An interventional study of rTMS and Placebo in Catatonia, Schizophrenia and Schizo Affective Disorder, sponsored by Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev · Not applicable, Interventional, and Treatment
Evaluation effectiveness and safety of TMS in subjects with catatonia
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:
22 studies on the registry are indexed under Catatonia; 10 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 14 interventional studies indexed under Catatonia.
Browse Catatonia studies →This is the only study on the registry with Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev as lead sponsor.
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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:
Exclusion Criteria:
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 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
The coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses.
Other: Placebo
Active regiment
Tactile artefacts without magnetic pulses
The rate of onset of the primary response
Reduction of points on the BPRS and NCRS scales to 70% of the initial
Time frame: 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%
Time frame: 6 months
The number of patient with the improvement
The total score for BFCRS and NCRS is no more than 3 points
Time frame: 6 months
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