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

Study Overview
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Brief Summary
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Evaluation effectiveness and safety of TMS in subjects with catatonia

Detailed Description
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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

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

Conditions
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Catatonia, Schizophrenia, Schizo Affective Disorder, Bipolar Affective Disorder

Intervention / Treatment
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* Diagnostic Test: rTMS
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 sessions with a frequency of 1 Hz<br>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<br>* Active regiment<br>|
| Active Comparator: 10 sessions with a frequency of 20 Hz<br>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<br>* Active regiment<br>|
| Placebo Comparator: 10 placebo sessions<br>The coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses. | Other: Placebo<br>* Tactile artefacts without magnetic pulses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |