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. 2025 Oct 8;25(1):949.
doi: 10.1186/s12888-025-07266-5.

CATATOnia treatment with transcranial direct current electrostimulation: protocol of a randomised, double-blind, placebo-controlled bicentric superiority study (CATATOES)

Mylène Moyal  1   2 , David Attali  3   4 , Alice Le Berre  3   5 , Noomane Bouaziz  6 , Anton Iftimovici  3   5 , François Ramon  5 , Adèle Henensal  3   5 , Louise Dahan  5 , Laetitia Canivet  3 , Ghita Dadi  3 , Clément Debacker  3   5 , Maliesse Lui  3 , Sylvain Charron  5 , Anaëlle Alouit  5   7 , Khaoussou Sylla  3 , Rossella Letizia Mancusi  3 , Thierry Gallarda  3 , Arnaud Cachia  5   8 , Martine Gavaret  3   5 , Boris Chaumette  3   5   9 , Catherine Oppenheim  3   5 , Dominique Januel  6   10 , Marion Plaze #  3   5 , Alexandre Haroche #  3   5
Affiliations

CATATOnia treatment with transcranial direct current electrostimulation: protocol of a randomised, double-blind, placebo-controlled bicentric superiority study (CATATOES)

Mylène Moyal et al. BMC Psychiatry. .

Abstract

Background: Catatonia is a severe psychomotor syndrome with high morbidity and mortality. Lorazepam and electroconvulsive therapy (ECT) are the main recommended treatments. Lorazepam-resistant catatonia accounts for about 30% of cases, particularly in neurodevelopmental disorders. ECT is crucial in these situations but faces challenges of tolerability and accessibility. Transcranial direct current stimulation (tDCS), a promising intervention, is emerging as a non-invasive, cost-effective neurostimulation tool and has demonstrated efficacy and safety in case reports and small series of catatonic patients (N < 10). The CATATOES study aims to assess the efficacy and safety of tDCS using a randomised, double-blind, placebo-controlled, bicentric superiority trial involving 70 patients with catatonia. Secondary objectives aim to highlight the mechanism of action of tDCS and to explore the pathophysiology of catatonia.

Methods: Seventy participants with lorazepam-resistant catatonia will undergo 20 sessions of active or sham tDCS, administered twice daily at two mA for 20 min, with anodal stimulation in the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation in the left temporoparietal junction (TPJ). In addition to daily clinical assessment, patients will undergo (i) structural, functional and diffusion magnetic resonance imaging (MRI), (ii) 64-channel resting state electroencephalogram (EEG), and (iii) blood test with inflammatory, neurogenesis and genetic markers, before, during and after the treatment course.

Discussion: Catatonia is in critical need of therapeutic improvement. We anticipate that this study will pave the way for the routine use of tDCS in the treatment of lorazepam-resistant catatonia, ultimately contributing to a reduction of morbidity, mortality, and associated costs of catatonia. ClinicalTrials.gov Identifier NCT06139432; Registration date 11/24/2023.

Supplementary Information: The online version contains supplementary material available at 10.1186/s12888-025-07266-5.

Keywords: Catatonic syndrome; EEG; Genetic; MRI; Neuroinflammation; Neuromodulation; TDCS.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was authorised by the ethics committee CPP (Comité de protection des personnes) Ouest V, approval number 2022-A00204-39, in accordance with the Declaration of Helsinki, and is registered on ClinicalTrials.gov under NCT06139432. Written informed consent will be obtained from the patient, their guardian, or trusted person if the patient cannot provide consent due to catatonia. After the screening, a reflection delay of at least 24 h will be respected before the inclusion visit (V0), see Fig. 2. To navigate potential challenges related to obtaining patient consent due to catatonic symptoms, the ethical committee has agreed to implement an emergency clause and provide the option for temporary consent by the patient’s relative. This study was approved by the ethics committee “Comité de protection des personnes” Ouest V (Approval Number: 2022-A00204-39), and is registered on ClinicalTrials.gov under NCT06139432. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Estimation of the electric field distribution induced by transcranial direct current stimulation (tDCS) using a frontotemporal electrode montage. The configuration employed two electrodes measuring 7 × 5 cm with a current intensity of 2 mA. The anodal electrode was positioned over the left prefrontal dorsolateral cortex, corresponding to the midpoint between positions Fp1 and F3, while the cathodal electrode was placed over the left temporoparietal junction, midway between T3 and P3. The resulting electric field strength was scaled from 0 V/m (blue, minimum) to 0.4 V/m (red, maximum). Simulations were conducted using the ROAST toolbox (Realistic vOlumetric Approach to Simulate Transcranial Electric Stimulation), utilizing subject-specific structural MRI data
Fig. 2
Fig. 2
Protocol design. V for Visit
See this image and copyright information in PMC

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