<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03284138</url>
  </required_header>
  <id_info>
    <org_study_id>P150906 / AOR 15085</org_study_id>
    <nct_id>NCT03284138</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms (FRS) on Schizophrenia</brief_title>
  <acronym>Schirang</acronym>
  <official_title>Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of First Rank Symptoms on Schizophrenia: Controlled, Randomised, Double Blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      First rank symptoms are core symptoms of schizophrenia. the investigators want to offer an&#xD;
      integrative approach to better understanding of the mechanisms involved in the first rank&#xD;
      symptoms and therefore, in schizophrenia, as well as the neuronal modulation mechanisms&#xD;
      obtained by rTMS. It will be to pass a functional magnetic resonance imaging (fMRI) at rest&#xD;
      for healthy volunteers, and for patients before and after rTMS modulation, to view brain&#xD;
      structures activated in the resting state network, and in order to study&#xD;
&#xD;
        1. the difference of the resting-state network between healthy volunteers and people with&#xD;
           schizophrenia,&#xD;
&#xD;
        2. if the response to rTMS boost can be predicted by resting-state network of patients&#xD;
           before treatment and&#xD;
&#xD;
        3. if rTMS changes activations in the brain of patients. This will ultimately provide rTMS&#xD;
           as a treatment of first rank symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizophrenia is a common psychiatric disorder that affects approximately 1% of the general&#xD;
      population. This disease can be described in three dimensions: disorganization, delusions and&#xD;
      negative signs. The &quot;first rank symptoms&quot; (FRS) were first described by Kurt Schneider. These&#xD;
      are core symptoms of schizophrenia that were combined to make pathognomonic signs of the&#xD;
      disease and remain at the center of many classifications of the disease. These symptoms are&#xD;
      voices or thoughts expressed aloud, voices who argue them, voices that comment on behavior or&#xD;
      thoughts, delusional perceptions, experiences of body influences, thoughts influences,&#xD;
      impulses from external influences, the will controlled by external forces, thoughts stolen by&#xD;
      external forces or others, thoughts interferences by other thoughts, publication thoughts.&#xD;
      These symptoms reveal difficulty in distinguishing self and other in action, thought or&#xD;
      physical individual. Thus, the FRS are a gateway to agency disorder, disorder of the sense of&#xD;
      body ownership and familiarity disorder.&#xD;
&#xD;
      Agency is the ability to distinguish ones own actions from those of others. The sense of body&#xD;
      ownership is difficult to distinguish from the sense of agency. It is the knowledge that the&#xD;
      arm (for example) which make this action is mine. A disorder of sense of body ownership may&#xD;
      lead to the illusion of a phantom limb and it is very interesting to separate both mechanisms&#xD;
      of body ownership and agency as wall as the networks involved in agency of those involved in&#xD;
      the sense of body ownership. Familiarity is the feeling associated with the sight of someone&#xD;
      close. Thus, in familiarity disorder, patient recognizes the facial features of relatives,&#xD;
      but feels no sense of familiarity and attributes this to the replacement of the close by an&#xD;
      impostor. Familiarity disorders can be understood through the 2-ways model of faces of&#xD;
      processing in which the ventral pathway would be affected in the familiarity disorder. The&#xD;
      ventral pathway involves a network which extends from the visual cortex to the superior&#xD;
      temporal sulcus, the inferior parietal lobe and the cingulate gyrus to join the dorsal&#xD;
      pathway in the hypothalamus.&#xD;
&#xD;
      In addition, agency studies imply the superior temporal sulcus and the inferior parietal&#xD;
      lobule as regions involved in distinguishing self / others. Nowadays, remains a difficulty to&#xD;
      clearly identify the different functions of the regions involved in agency.&#xD;
&#xD;
      Few neuroimaging studies can identify key areas of the sense of body ownership; in fact,&#xD;
      protocols are difficult to adapt for use in a scanner. However, there are few studies that&#xD;
      highlight, as was expected, extrastriatal body area as well as areas that may be involved in&#xD;
      agency. Experiments have difficulty differentiating, as the investigators said, the sense of&#xD;
      body ownership from agency, but the investigators have a validated tool, the rubber hand&#xD;
      illusion, to differentiate sense of body ownership and agency. This tool has already been&#xD;
      validated in healthy subjects , and was the subject of a study in our unit on patients with&#xD;
      schizophrenia about to be published. In addition, several studies have shown that the&#xD;
      performance at the rubber hand illusion task were modified by repeated Transcranial Magnetic&#xD;
      Stimulation (rTMS) applied to the extrastriatal body area (EBA) or to the inferior parietal&#xD;
      lobule (IPL) or to the temporo-parietal junction (TPJ).&#xD;
&#xD;
      Transcranial magnetic stimulation or TMS modulate cortical excitability without serious side&#xD;
      effects when used at frequencies and intensities recommended in the literature. Low frequency&#xD;
      rTMS is a recognized for treatment-resistant auditory hallucinations in schizophrenia. This&#xD;
      is therefore an interesting therapeutic innovation that will benefit to residual symptoms, in&#xD;
      adjunction to a well conducted medical treatment in schizophrenia.&#xD;
&#xD;
      To our knowledge, no study has been performed using rTMS as a treatment for FRS in&#xD;
      schizophrenia. The investigators propose to evaluate the impact of treatment with&#xD;
      low-frequency rTMS applied to the superior temporal sulcus in its posterior part (pSTS) on&#xD;
      disorders of agency and familiarity. Indeed, it is well established that low-frequency rTMS&#xD;
      (1 Hz) of the left TPJ was used to reduce auditory hallucinations in schizophrenia. On the&#xD;
      same model, the investigators want to offer an innovative and integrative treatment of core&#xD;
      symptoms of schizophrenia with the specificity of not focusing on a single symptom. The&#xD;
      choice of pSTS allows also operating on the sense of body ownership inasmuch the TPJ is&#xD;
      adjacent to the pSTS.&#xD;
&#xD;
      In addition, in order to have a more comprehensive study incorporating different aspects of&#xD;
      the pathophysiology of schizophrenia, the investigators want to add a functional magnetic&#xD;
      resonance imaging (fMRI) of resting-state. This would be to pass a fMRI for healthy&#xD;
      volunteers. For people with schizophrenia, they will pass a fMRI before and after treatment&#xD;
      for visualizing brain structures activated in the resting-state network, in order to study&#xD;
&#xD;
        1. the difference in resting-state circuitry between healthy volunteers and schizophrenia&#xD;
