Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia

NCT06599372 | Recruiting

• 1 other identifier: 2021-A02698-33
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.

Conditions

Schizophrenia; Transcranial Magnetic Stimulation; Hallucinations, Verbal Auditory

Keywords

hallucinations; resistant auditory hallucinations; schizophrenia; TMS; Transcranial magnetic stimulation; TBS; Theta burst stimulation; a improvement; real-life conditions

Outcome Measures

Primary Outcomes (1)

• The evolution will be evaluated mainly with the AHRS (Auditory Hallucinations Rating Scale)

  Refer to the definition of AHRS above (in Primary Outcome Measure)

  Baseline and at the end of the treatment, also at 1 month and 3 months after the end of the treatment

Secondary Outcomes (7)

• Response rate: a response is defined as a decrease greater than or equal to 30% of total AHRS score from baseline to end of treatment.

  Baseline and at the end of the treatment

• Rate of patients with an end-of-treatment score < 3 on the Positive And Negative Syndrome Scale (PANSS) "Hallucinatory Behavior" item

  Baseline and at the end of the treatment

• Cognitive symptoms: Montreal Cognitive Assessment (MOCA), Stroop

  Baseline and 1 month after the end of treatment

• Addictive attitudes: number of cigarettes/d (tobacco), The Cannabis Abuse Screening Test (CAST), Marijuana Craving Questionnaire (MCQ)

  Baseline and at the end of the treatment

• Mood: Calgary Depression Scale for Schizophrenia (CDSS)

  Baseline and the end of the treatment

Study Arms (2)

The rTMS method

OTHER

The treatment lasts 2 weeks with 20 rTMS sessions at a rate of 2 sessions per day. Each session lasts 20 minutes with a one hour break between sessions. The application of rTMS will be done on the left temporo-parietal junction.

Other: The rTMS method

The cTBS method

OTHER

The treatment lasts 15 days with 45 sessions of cTBS at a rate of 3 sessions per day. The session lasts 40 seconds and consists of 3 pulses at 50Hz repeated every 200 milliseconds (5Hz) to reach a total of 600 pulses, with a 15 minute break between sessions. The application of cTBS will be performed on the left temporo-parietal junction.

Other: The cTBS method

Interventions

The rTMS method OTHER

The patient receives treatment under naturalistic conditions in routine practice.

The rTMS method

The cTBS method OTHER

The patient receives the treatment under naturalistic conditions in routine practice.

The cTBS method

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 DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
• Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
• Patient agreeing to participate in the study and having signed an informed consent
• Patient with French language skills
• Affiliation to a social security system
• Women of childbearing age must be on contraception and have a negative pregnancy test (βHCG)

You may not qualify if:

• Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
• Presence of an unstabilized medical condition
• Pregnant woman (Women of childbearing age without effective contraception)
• Current or less than one month old engagement in another research protocol
• A person who is subject to a safeguard of justice measure
• An adult under curatorship
• Minor patients with mental health problems
• Pregnant or breastfeeding women
• A person in a social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons)
• Persons incapable or unable to give consent

Sponsors & Collaborators

• Dominique JANUEL: lead

Study Sites (1)

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique JANUEL

  Clinical research unit, EPS Ville Evrard

  STUDY DIRECTOR

• Noomane BOUAZIZ

  Clinical research unit, EPS Ville Evrard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcef Bencherif

CONTACT

+33 1 43 09 32 32; urcve1@gmail.com

Rusheentira Thavaseelan

CONTACT

+33 1 43 09 32 32; urcve1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical research unit

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: September 19, 2024
• Study Start: July 11, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)