Clinical trial NCT06139432: Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES)
Official title: Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Catatonia
Keywords: transcranial direct-current stimulation
brain stimulation
BFCRS
Chronic catatonia
tDCS
Neurostimulation
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Catatonia is a pathology combining affective, motor, behavioural and neuro-vegetative symptoms. Nearly 10% of people hospitalized in psychiatry have a catatonic syndrome. However, it is a severe disorder with a potentially lethal course.

For the treatment of catatonia, lorazepam is effective in most cases, with the percentage of responding patients varying between 70 and 80 per cent, according to the literature. Catatonic episodes resistant to lorazepam are usually associated with chronic catatonia as part of a neurodevelopmental disorder. Genetic abnormalities are often found in these forms of catatonia.

Electroconvulsive therapy (ECT) should be considered for any catatonic episode that is resistant to lorazepam. It is also indicated when a rapid effect must be obtained in life-threatening situations (e.g. malignant catatonia) or when the underlying pathology requires this treatment. Its efficacy is considered excellent, with response rates ranging from 59% to 100%, including when patients have not responded to lorazepam.

There are several limitations to ECT treatment for catatonia:

* There are many centres, particularly in France, where ECT is inaccessible. Delays in access to ECT are particularly acute in rural areas.
* ECT requires a pre-therapeutic assessment, delaying treatment by several days. However, catatonic syndrome is an emergency requiring immediate treatment. Delaying treatment exposes the patient to the risk of aggravation, i.e. malignant catatonia, with a life-threatening outcome.
* ECT treatment is sometimes contraindicated because of contraindications to anaesthesia.

Among neuromodulation techniques, the promising alternative approaches are transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS).

Transcranial direct current stimulation (tDCS) is a non-invasive electrical brain stimulation that does not require anaesthesia. The tDCS is based on applying a low direct electrical current (typically less than 20 volts) via two electrodes placed on the scalp. The electric current is applied to the anode (positive electrode) and then flows to the cathode (negative electrode). The electrodes, surrounded by sponges soaked in a saline solution, are positioned at the level of the scalp according to the international 10-20 placement system or, more rarely, according to the MRI-guided neuronavigation system. The device is easily transportable and does not require a specific technical platform.

The present study, randomized versus placebo, aims to test the efficacy of tDCS stimulation on catatonic-resistant syndrome.

Eligibility criteria: Inclusion Criteria:

* Men or women over 18 years old
* Under the care of the GHU PARIS Psychiatry and Neurosciences or EPS Ville Evrard.
* Suffering from an episode of catatonia according to the DSM-5 CRITERIA
* Persistence of catatonia criteria according to DSM-5 after 24 hours of lorazepam treatment or contraindication to lorazepam or poor tolerance to lorazepam
* Patient (or guardian) having given informed and written consent
* Beneficiary of a social security plan

Exclusion Criteria:

* Malignant catatonia
* Pregnant or breastfeeding women
* Patients with contraindications to tCDS, namely patients with a defibrillator or a pacemaker, brain stimulator, presence of intracranial metals, uncovered craniectomy or after trepanning.

Primary outcomes:
measure: Bush-Francis Catatonia Rating Scale (BFCRS)
timeFrame: Day 6
Secondary outcomes:
measure: Bush-Francis Catatonia Rating Scale (BFCRS)
timeFrame: Day 14
measure: Effectiveness of active tDCS vs sham: patients in remission after 20 sessions
timeFrame: every day from Day 1 to Day 14
measure: Lorazepam treatment (mg/die)
timeFrame: At baseline then every day from Day 1 to Day 14
measure: Percentage of patients requiring electroconvulsive therapy (ECT)
timeFrame: Every day from Day 1 to Day 14
measure: Occurrence of catatonic syndrome complications
timeFrame: Every day from Day 1 to Day 14
measure: To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: Montgomery-Asberg depression scale (MADRS score)
timeFrame: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
measure: To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: schizophrenia: . Positive and Negative Syndrome Scale (PANSS score)
timeFrame: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
measure: To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: hypomanic or manic episode: Young Mania Rating Scale (YMRS score)
timeFrame: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
measure: Evolution of physiological parameters: Electrocardiography (ECG)
timeFrame: Baseline then every day from Day 1 to Day 14
measure: Evolution of physiological parameters: blood pressure (systolic pressure and a diastolic pressure mm HG)
timeFrame: Baseline then every day from Day 1 to Day 14
measure: Evolution of physiological parameters: brething system
timeFrame: Baseline then every day from Day 1 to Day 14
measure: Evolution of physiological parameters: Body temperature °C
timeFrame: Baseline then every day from Day 1 to Day 14
measure: Evolution of physiological parameters: Skin conductance level (SCL)
timeFrame: Baseline then every day from Day 1 to Day 14
Other outcomes:
Locations:
city: Neuilly-sur-Marne
country: France
facility: CRC Pôle 93G03 Etablissement Public de Santé EPS Ville Evrard
state: Île-de-France
city: Paris
country: France
facility: Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
state: Île-de-France
Study officials:
affiliation: Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
name: Marion Plaze, MD,PHD
role: STUDY_CHAIR
affiliation: Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
name: Alexandre Haroche, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sienaert P, Dhossche DM, Vancampfort D, De Hert M, Gazdag G. A clinical review of the treatment of catatonia. Front Psychiatry. 2014 Dec 9;5:181. doi: 10.3389/fpsyt.2014.00181. eCollection 2014.
citation: Solmi M, Pigato GG, Roiter B, Guaglianone A, Martini L, Fornaro M, Monaco F, Carvalho AF, Stubbs B, Veronese N, Correll CU. Prevalence of Catatonia and Its Moderators in Clinical Samples: Results from a Meta-analysis and Meta-regression Analysis. Schizophr Bull. 2018 Aug 20;44(5):1133-1150. doi: 10.1093/schbul/sbx157.
citation: Sarkar S, Sakey S, Mathan K, Bharadwaj B, Kattimani S, Rajkumar RP. Assessing catatonia using four different instruments: Inter-rater reliability and prevalence in inpatient clinical population. Asian J Psychiatr. 2016 Oct;23:27-31. doi: 10.1016/j.ajp.2016.07.003. Epub 2016 Jul 11.
citation: Hawkins JM, Archer KJ, Strakowski SM, Keck PE. Somatic treatment of catatonia. Int J Psychiatry Med. 1995;25(4):345-69. doi: 10.2190/X0FF-VU7G-QQP7-L5V7.
citation: Haroche A, Giraud N, Vinckier F, Amad A, Rogers J, Moyal M, Canivet L, Berkovitch L, Gaillard R, Attali D, Plaze M. Efficacy of Transcranial Direct-Current Stimulation in Catatonia: A Review and Case Series. Front Psychiatry. 2022 Apr 27;13:876834. doi: 10.3389/fpsyt.2022.876834. eCollection 2022.
citation: Moyal M, Plaze M, Baruchet A, Attali D, Cravero C, Raffin M, Consoli A, Cohen D, Haroche A, Chaumette B. Efficacity of tDCS in catatonic patients with Phelan McDermid syndrome, a case series. Brain Stimul. 2022 Nov-Dec;15(6):1432-1434. doi: 10.1016/j.brs.2022.10.005. Epub 2022 Oct 26. No abstract available.