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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"
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: * 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
Age
18 - 35 years
Sex
ALL
Healthy Volunteers
No
"Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia
Moscow, Russia
Start Date
November 1, 2023
Primary Completion Date
May 1, 2024
Completion Date
November 1, 2024
Last Updated
December 19, 2023
60
ESTIMATED participants
rTMS
DIAGNOSTIC_TEST
Placebo
OTHER
Lead Sponsor
Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev
NCT07455929
NCT06740383
Data Source & Attribution
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