NCT06139432

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

November 3, 2023

Last Update Submit

November 22, 2023

Conditions

Catatonia

Keywords

transcranial direct-current stimulationbrain stimulationBFCRSChronic catatoniatDCSNeurostimulation

Outcome Measures

Primary Outcomes (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)

    Day 6

Secondary Outcomes (13)

  • Bush-Francis Catatonia Rating Scale (BFCRS)

    Day 14

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

    every day from Day 1 to Day 14

  • Lorazepam treatment (mg/die)

    At baseline then every day from Day 1 to Day 14

  • Percentage of patients requiring electroconvulsive therapy (ECT)

    Every day from Day 1 to Day 14

  • Occurrence of catatonic syndrome complications

    Every day from Day 1 to Day 14

  • +8 more secondary outcomes

Study Arms (2)

Active transcranial Direct Current Stimulation

EXPERIMENTAL

Active transcranial Direct Current Stimulation (tDCS): Stimulation of 2mA for 20 minutes

Device: Active tDCS

Sham transcranial Direct Current Stimulation

SHAM COMPARATOR

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.

Device: Sham tDCS

Interventions

Active tDCSDEVICE

* 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.

Also known as: Active transcranial Direct Current Stimulation
Active transcranial Direct Current Stimulation
Sham tDCSDEVICE

* 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.

Also known as: Sham transcranial Direct Current Stimulation
Sham transcranial Direct Current Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CRC Pôle 93G03 Etablissement Public de Santé EPS Ville Evrard

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

Location

Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences

Paris, Île-de-France Region, 75014, France

Location

Related Publications (6)

  • 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.

    PMID: 25538636BACKGROUND

  • 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.

    PMID: 29140521BACKGROUND

  • 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.

    PMID: 27969074BACKGROUND

  • 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.

    PMID: 8822386BACKGROUND

  • 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.

    PMID: 35573356BACKGROUND

  • 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.

    PMID: 36309344BACKGROUND

MeSH Terms

Conditions

Catatonia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Marion Plaze, MD,PHD

    Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences

    STUDY CHAIR

  • Alexandre Haroche, MD,PHD

    Groupe Hospitalier Universitaire (GHU) Psychiatrie et Neurosciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Haroche, MD, PHD

CONTACT

(0)145658714a.haroche@ghu-paris.fr

Marion Plaze, MD,PHD

CONTACT

(0)145657665m.plaze@ghu-paris.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 18, 2023

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)