Evaluating the effects of noninvasive brain stimulation on catatonia
Interventional Triple-negative Placebo-controlled Personalized Prospective Study "Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia"
This study is testing if a type of brain stimulation can help people with catatonia related to schizophrenia and mood disorders feel better and regain their lost functions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev Government |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06176456 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of transcranial magnetic stimulation (TMS) in patients with catatonia associated with schizophrenia and affective disorders. It involves a diagnostic stage followed by randomization into two personalized stimulation protocols, one delivering high-frequency and the other low-frequency magnetic pulses, with a placebo control group. After an initial analysis post-10 sessions, all participants will receive the most effective protocol for an additional 20 sessions over four weeks, with effectiveness assessed at multiple time points. The goal is to restore lost functions through targeted brain stimulation.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder who exhibit residual catatonia.
Not a fit: Patients with acute hallucinatory-delusional symptoms or those at risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients suffering from catatonia.
How similar studies have performed: While TMS has shown promise in treating various psychiatric conditions, this specific application for catatonia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow
- "Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia — Moscow, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Natalia Zakharova, MD, PhD
- Email: nataliza80@gmail.com
- Phone: +7 906 052 02 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.