           patients&#xD;
&#xD;
        2. whether the response to treatment with rTMS could be predicted by resting-state network&#xD;
           of patients before treatment and&#xD;
&#xD;
        3. whether treatment with rTMS could modulate brain activations of patients.&#xD;
&#xD;
      Indeed, the resting-state network is the brain activity that occurs when a subject leaves his&#xD;
      mind at rest without any particular task. Self-awareness is involved in this resting-state&#xD;
      network. This network involves bilateral structures with the main nodes in medial prefrontal&#xD;
      cortex, posterior cingulate cortex, precuneus and angular gyrus. People with schizophrenia&#xD;
      exhibit connectivity anomalies in the resting-state network that are temporal connection&#xD;
      anomalies. In acoustico-verbal hallucinations, people with schizophrenia have a resting-state&#xD;
      network particularly active in the auditory cortex. Authors have proposed that this&#xD;
      hyperactivity of the auditory cortex in the resting-state network would make patients more&#xD;
      vulnerable to attribute external stimuli to them.&#xD;
&#xD;
      Similarly, it can be postulated that patients with FRS would have a hyperactivity of the&#xD;
      resting-state network especially in the pSTS and the TPJ, which would lead to a difficulty in&#xD;
      distinguishing oneself and others and thus, to FRS. Thus, the investigators hypothesize that&#xD;
      patients with abnormal functional connectivity in the resting-state network (mainly in the&#xD;
      pSTS and TPJ, which the investigators will then be boost in rTMS) will have a better response&#xD;
      to treatment and that, after rTMS treatment, a change will be visible on neuronal activation&#xD;
      of resting-state network in fMRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2018</start_date>
  <completion_date type="Actual">March 3, 2023</completion_date>
  <primary_completion_date type="Actual">March 2, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of first rank symptoms</measure>
    <time_frame>5 days after inclusion</time_frame>
    <description>Number of first rank symptoms measured by items 2,3 and 15 to 19 of &quot;first rank&quot; subscore from SAPS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of both agency and sense of body ownership disorders with Rubber Hand Illusion test (RHI)</measure>
    <time_frame>5 days, 1 month and 3 months after inclusion</time_frame>
    <description>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.&#xD;
The intensity of the illusion is measured subjectively by answering a questionnaire (over sense of one's own body and agency).&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of familiarity disorder</measure>
    <time_frame>5 days, 1 and 3 month after inclusion</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the severity of symptoms</measure>
    <time_frame>5 days, 1 and 3 month after inclusion</time_frame>
    <description>use of the Positive And Negative Symptoms Scale PANSS, an hetero evaluation of schizophrenia symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the functioning</measure>
    <time_frame>5 days, 1 and 3 month after inclusion</time_frame>
    <description>By using the Global Assessment of Functioning (GAF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of quality of life</measure>
    <time_frame>5 days, 1 and 3 month after inclusion</time_frame>
    <description>By using the Shortened Quality of Life Questionnaire (S-QoL 18)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the side effects</measure>
    <time_frame>5 days after inclusion</time_frame>
    <description>By using the Side effects surveillance (UKU)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Schizophrenia Patients With First Rank Symptoms</condition>
  <arm_group>
    <arm_group_label>rTMS treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>rTMS treatment</intervention_name>
    <description>patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)</description>
    <arm_group_label>rTMS treatment</arm_group_label>
    <other_name>intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>placebo treatment</intervention_name>
    <description>patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled</description>
    <arm_group_label>Placebo treatment</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suffering from schizophrenia (according to DSM IV-TR)&#xD;
&#xD;
          -  Presenting FRS at least once a day despite well-conducted antipsychotic treatment,&#xD;
             objectified by FRS subscore of the SAPS (items 2, 3 and items 15-19) with at least two&#xD;
             FRS listed &gt; 1 of the corresponding item of the SAPS&#xD;
&#xD;
          -  Being informed of the objectives and constraints of the study and signing the consent&#xD;
             form or signing by the guardian&#xD;
&#xD;
          -  Patient having had a preliminary clinical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left-lateralized&#xD;
&#xD;
          -  Previously treated with rTMS in the previous 6 month,&#xD;
&#xD;
          -  Contraindications of the rTMS practice: unstabilized epilepsy, presence of foreign eye&#xD;
             metallic material, pacemaker, neurostimulator, cochlear implants and in general all&#xD;
             medical equipment installed immovably, metal heart valve, vascular clips formerly&#xD;
             located on cranial aneurysm&#xD;
&#xD;
          -  Pregnancy or breastfeeding women&#xD;
&#xD;
          -  hospitalization under constraint&#xD;
&#xD;
          -  Subject already involved in another interventional clinical research evaluating&#xD;
             schizophrenia treatment&#xD;
&#xD;
          -  patient with severe drug use disorder (excluding coffee and tobacco) according to the&#xD;
             DSM-5 criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurely Ameller, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>rTMS</keyword>
  <keyword>first rank symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284138
org study id: P150906 / AOR 15085
nct id: NCT03284138
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Schizophrenia is a common psychiatric disorder that affects approximately 1% of the general
      population. This disease can be described in three dimensions: disorganization, delusions and
      negative signs. The "first rank symptoms" (FRS) were first described by Kurt Schneider. These
      are core symptoms of schizophrenia that were combined to make pathognomonic signs of the
      disease and remain at the center of many classifications of the disease. These symptoms are
      voices or thoughts expressed aloud, voices who argue them, voices that comment on behavior or
      thoughts, delusional perceptions, experiences of body influences, thoughts influences,
      impulses from external influences, the will controlled by external forces, thoughts stolen by
      external forces or others, thoughts interferences by other thoughts, publication thoughts.
      These symptoms reveal difficulty in distinguishing self and other in action, thought or
      physical individual. Thus, the FRS are a gateway to agency disorder, disorder of the sense of
      body ownership and familiarity disorder.

