CatatoniaRECATANCT06176456
Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia
A study testing rTMS in people with Catatonia and Schizophrenia, run by Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev at 1 site in Russia.
Trial summary
Evaluation effectiveness and safety of TMS in subjects with catatonia Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Catatonia, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- rTMS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2023to 1 Nov 2024
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
"Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia
Moscow
About this study
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"
Evaluation effectiveness and safety of TMS in subjects with catatonia
Read the detailed 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
- Being tested
- rTMS, Placebo
- Medical subject headings
- Catatonia, Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDiagnostic test
Active regiment
PlaceboOther
Tactile artefacts without magnetic pulses
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Diagnostic Test: rTMS |
| 10 placebo sessions | Placebo comparator | The coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of onset of the primary response
Reduction of points on the BPRS and NCRS scales to 70% of the initial
Measured: 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%
Measured: 6 months
The number of patient with the improvement
The total score for BFCRS and NCRS is no more than 3 points
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Nov 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for CatatoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Model description
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176456
- Sponsor's protocol ID
- RECATA
- Acronym
- RECATA
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21311482Solmi 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 29140521Oulis 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.
PubMed 8642390Aandi 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.
PubMed 32506001Fink 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.
PubMed 17074935Pommepuy 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.
PubMed 12506260Hirjak 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.
PubMed 31174212Gansler 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.
PubMed 19216060Northoff 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.
PubMed 15279056Structure 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.
PubMed 9729206Rolls 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.
PubMed 8941955Stip 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.
PubMed 29241672Hansbauer 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.
PubMed 32600779Rossi 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.
PubMed 19833552Blumberger 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.
PubMed 29726344
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06176456
- Acronym / sponsor ID
- RECATA / RECATA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Moscow Psychiatric Hospital No. 1 Named after N.A. AlexeevOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation effectiveness and safety of TMS in subjects with catatonia
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 10 sessions with a frequency of 1 Hz | Active comparator | Diagnostic Test: rTMS10 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 |
| 10 sessions with a frequency of 20 Hz | Active comparator | Diagnostic Test: rTMS10 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) |
| 10 placebo sessions | Placebo comparator | Other: PlaceboThe coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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;
- disorganisation of thinking with speech disturbance with verbigerations and/or sperrungs
- hypo- and hyperkinetic psychomotor phenomena;
- substupor without disturbance of consciousness;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSActive regiment | Diagnostic test | 10 sessions with a frequency of 1 Hz, 10 sessions with a frequency of 20 Hz |
| PlaceboTactile artefacts without magnetic pulses | Other | 10 placebo sessions |
Primary outcome
The rate of onset of the primary response
Time frame: 6 months
Reduction of points on the BPRS and NCRS scales to 70% of the initial
The number of patients with a positive effect of therapy
Time frame: 6 months
Reduction of the total score on BFCRS and NCRS by at least 50%
The number of patient with the improvement
Time frame: 6 months
The total score for BFCRS and NCRS is no more than 3 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 21311482Il'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.
- Background: PubMed 29140521Solmi 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.
- Background: PubMed 8642390Oulis 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.
- Background: PubMed 32506001Aandi 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.
- Background: PubMed 17074935Fink 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.
- Background: PubMed 12506260Pommepuy 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.
- Background: PubMed 31174212Hirjak 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.
- Background: PubMed 19216060Gansler 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.
- Background: PubMed 15279056Northoff 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.
- Background: PubMed 9729206Structure 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.
- Background: PubMed 8941955Rolls 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.
- Background: PubMed 29241672Stip 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Catatonia and Schizophrenia, run by Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev at 1 site in Russia.
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 13 inclusion and 7 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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 Natalia Zakharova, MD, PhD (+7 906 052 02 57, nataliza80@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of onset of the primary response (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT06176456, which also lists 23 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 19 Dec 2023.