Trials / Unknown
UnknownNCT06176456
Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia
Interventional Triple-negative Placebo-controlled Personalized Prospective Study "Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia"
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev · Other Government
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | rTMS | Active regiment |
| OTHER | Placebo | Tactile artefacts without magnetic pulses |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-05-01
- Completion
- 2024-11-01
- First posted
- 2023-12-19
- Last updated
- 2023-12-19
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT06176456. Inclusion in this directory is not an endorsement.