Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT06176456
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia
Sponsor:
Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev
Organization:
Study Overview
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"
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECATA
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: