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

December 9, 2023 updated by: Moscow Psychiatric Hospital No. 1 Named after N.A. Alexeev

Interventional Triple-negative Placebo-controlled Personalized Prospective Study "Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia"

Evaluation effectiveness and safety of TMS in subjects with catatonia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • "Mental-health Clinic No.1 named N.A.Alexeev of Moscow Health Department" Moscow, Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 sessions with a frequency of 1 Hz
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
Diagnostic test: rTMS
Active regiment
Active Comparator: 10 sessions with a frequency of 20 Hz
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)
Diagnostic test: rTMS
Active regiment
Placebo Comparator: 10 placebo sessions
The coil emits sound and tactile artifacts indistinguishable from therapeutic ones, but without a magnetic pulses.
Other: Placebo
Tactile artefacts without magnetic pulses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of onset of the primary response
Time Frame: 6 months
Reduction of points on the BPRS and NCRS scales to 70% of the initial
6 months
The number of patients with a positive effect of therapy
Time Frame: 6 months
Reduction of the total score on BFCRS and NCRS by at least 50%
6 months
The number of patient with the improvement
Time Frame: 6 months
The total score for BFCRS and NCRS is no more than 3 points
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECATA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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