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CatatoniaCATATOESNCT06139432

Catatonia: Effectiveness of Transcranial Direct Current Electrostimulation (CATATOES)

A study testing Active tDCS in people with Catatonia, run by Centre Hospitalier St Anne at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Catatonia
What is being tested?
Active tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesFrance
Study dates
1 Dec 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Alexandre Haroche, MD, PHD contact

(0)145658714

a.haroche@ghu-paris.fr

Marion Plaze, MD,PHD contact

(0)145657665 ext. +33

m.plaze@ghu-paris.fr

France2 sites

  • CRC Pôle 93G03 Etablissement Public de Santé EPS Ville Evrard

    Neuilly-sur-Marne, Île-de-France Region, 93330

    Noomane Bouaziz, MD,PHD, (0)143093232, n.bouaziz@epsve.fr

    Dominique Januel, MD,PHD, (0)149717159, d.januel@epsve.fr

  • Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences

    Paris, Île-de-France Region, 75014

    Alexandre Haroche, MD,PHD, 0145658714, a.haroche@ghu-paris.fr

    Marion Plaze, MD,PHD, 0145657665, m.plaze@ghu-paris.fr

Other trials in France

About this study

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.

Read the 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.

Conditions
Catatonia
Being tested
Active tDCS, Sham tDCS
Keywords
transcranial direct-current stimulation, brain stimulation, BFCRS, Chronic catatonia, tDCS, Neurostimulation
Medical subject headings
Catatonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active tDCSDevice

    Also called Active transcranial Direct Current Stimulation

    • 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 tDCSDevice

    Also called Sham transcranial Direct Current Stimulation

    • 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.

Study groups in NCT06139432
Study groupRoleWhat they receive
Active transcranial Direct Current StimulationExperimentalActive transcranial Direct Current Stimulation (tDCS): Stimulation of 2mA for 20 minutes
Receives: Device: Active tDCS
Sham transcranial Direct Current StimulationSham comparatorSham 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.
Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bush-Francis Catatonia Rating Scale (BFCRS)

    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)

    Measured: Day 6

Secondary outcomes (13)

  1. Bush-Francis Catatonia Rating Scale (BFCRS)

    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.

    Measured: Day 14

  2. Effectiveness of active tDCS vs sham: patients in remission after 20 sessions

    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.

    Measured: every day from Day 1 to Day 14

  3. Lorazepam treatment (mg/die)

    Lorazepam daily administration in mg/die

    Measured: At baseline then every day from Day 1 to Day 14

  4. Percentage of patients requiring electroconvulsive therapy (ECT)

    Percentage of patients requiring electroconvulsive therapy (ECT) during the evaluation period (active vs shamm tDCS)

    Measured: Every day from Day 1 to Day 14

  5. Occurrence of catatonic syndrome complications

    Pulmonary embolism confirmed by angioscan, transfer to intensive care, pressure sores, inhalation pneumonia requiring antibiotic therapy, death.

    Measured: Every day from Day 1 to Day 14

  6. To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: Montgomery-Asberg depression scale (MADRS score)

    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).

    Measured: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14

  7. To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: schizophrenia: . Positive and Negative Syndrome Scale (PANSS score)

    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.

    Measured: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14

  8. To assess the effectiveness of tDCS by comparing changes over time in psychiatric symptomatology: hypomanic or manic episode: Young Mania Rating Scale (YMRS score)

    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)

    Measured: At baseline, then at Day 1, Day 6, and from Day 11 to Day 14

  9. Evolution of physiological parameters: Electrocardiography (ECG)

    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 )

    Measured: Baseline then every day from Day 1 to Day 14

  10. Evolution of physiological parameters: blood pressure (systolic pressure and a diastolic pressure mm HG)

    Blood pressure (systolic pressure and a diastolic pressure mm HG)

    Measured: Baseline then every day from Day 1 to Day 14

  11. Evolution of physiological parameters: brething system

    Brething system: breaththig freaquency ( breath per minute);

    Measured: Baseline then every day from Day 1 to Day 14

  12. Evolution of physiological parameters: Body temperature °C

    Body temperature °C

    Measured: Baseline then every day from Day 1 to Day 14

  13. Evolution of physiological parameters: Skin conductance level (SCL)

    Skin conductance level (SCL value μS)

    Measured: Baseline then every day from Day 1 to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139432
Sponsor's protocol ID
D21-P022
Acronym
CATATOES
Status last verified
Nov 2023
First submitted
3 Nov 2023
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25538636

  • 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.

    PubMed 29140521

  • 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.

    PubMed 27969074

  • 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.

    PubMed 8822386

  • 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.

    PubMed 35573356

  • 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.

    PubMed 36309344

  • Moyal M, Attali D, Berre AL, Bouaziz N, Iftimovici A, Ramon F, Henensal A, Dahan L, Canivet L, Dadi G, Debacker C, Lui M, Charron S, Alouit A, Sylla K, Mancusi RL, Gallarda T, Cachia A, Gavaret M, Chaumette B, Oppenheim C, Januel D, Plaze M, Haroche A. CATATOnia treatment with transcranial direct current electrostimulation: protocol of a randomised, double-blind, placebo-controlled bicentric superiority study (CATATOES). BMC Psychiatry. 2025 Oct 8;25(1):949. doi: 10.1186/s12888-025-07266-5.

    PubMed 41062970

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS in people with Catatonia, run by Centre Hospitalier St Anne at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexandre Haroche, MD, PHD ((0)145658714, a.haroche@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bush-Francis Catatonia Rating Scale (BFCRS) (time frame: Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06139432, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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