Clinical trial NCT06176456: Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia
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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Catatonia
Schizophrenia
Schizo Affective Disorder
Bipolar Affective Disorder
Lead sponsor: Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev
Sponsor class: OTHER_GOV
First posted: 2023-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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)
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: 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

Primary outcomes:
measure: The rate of onset of the primary response
timeFrame: 6 months
measure: The number of patients with a positive effect of therapy
timeFrame: 6 months
measure: The number of patient with the improvement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: "Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia
Study officials:
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