- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06139432
Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES) (CATATOES)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandre Haroche, MD, PHD
- Phone Number: (0)145658714
- Email: a.haroche@ghu-paris.fr
Study Contact Backup
- Name: Marion Plaze, MD,PHD
- Phone Number: +33 (0)145657665
- Email: m.plaze@ghu-paris.fr
Study Locations
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Île-de-France
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Neuilly-sur-Marne, Île-de-France, France, 93330
- CRC Pôle 93G03 Etablissement Public de Santé EPS Ville Evrard
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Contact:
- Noomane Buaziz, MD,PHD
- Phone Number: (0)143093232
- Email: n.buaziz@epsve.fr
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Contact:
- Dominique Januel, MD,PHD
- Phone Number: (0)149717159
- Email: d.januel@epsve.fr
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Paris, Île-de-France, France, 75014
- Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
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Contact:
- Alexandre Haroche, MD,PHD
- Phone Number: 0145658714
- Email: a.haroche@ghu-paris.fr
-
Contact:
- Marion Plaze, MD,PHD
- Phone Number: 0145657665
- Email: m.plaze@ghu-paris.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active transcranial Direct Current Stimulation
Active transcranial Direct Current Stimulation (tDCS): Stimulation of 2mA for 20 minutes
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Twenty sessions will be carried out, two sessions per consecutive working day.
Other Names:
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Sham Comparator: 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.
|
Twenty sessions will be carried out, two sessions per consecutive working day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bush-Francis Catatonia Rating Scale (BFCRS)
Time Frame: Day 6
|
The BFCRS is a comprehensive tool for diagnosing and assessing the severity of catatonic syndrome. The BFCRS was devised by Bush, Fink, Petrides, Dowling and Francis in 1996. This scale consists of the assessment of 23 symptoms, scored from 0 to 3. The total score of the BFCRS is the sum of the responses to the 23 items (minimum 0 - maximum 69). High scores reflect a severe disorder. Improvement is defined by a 30% decrease in BFCRS scores after 5 days of treatment (10 tDCS sessions) |
Day 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bush-Francis Catatonia Rating Scale (BFCRS)
Time Frame: Day 14
|
The BFCRS is a comprehensive tool for diagnosing and assessing the severity of catatonic syndrome. The BFCRS was devised by Bush, Fink, Petrides, Dowling and Francis in 1996. This scale consists of the assessment of 23 symptoms, scored from 0 to 3. The total score of the BFCRS is the sum of the responses to the 23 items (minimum 0 - maximum 69). High scores reflect a severe disorder. The treatment response is assessed as the absolute reduction of the BCRF score after 20 sessions. |
Day 14
|
Effectiveness of active tDCS vs sham: patients in remission after 20 sessions
Time Frame: every day from Day 1 to Day 14
|
Percentage of patients who no longer fulfil the DSM-5 criteria for catatonic syndrome.
This criterion was assessed at each session between V1 and V14.
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every day from Day 1 to Day 14
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Lorazepam treatment (mg/die)
Time Frame: At baseline then every day from Day 1 to Day 14
|
Lorazepam daily administration in mg/die
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At baseline then every day from Day 1 to Day 14
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Percentage of patients requiring electroconvulsive therapy (ECT)
Time Frame: Every day from Day 1 to Day 14
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Percentage of patients requiring electroconvulsive therapy (ECT) during the evaluation period (active vs shamm tDCS)
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Every day from Day 1 to Day 14
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Occurrence of catatonic syndrome complications
Time Frame: Every day from Day 1 to Day 14
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Pulmonary embolism confirmed by angioscan, transfer to intensive care, pressure sores, inhalation pneumonia requiring antibiotic therapy, death.
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Every day from Day 1 to Day 14
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To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: Montgomery-Asberg depression scale (MADRS score)
Time Frame: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
|
The Montgomery-Asberg depression scale (MADRS ) is a 10 -item scale used to assess the severity of depression.
High scores reflect a severe disorder (score range 0-60).
|
At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
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To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: schizophrenia: . Positive and Negative Syndrome Scale (PANSS score)
Time Frame: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
|
PANSS (Positive and Negative Syndrome Scale): is a 30-item scale widely used in schizophrenia research to assess positive and negative psychotic dimensions.
The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale.
Each subscale is rated with 1 to 7 points ranging from absent to extreme.
The range for the Positive and Negative Scales is 7-49, and the range for the General Psychopathology Scale is 16-112.
The total PANSS score is simply the sum of the sub scales.
In addition to these measures, a Composite Scale is scored by subtracting the negative score from the positive score.
This yields a bipolar index that ranges from -42 to +42, which is essentially a difference score reflecting the degree of predominance of one syndrome in relation to the other.
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At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
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To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: hypomanic or manic episode: Young Mania Rating Scale (YMRS score)
Time Frame: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
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The Young Mania Rating Scale (YMRS) is a rating scale used to evaluate manic symptoms : there are eleven items, each item given a severity rating.
Four are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.High scores reflect a severe disorder (score range 0-60)
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At baseline, then at Day 1, Day 6, and from Day 11 to Day 14
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Evolution of physiological parameters: Electrocardiography (ECG)
Time Frame: Baseline then every day from Day 1 to Day 14
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ECG values for waves and intervals: RR interval(seconds);P wave (milliseconds); PR (milliseconds);PR segment (milliseconds); QRS complex (milliseconds) ;ST segment (milliseconds); T wave:(milliseconds) ;QT interval (milliseconds )
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Baseline then every day from Day 1 to Day 14
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Evolution of physiological parameters: blood pressure (systolic pressure and a diastolic pressure mm HG)
Time Frame: Baseline then every day from Day 1 to Day 14
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Blood pressure (systolic pressure and a diastolic pressure mm HG)
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Baseline then every day from Day 1 to Day 14
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Evolution of physiological parameters: brething system
Time Frame: Baseline then every day from Day 1 to Day 14
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Brething system: breaththig freaquency ( breath per minute);
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Baseline then every day from Day 1 to Day 14
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Evolution of physiological parameters: Body temperature °C
Time Frame: Baseline then every day from Day 1 to Day 14
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Body temperature °C
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Baseline then every day from Day 1 to Day 14
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Evolution of physiological parameters: Skin conductance level (SCL)
Time Frame: Baseline then every day from Day 1 to Day 14
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Skin conductance level (SCL value μS)
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Baseline then every day from Day 1 to Day 14
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marion Plaze, MD,PHD, Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
- Principal Investigator: Alexandre Haroche, MD,PHD, Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D21-P022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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