Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia

NCT06176456 | Unknown

• 1 other identifier: RECATA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation effectiveness and safety of TMS in subjects with catatonia

Conditions

Catatonia; Schizophrenia; Schizo Affective Disorder; Bipolar Affective Disorder

Outcome Measures

Primary Outcomes (3)

• The rate of onset of the primary response

  Reduction of points on the BPRS and NCRS scales to 70% of the initial

  6 months

• The number of patients with a positive effect of therapy

  Reduction of the total score on BFCRS and NCRS by at least 50%

  6 months

• The number of patient with the improvement

  The total score for BFCRS and NCRS is no more than 3 points

  6 months

Study Arms (3)

10 sessions with a frequency of 1 Hz

ACTIVE COMPARATOR

10 sessions with a frequency of 1 Hz with an amplitude of 120% of the evoked motor response in the projection of the left Dorsolateral prefrontal cortex 1600 pulses per session with total duration of procedure \~ 20 minutes

Diagnostic Test: rTMS

10 sessions with a frequency of 20 Hz

ACTIVE COMPARATOR

10 sessions with a frequency of 20 Hz with an amplitude of 120% of the evoked motor response in the projection of Dorsolateral prefrontal cortex (1600 pulses per session with total duration of the procedure \~ 20 minutes)

Diagnostic Test: rTMS

10 placebo sessions

PLACEBO COMPARATOR

The coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses.

Other: Placebo

Interventions

rTMS DIAGNOSTIC_TEST

Active regiment

10 sessions with a frequency of 1 Hz; 10 sessions with a frequency of 20 Hz

Placebo OTHER

Tactile artefacts without magnetic pulses

10 placebo sessions

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Verified diagnosis of schizophrenic or affective spectrum (schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)
• Patient's ability (possibly accompanied by caregivers) to undergo diagnostic and therapeutic procedures;
• The presence of residual catatonia in the form of such psychomotor anomalies as:
• disorganisation of thinking with speech disturbance with verbigerations and/or sperrungs
• hypo- and hyperkinetic psychomotor phenomena;
• substupor without disturbance of consciousness;
• elective mutism;
• echo phenomena (echolalia and/or echopraxia);
• phenomena of "wax flexibility"
• speech and behavioral stereotypy
• pathetic exaltation phenomena
• the phenomenon of irritative asthenia
• dysuric phenomena (monotonous activity and rigidity of affect)

You may not qualify if:

• patient's refusal to participate in the study
• acute hallucinatory-delusional symptoms
• suicide risk
• a patient taking prohibited therapy products
• neuroleptic complications of antipsychotic therapy
• irritative asthenia
• dysuric phenomena by the type of monotonous activity and rigidity of affect

Sponsors & Collaborators

• Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev: lead

Study Sites (1)

"Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia

Moscow, Russia

RECRUITING

Related Publications (23)

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• 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.

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• Aandi Subramaniyam B, Muliyala KP, Suchandra HH, Reddi VSK. Diagnosing catatonia and its dimensions: Cluster analysis and factor solution using the Bush Francis Catatonia Rating Scale (BFCRS). Asian J Psychiatr. 2020 Aug;52:102002. doi: 10.1016/j.ajp.2020.102002. Epub 2020 Apr 10.

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• Structure and Functions of the Human Prefrontal Cortex. Proceedings of a conference. New York City, New York, USA. March 2-4, 1995. Ann N Y Acad Sci. 1995 Dec 15;769:1-411. No abstract available.

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• Stip E, Blain-Juste ME, Farmer O, Fournier-Gosselin MP, Lesperance P. Catatonia with schizophrenia: From ECT to rTMS. Encephale. 2018 Apr;44(2):183-187. doi: 10.1016/j.encep.2017.09.008. Epub 2017 Dec 11.

  PMID: 29241672 BACKGROUND

• Hansbauer M, Wagner E, Strube W, Roh A, Padberg F, Keeser D, Falkai P, Hasan A. rTMS and tDCS for the treatment of catatonia: A systematic review. Schizophr Res. 2020 Aug;222:73-78. doi: 10.1016/j.schres.2020.05.028. Epub 2020 Jun 26.

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• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

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• Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

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MeSH Terms

Conditions

Catatonia; Schizophrenia; Psychotic Disorders; Bipolar Disorder

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Central Study Contacts

Natalia Zakharova, MD, PhD

CONTACT

+7 906 052 02 57; nataliza80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The design of the study involves following stages: * diagnostic stage and randomization; * 10 sessions of placebo-controlled stimulation protocols (high- and low-frequency magnetic pulses) * primary analysis of the effectiveness of protocols after 10 sessions of stimulation, followed by the transfer of all patients, including the placebo group to the most effective stimulation regiment (20 sessions of active neuromodulation) * final analysis of the effectiveness after 20 sessions of TMS and follow-up period (visits after 1 month and 6 months)

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: December 19, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

RU (1)