Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms (FRS) on Schizophrenia

NCT03284138 | Completed

• 1 other identifier: P150906
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

First rank symptoms are core symptoms of schizophrenia. the investigators want to offer an integrative approach to better understanding of the mechanisms involved in the first rank symptoms and therefore, in schizophrenia, as well as the neuronal modulation mechanisms obtained by rTMS. It will be to pass a functional magnetic resonance imaging (fMRI) at rest for healthy volunteers, and for patients before and after rTMS modulation, to view brain structures activated in the resting state network, and in order to study

1. 1.the difference of the resting-state network between healthy volunteers and people with schizophrenia,
2. 2.if the response to rTMS boost can be predicted by resting-state network of patients before treatment and
3. 3.if rTMS changes activations in the brain of patients. This will ultimately provide rTMS as a treatment of first rank symptoms.

Conditions

Schizophrenia Patients With First Rank Symptoms

Keywords

Schizophrenia; rTMS; first rank symptoms

Outcome Measures

Primary Outcomes (1)

• Evaluation of first rank symptoms

  Number of first rank symptoms measured by items 2,3 and 15 to 19 of "first rank" subscore from SAPS

  5 days after inclusion

Secondary Outcomes (6)

• Evaluation of both agency and sense of body ownership disorders with Rubber Hand Illusion test (RHI)

  5 days, 1 month and 3 months after inclusion

• Evaluation of familiarity disorder

  5 days, 1 and 3 month after inclusion

• Evaluation of the severity of symptoms

  5 days, 1 and 3 month after inclusion

• Evaluation of the functioning

  5 days, 1 and 3 month after inclusion

• Evaluation of quality of life

  5 days, 1 and 3 month after inclusion

Study Arms (2)

rTMS treatment

ACTIVE COMPARATOR

patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)

Device: rTMS treatment

Placebo treatment

SHAM COMPARATOR

patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled

Device: placebo treatment

Interventions

rTMS treatment DEVICE

patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)

Also known as: intervention

rTMS treatment

placebo treatment DEVICE

patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled

Also known as: placebo

Placebo treatment

Eligibility Criteria

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

You may qualify if:

• Suffering from schizophrenia (according to DSM IV-TR)
• Presenting FRS at least once a day despite well-conducted antipsychotic treatment, objectified by FRS subscore of the SAPS (items 2, 3 and items 15-19) with at least two FRS listed \> 1 of the corresponding item of the SAPS
• Being informed of the objectives and constraints of the study and signing the consent form or signing by the guardian
• Patient having had a preliminary clinical examination

You may not qualify if:

• Left-lateralized
• Previously treated with rTMS in the previous 6 month,
• Contraindications of the rTMS practice: unstabilized epilepsy, presence of foreign eye metallic material, pacemaker, neurostimulator, cochlear implants and in general all medical equipment installed immovably, metal heart valve, vascular clips formerly located on cranial aneurysm
• Pregnancy or breastfeeding women
• hospitalization under constraint
• Subject already involved in another interventional clinical research evaluating schizophrenia treatment
• patient with severe drug use disorder (excluding coffee and tobacco) according to the DSM-5 criteria

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Louis Mourier

Colombes, 92700, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Methods

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Aurely Ameller, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 15, 2017
• Study Start: August 3, 2018
• Primary Completion: March 2, 2023
• Study Completion: March 3, 2023
• Last Updated: September 16, 2025

Record last verified: 2023-09

Locations

FR (1)