      Agency is the ability to distinguish ones own actions from those of others. The sense of body
      ownership is difficult to distinguish from the sense of agency. It is the knowledge that the
      arm (for example) which make this action is mine. A disorder of sense of body ownership may
      lead to the illusion of a phantom limb and it is very interesting to separate both mechanisms
      of body ownership and agency as wall as the networks involved in agency of those involved in
      the sense of body ownership. Familiarity is the feeling associated with the sight of someone
      close. Thus, in familiarity disorder, patient recognizes the facial features of relatives,
      but feels no sense of familiarity and attributes this to the replacement of the close by an
      impostor. Familiarity disorders can be understood through the 2-ways model of faces of
      processing in which the ventral pathway would be affected in the familiarity disorder. The
      ventral pathway involves a network which extends from the visual cortex to the superior
      temporal sulcus, the inferior parietal lobe and the cingulate gyrus to join the dorsal
      pathway in the hypothalamus.

      In addition, agency studies imply the superior temporal sulcus and the inferior parietal
      lobule as regions involved in distinguishing self / others. Nowadays, remains a difficulty to
      clearly identify the different functions of the regions involved in agency.

      Few neuroimaging studies can identify key areas of the sense of body ownership; in fact,
      protocols are difficult to adapt for use in a scanner. However, there are few studies that
      highlight, as was expected, extrastriatal body area as well as areas that may be involved in
      agency. Experiments have difficulty differentiating, as the investigators said, the sense of
      body ownership from agency, but the investigators have a validated tool, the rubber hand
      illusion, to differentiate sense of body ownership and agency. This tool has already been
      validated in healthy subjects , and was the subject of a study in our unit on patients with
      schizophrenia about to be published. In addition, several studies have shown that the
      performance at the rubber hand illusion task were modified by repeated Transcranial Magnetic
      Stimulation (rTMS) applied to the extrastriatal body area (EBA) or to the inferior parietal
      lobule (IPL) or to the temporo-parietal junction (TPJ).

      Transcranial magnetic stimulation or TMS modulate cortical excitability without serious side
      effects when used at frequencies and intensities recommended in the literature. Low frequency
      rTMS is a recognized for treatment-resistant auditory hallucinations in schizophrenia. This
      is therefore an interesting therapeutic innovation that will benefit to residual symptoms, in
      adjunction to a well conducted medical treatment in schizophrenia.

      To our knowledge, no study has been performed using rTMS as a treatment for FRS in
      schizophrenia. The investigators propose to evaluate the impact of treatment with
      low-frequency rTMS applied to the superior temporal sulcus in its posterior part (pSTS) on
      disorders of agency and familiarity. Indeed, it is well established that low-frequency rTMS
      (1 Hz) of the left TPJ was used to reduce auditory hallucinations in schizophrenia. On the
      same model, the investigators want to offer an innovative and integrative treatment of core
      symptoms of schizophrenia with the specificity of not focusing on a single symptom. The
      choice of pSTS allows also operating on the sense of body ownership inasmuch the TPJ is
      adjacent to the pSTS.

      In addition, in order to have a more comprehensive study incorporating different aspects of
      the pathophysiology of schizophrenia, the investigators want to add a functional magnetic
      resonance imaging (fMRI) of resting-state. This would be to pass a fMRI for healthy
      volunteers. For people with schizophrenia, they will pass a fMRI before and after treatment
      for visualizing brain structures activated in the resting-state network, in order to study

        1. the difference in resting-state circuitry between healthy volunteers and schizophrenia
           patients

        2. whether the response to treatment with rTMS could be predicted by resting-state network
           of patients before treatment and

        3. whether treatment with rTMS could modulate brain activations of patients.

      Indeed, the resting-state network is the brain activity that occurs when a subject leaves his
      mind at rest without any particular task. Self-awareness is involved in this resting-state
      network. This network involves bilateral structures with the main nodes in medial prefrontal
      cortex, posterior cingulate cortex, precuneus and angular gyrus. People with schizophrenia
      exhibit connectivity anomalies in the resting-state network that are temporal connection
      anomalies. In acoustico-verbal hallucinations, people with schizophrenia have a resting-state
      network particularly active in the auditory cortex. Authors have proposed that this
      hyperactivity of the auditory cortex in the resting-state network would make patients more
      vulnerable to attribute external stimuli to them.

      Similarly, it can be postulated that patients with FRS would have a hyperactivity of the
      resting-state network especially in the pSTS and the TPJ, which would lead to a difficulty in
      distinguishing oneself and others and thus, to FRS. Thus, the investigators hypothesize that
      patients with abnormal functional connectivity in the resting-state network (mainly in the
      pSTS and TPJ, which the investigators will then be boost in rTMS) will have a better response
      to treatment and that, after rTMS treatment, a change will be visible on neuronal activation
      of resting-state network in fMRI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Evaluation of first rank symptoms
time frame: 5 days after inclusion
description: Number of first rank symptoms measured by items 2,3 and 15 to 19 of "first rank" subscore from SAPS
measure: 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
description: 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.
The intensity of the illusion is measured subjectively by answering a questionnaire (over sense of one's own body and agency).
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.
measure: Evaluation of familiarity disorder
time frame: 5 days, 1 and 3 month after inclusion
description: 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
measure: Evaluation of the severity of symptoms
time frame: 5 days, 1 and 3 month after inclusion
description: use of the Positive And Negative Symptoms Scale PANSS, an hetero evaluation of schizophrenia symptoms
measure: Evaluation of the functioning
time frame: 5 days, 1 and 3 month after inclusion
description: By using the Global Assessment of Functioning (GAF)
measure: Evaluation of quality of life
time frame: 5 days, 1 and 3 month after inclusion
description: By using the Shortened Quality of Life Questionnaire (S-QoL 18)
measure: Evaluation of the side effects
time frame: 5 days after inclusion
description: By using the Side effects surveillance (UKU)
arm group label: rTMS treatment
arm group type: Active Comparator
description: patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)
arm group label: Placebo treatment
arm group type: Sham Comparator
description: patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled
intervention type: Device
intervention name: rTMS treatment
description: patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)
arm group label: rTMS treatment
other name: intervention
intervention type: Device
intervention name: placebo treatment
description: patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled
arm group label: Placebo treatment
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Aurely Ameller, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: Undecided