Bipolar Affective Disorder, Catatonia, Schizo Affective Disorder, Schizophrenia
Conditions
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
Interventions
DIAGNOSTIC_TESTrTMS
Active regiment
OTHERPlacebo
Tactile artefacts without magnetic pulses
Sponsors
Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
The design of the study involves following stages: * diagnostic stage and randomization; * 10 sessions of placebo-controlled stimulation protocols (high- and low-frequency magnetic pulses) * primary 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 stimulation regiment (20 sessions of active neuromodulation) * final analysis of the effectiveness after 20 sessions of TMS and follow-up period (visits after 1 month and 6 months)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of onset of the primary response | 6 months | Reduction of points on the BPRS and NCRS scales to 70% of the initial |
| The number of patients with a positive effect of therapy | 6 months | Reduction of the total score on BFCRS and NCRS by at least 50% |
| The number of patient with the improvement | 6 months | The total score for BFCRS and NCRS is no more than 3 points |
Countries
Russia
Contacts
Primary ContactNatalia Zakharova, MD, PhD
Outcome results
None listed