode opposite the left temporoparietal junction (between T3 and P3). * The stimulation level is 2mA for 20 minutes. * Sessions are held twice daily on working days (with a minimum of 3 hours between sessions). Twenty sessions will be carried out, two sessions per consecutive working day.

DEVICE

Sham tDCS

* Anode opposite the left dorsolateral prefrontal cortex (between F3 and FP1 according to the 10-20 international placement system). * Cathode opposite the left temporoparietal junction (between T3 and P3). * Effective stimulation is delivered for 30 seconds (stimulation level is 2 mA), after which effective stimulation stops. The entire session is 20 minutes, with 19 minutes and 30 seconds without stimulation. * Sessions are held twice daily on working days (with a minimum of 3 hours between sessions). Twenty sessions will be carried out, two sessions per consecutive working day.

Sponsors & Collaborators

  • Centre Hospitalier St Anne

    lead OTHER

Principal Investigators

  • Marion Plaze, MD,PHD · Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences

  • Alexandre Haroche, MD,PHD · Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139432 on ClinicalTrials.gov