Treatment of Negative Symptoms of Schizophrenia by rTMS

NCT06595654 | Recruiting

• 1 other identifier: 2021-A02710-40
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).

Conditions

Schizophrenia; Negative Symptoms in Schizophrenia

Keywords

rTMS; TMS; Transcranial magnetic stimulation; naturalistic

Outcome Measures

Primary Outcomes (1)

• Evaluate the efectiveness of rTMS on the negative symptoms of schizophrena, assessed by the SANS ( Scale Assessment Negative Symptoms).

  The SANS is a scale used for negative symptoms that is initially made up of 19 items divided into five sub-scales: emotional blunder, pedigree, avolition-apathy, anhedonia and social withdrawal. Based on the percentage reduction of this score after 2-4 weeks, patients will be allocated according to the following criteria: * Remission: 75% * Effective treatment: 50-74% * Improvement/response: 25-49% * No answer: \<25%

  Baseline (day 1) to end of treatment (2 or 4 weeks)

Secondary Outcomes (9)

• Evaluate the impact of this treatment on general psychopathology assessed by PANSS and CGI.

  Baseline (day 1), end of treatment (2 or 4 weeks), 4 weeks, 12 weeks and 24 weeks after the end of treatment.

• Assess the impact of this treatment on response rate by the SANS

  Baseline (day 1) to end of treatment (2 or 4 weeks)

• Assess the impact of this treatment on the rate of remission by the number of remission with the SANS

  Baseline (day 1) to end of treatment (2 or 4 weeks)

• Assess the impact of this treatment on the relapse rate by the number of relapse with SANS

  4 weeks, 12 weeks and 24 weeks after the end of treatment.

• Assess the impact of this treatment on cognitive symptoms by MOCA (Montreal Cognitive Assessment) and STROOP

  Baseline (day 1) to end of treatment (2 or 4 weeks)

Study Arms (4)

Method 1

OTHER

One stimulation session per day for 20 working days, so 4 weeks (frequency of 10 Hz, 80% 100% of motor threshold). Each session lasts 20 min. The duration of the train is 4 s, an inter-train of 56s.

Other: repetitive Transcranial Magnetic Stimulation

Method 2

OTHER

Two stimulations sessions per day, with 1 hour apart, for 20 working days, so 4 weeks (frequency of 20 Hz, 100% of motor threshold).Each session lasts 28 min. The duration of the train of 10 s, an inter-train of 80s The total number of pulses is 40000 in 20 trains or 2000 per day.

Other: repetitive Transcranial Magnetic Stimulation

Method 3

OTHER

Two stimulations session per day for 10 working days, so 2 weeks. The protocol is delivered in bursts containing 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., 5 Hz). Stimulation intensity is set at 80% of the idle motor threshold intensity

Other: repetitive Transcranial Magnetic Stimulation

Method 4

OTHER

Five to ten sessions per day, 50 minutes apart, with 90% SM for 10 working days, so 2 weeks. 1 of stimuli every 20 ms (50Hz) repeated 3 times, this train itself repeated every 200 ms (5 Hz) or 60 cycles of 10 blocks of 3 stimuli. The duration of the train is 2 seconds with an inter-train of 8 seconds. So there are 1800 stimuli per session

Other: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation OTHER

* Patient is in a chair. * Hearing protection will be implemented. * The corresponding targeting method will be implemented. * The stimulation coil will be set up according to the indications of the targeting method. * A caregiver is present throughout the session. * After the session, the patient is re-assessed clinically for possible adverse effects. * If an adverse reaction is objectified, a doctor on site, is quickly mobilized.

Method 1; Method 2; Method 3; Method 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years of age
• Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
• Stable drug treatment for at least 4 weeks
• Presence or persistence of negative symptoms in the foreground:
• Negative PANSS score ⩾21, positive PANSS score ⩽24
• Patient (or legal representative) willing to participate in the study and having signed an informed consent
• Patient fluent in the French language
• Affiliation to a social security scheme

You may not qualify if:

• Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
• Presence of an unstabilized medical condition
• Pregnant woman
• Woman of childbearing potential and without effective contraception
• Breastfeeding woman

Sponsors & Collaborators

• Centre hospitalier de Ville-Evrard, France: lead

Study Sites (1)

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Dominique Januel

  Clinical research unit, EPS Ville Evrard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef Bencherif

CONTACT

+33 1 43 09 32 32; urc@epsve.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical research unit

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: September 19, 2024
• Study Start: June 9, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)