Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia (RECATA)

Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev

Status: Enrolling

Conditions: Schizophrenia; Catatonia; Schizo Affective Disorder; Bipolar Affective Disorder

Treatments: Other: Placebo; Diagnostic Test: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06176456

RECATA

Details and patient eligibility

About

Evaluation effectiveness and safety of TMS in subjects with catatonia

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

10 sessions with a frequency of 1 Hz

Active Comparator group

Description:

10 sessions with a frequency of 1 Hz with an amplitude of 120% of the evoked motor response in the projection of the left Dorsolateral prefrontal cortex 1600 pulses per session with total duration of procedure \~ 20 minutes

Treatment:

Diagnostic Test: rTMS

10 sessions with a frequency of 20 Hz

Active Comparator group

Description:

10 sessions with a frequency of 20 Hz with an amplitude of 120% of the evoked motor response in the projection of Dorsolateral prefrontal cortex (1600 pulses per session with total duration of the procedure \~ 20 minutes)

Treatment:

Diagnostic Test: rTMS

10 placebo sessions

Placebo Comparator group

Description:

The coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses.

Treatment:

Other: Placebo