CATATOnia treatment with transcranial direct current electrostimulation: protocol of a randomised, double-blind, placebo-controlled bicentric superiority study (CATATOES)
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.008 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.009 | 0.002 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.029 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".