Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES)
NCT ID: NCT06139432
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2023-12-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active transcranial Direct Current Stimulation
Active transcranial Direct Current Stimulation (tDCS): Stimulation of 2mA for 20 minutes
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.
Sham transcranial Direct Current Stimulation
Sham transcranial Direct Current Stimulation (tDCS): Effective stimulation of 2.5 mA for 30 seconds, then the stimulation stops. The complete session lasts 20 minutes, with 19 minutes and 30 seconds without stimulation.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Marion Plaze, MD,PHD
Role: STUDY_CHAIR
Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
Alexandre Haroche, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
Locations
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CRC Pôle 93G03 Etablissement Public de Santé EPS Ville Evrard
Neuilly-sur-Marne, Île-de-France Region, France
Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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D21-P022
Identifier Type: -
Identifier Source: org_study_id