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

Schizophrenia Clinical Trial

— RECATA  

Official title:

Interventional Triple-negative Placebo-controlled Personalized Prospective Study "Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176456
• Other study ID #: RECATA
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev
• Contact: Natalia Zakharova, MD, PhD
• Phone: +7 906 052 02 57
• Email: nataliza80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation effectiveness and safety of TMS in subjects with catatonia

Description:

Non-pharmacological strategies for influencing brain structures show great potential, particularly transcranial magnetic stimulation (TMS), which allows targeting specific areas of the brain and activating neuroplastic processes that contribute to the restoration of lost functions. According to study hypothesis, therapy for catatonia is possible through the stimulation of the dorsolateral prefrontal cortex (DLPFC), given its accessibility and role in the syndrome's development because. It has been established that a key process in the pathogenesis of catatonia is the disruption of the structural-functional connectivity and activity of several regions within the fronto-temporal network

The design of the study involves following stages:

• diagnostic stage and randomization

• two personalized stimulation protocols (high- and low-frequency delivery of magnetic pulses) with placebo control

• initial 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 protocol.

• the stage of active neuromodulation of 20 sessions (4 weeks) according to the protocol of effective stimulation regiment

• final analysis of the effectiveness after 20 sessions of TMS, as well as after 1 and 6 months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Catatonia
• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

Diagnostic Test:
• rTMS
Active regiment

Other:
• Placebo
Tactile artefacts without magnetic pulses

Locations

Country	Name	City	State
Russian Federation	"Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev

Country where clinical trial is conducted

Russian Federation, 

References & Publications (23)

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. — View Citation

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. Erratum In: Lancet. 2018 Jun 23;391(10139):e24. — View Citation

Di Michele V, Bolino F. A novel treatment option of bipolar depression with psychotic and catatonic features. Gen Hosp Psychiatry. 2006 Jul-Aug;28(4):364-5. doi: 10.1016/j.genhosppsych.2006.05.003. No abstract available. — View Citation

Fink M, Taylor MA. Catatonia: subtype or syndrome in DSM? Am J Psychiatry. 2006 Nov;163(11):1875-6. doi: 10.1176/ajp.2006.163.11.1875. No abstract available. — View Citation

Gansler DA, McLaughlin NC, Iguchi L, Jerram M, Moore DW, Bhadelia R, Fulwiler C. A multivariate approach to aggression and the orbital frontal cortex in psychiatric patients. Psychiatry Res. 2009 Mar 31;171(3):145-54. doi: 10.1016/j.pscychresns.2008.03.007. Epub 2009 Feb 11. — View Citation

Grisaru N, Chudakov B, Yaroslavsky Y, Belmaker RH. Catatonia treated with transcranial magnetic stimulation. Am J Psychiatry. 1998 Nov;155(11):1630. No abstract available. — View Citation

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. — View Citation

Hirjak D, Rashidi M, Kubera KM, Northoff G, Fritze S, Schmitgen MM, Sambataro F, Calhoun VD, Wolf RC. Multimodal Magnetic Resonance Imaging Data Fusion Reveals Distinct Patterns of Abnormal Brain Structure and Function in Catatonia. Schizophr Bull. 2020 Jan 4;46(1):202-210. doi: 10.1093/schbul/sbz042. — View Citation

Il'ina NA, Zakharova NV. [Long-term dyskinetic remissions in shift-like schizophrenia]. Zh Nevrol Psikhiatr Im S S Korsakova. 2010;110(12):17-23. Russian. — View Citation

Kate MP, Raju D, Vishwanathan V, Khan FR, Nair, Thomas SV. Successful treatment of refractory organic catatonic disorder with repetitive transcranial magnetic stimulation (rTMS) therapy. J Neuropsychiatry Clin Neurosci. 2011 Summer;23(3):E2-3. doi: 10.1176/jnp.23.3.jnpe2. No abstract available. — View Citation

Northoff G, Kotter R, Baumgart F, Danos P, Boeker H, Kaulisch T, Schlagenhauf F, Walter H, Heinzel A, Witzel T, Bogerts B. Orbitofrontal cortical dysfunction in akinetic catatonia: a functional magnetic resonance imaging study during negative emotional stimulation. Schizophr Bull. 2004;30(2):405-27. doi: 10.1093/oxfordjournals.schbul.a007088. — View Citation

Oulis P, Lykouras L. Prevalence and diagnostic correlates of DSM-IV catatonic features among psychiatric inpatients. J Nerv Ment Dis. 1996 Jun;184(6):378-9. doi: 10.1097/00005053-199606000-00010. No abstract available. — View Citation

Pommepuy N, Januel D. [Catatonia: resurgence of a concept. A review of the international literature]. Encephale. 2002 Nov-Dec;28(6 Pt 1):481-92. French. — View Citation

Rolls ET. The orbitofrontal cortex. Philos Trans R Soc Lond B Biol Sci. 1996 Oct 29;351(1346):1433-43; discussion 1443-4. doi: 10.1098/rstb.1996.0128. — View Citation

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. — View Citation

Saba G, Rocamora JF, Kalalou K, Benadhira R, Plaze M, Aubriot-Delmas B, Januel D. Catatonia and transcranial magnetic stimulation. Am J Psychiatry. 2002 Oct;159(10):1794. doi: 10.1176/appi.ajp.159.10.1794. No abstract available. — View Citation

Sharma A, Choudhury S, Anand N, Grover S, Singh SM. The use of rTMS in an adolescent presenting with acute catatonia: A case report. Asian J Psychiatr. 2018 Oct;37:1-2. doi: 10.1016/j.ajp.2018.07.017. Epub 2018 Aug 2. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Stip E, Lesperance P, Farmer O, Fournier-Gosselin MP. First clinical use of epidural stimulation in catatonia. Brain Stimul. 2017 Jul-Aug;10(4):859-861. doi: 10.1016/j.brs.2017.03.006. Epub 2017 Apr 4. No abstract available. — View Citation

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. — View Citation

Takamiya A, Kishimoto T, Watanabe K, Mimura M, Kito S. Transcranial Magnetic Stimulation for Bipolar Disorder with Catatonic Stupor: A Case Report. Brain Stimul. 2015 Nov-Dec;8(6):1236-7. doi: 10.1016/j.brs.2015.09.004. Epub 2015 Sep 7. No abstract available. — View Citation

Trojak B, Meille V, Bonin B, Chauvet-Geliner JC. Repetitive transcranial magnetic stimulation for the treatment of catatonia: an alternative treatment to electroconvulsive therapy? J Neuropsychiatry Clin Neurosci. 2014 Apr 1;26(2):E42-3. doi: 10.1176/appi.neuropsych.13050102. No abstract available. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of onset of the primary response	Reduction of points on the BPRS and NCRS scales to 70% of the initial	6 months
Primary	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
Primary	The number of patient with the improvement	The total score for BFCRS and NCRS is no more than 3 points	6 months