Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284138
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Schizophrenia Patients With First Rank Symptoms Device: rTMS treatment Device: placebo treatment Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms on Schizophrenia: Controlled, Randomised, Double Blind Trial
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : December 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: rTMS treatment
patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)
Device: rTMS treatment
patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)
Other Name: intervention

Sham Comparator: Placebo treatment
patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled
Device: placebo treatment
patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled
Other Name: placebo




Primary Outcome Measures :
  1. Evaluation of first rank symptoms [ Time Frame: 5 days after inclusion ]
    Number of first rank symptoms measured by items 2,3 and 15 to 19 of "first rank" subscore from SAPS


Secondary Outcome Measures :
  1. Evaluation of both agency and sense of body ownership disorders with Rubber Hand Illusion test (RHI) [ Time Frame: 5 days, 1 month and 3 months after inclusion ]

    RHI Test is composite evaluation . A wooden hand will be placed in front of the subject while his proper hand rests, hidden from his vision. When applying identical and synchronous active movement to both the wooden and the subject hidden hand, subject feels rapidly as moving directly to the rubber hand level, and develops a sense of ownership to this artificial hand.

    1. The intensity of the illusion is measured subjectively by answering a questionnaire (over sense of one's own body and agency).
    2. The intensity of the illusion is measured objectively by measuring proprioceptive bias in millimeters after each stimulation by asking the subject to place his own hand after illusion induction.

  2. Evaluation of familiarity disorder [ Time Frame: 5 days, 1 and 3 month after inclusion ]
    Face morphing tasks have been used for a decade to identify facial recognition defects and allow calculating a recognition threshold (percentage of the faces morphed required for recognition). This threshold may be compared over time. Faces are morphed between the subject's face with same sex pictures either familiar (2 persons close to the patient) or unfamiliar (two faces from a database34). The subjects indicate when they recognize their relative or when a stranger emerges during computer presentation of morphed images, to a varying extent from 0 to 100% (by 10% step). A threshold of recognition per conditions (self, familiar, unknown) will be extract for each subject as a percentage

  3. Evaluation of the severity of symptoms [ Time Frame: 5 days, 1 and 3 month after inclusion ]
    use of the Positive And Negative Symptoms Scale PANSS, an hetero evaluation of schizophrenia symptoms

  4. Evaluation of the functioning [ Time Frame: 5 days, 1 and 3 month after inclusion ]
    By using the Global Assessment of Functioning (GAF)

  5. Evaluation of quality of life [ Time Frame: 5 days, 1 and 3 month after inclusion ]
    By using the Shortened Quality of Life Questionnaire (S-QoL 18)

  6. Evaluation of the side effects [ Time Frame: 5 days after inclusion ]
    By using the Side effects surveillance (UKU)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284138


Contacts
Layout table for location contacts
Contact: Aurely Ameller, MD, PhD +331 47 60 64 13 aurely.ameller@aphp.fr
Contact: Caroline Dubertret, MD,Ph D 01 47 60 64 13 caroline.dubertret@aphp.fr

Locations
Layout table for location information
France
Louis Mourier Recruiting
Colombes, France, 92700
Contact: Aurely Ameller, MD, PhD    01 47 60 64 13    aurely.ameller@aphp.fr   
Contact: Caroline Dubertret, MD, PhD    01 47 60 64 13    caroline.dubertret@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Aurely Ameller, MD, PhD Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03284138    
Other Study ID Numbers: P150906 / AOR 15085
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Schizophrenia
rTMS
first rank symptoms
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders