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"Manual Dexterity and Oculomotor Control in Schizophrenia" (MADOCS)

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ClinicalTrials.gov Identifier: NCT02826629
Recruitment Status : Unknown
Verified October 2017 by Centre Hospitalier St Anne.
Recruitment status was:  Recruiting
First Posted : July 11, 2016
Last Update Posted : October 19, 2017
Sponsor:
Collaborators:
University of Paris 5 - Rene Descartes
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier St Anne

Brief Summary:
The investigators recently showed that visuomotor integration was significantly altered in schizophrenic patients during: (i) a grip force task (Teremetz et al., 2014), and (ii) a saccadic paradigm (oculomotor task)(Amado et al., 2008). Given this findings, the investigators propose a combined study of oculomotor and grip force control to better characterize the sensorimotor integration deficit. This approach may allow for identification of behavioural biomarkers of vulnerability to develop schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Manual dexterity Device: Oculomotor movements Device: TMS coupled to EMG recording Other: Psychopathological evaluations Other: Neuropsychological evaluations Not Applicable

Detailed Description:

1 - Scientific background and rational Use of sensory cues is essential for execution and correction of voluntary movements. The motor areas and their regulation is of special interest in patients with schizophrenia as there is clear evidence of motor abnormalities independent of the effects of antipsychotic medication, even before the onset of the disorder. Sensorimotor abnormalities have been proposed as a valid endophenotype in schizophrenia. Our global objective is to study and provide vulnerability markers for schizophrenia.

  1. Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
  2. Oculomotor movements during behavioral task will be recorded using a video-oculography device
  3. The involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording

2 - Description of the project methodology There is strong evidence for schizophrenia being a neuro-developmental disorder (Rapoport et al., 2005). It has been shown, for many years, that patients with schizophrenia exhibit abnormal patterns of sensorimotor integration (Manschreck et al., 1982), which is the capacity to integrate different sensory stimuli into appropriate motor actions. It is clinically relevant, in terms of early diagnosis and prevention, whether deficient sensorimotor integration is present in the prodromal phase of schizophrenia, and whether this constitutes a vulnerability marker for the disease.

Our global objective is to study the interactions and related substratum of oculomotor movements during force control task.

The secondary objectives:

(i) To show that increased motor noise is indeed present in schizophrenia. (ii) To show by TMS that cortical excitability in the primary motor cortex (M1) is task-modulated and decreased in schizophrenia.

(iii) Assess the role of deficient cortical inhibition in these behavioral deficits To this end, three different groups of subjects will be studied: schizophrenic patients, non-affected siblings, ultra high risk patients, non-treated schizophrenic patients and healthy control subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: "MADOCS: Manual Dexterity and Oculomotor Control as Vulnerability Markers in Schizophrenia"
Actual Study Start Date : July 26, 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Schizophrenia
40 patients with diagnosis of schizophrenia (25 medicated - 15 non-medicated)
Device: Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)

Device: Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography device

Device: TMS coupled to EMG recording
The involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording

Other: Psychopathological evaluations
Other: Neuropsychological evaluations
Healthy sibling
25 healthy siblings
Device: Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)

Device: Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography device

Device: TMS coupled to EMG recording
The involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording

Other: Psychopathological evaluations
Other: Neuropsychological evaluations
Ultra high risk for developing Schizophrenia
15 patients with ultra high risk for developing Schizophrenia
Device: Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)

Device: Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography device

Device: TMS coupled to EMG recording
The involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording

Other: Psychopathological evaluations
Other: Neuropsychological evaluations
Controls
-25 age and gender-matched healthy controls
Device: Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)

Device: Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography device

Device: TMS coupled to EMG recording
The involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording

Other: Psychopathological evaluations
Other: Neuropsychological evaluations



Primary Outcome Measures :
  1. Behavioural assessment [ Time Frame: BASELINE ]
    Index reflecting motor performance during visuomotor task (including force and oculomotor control)


Secondary Outcome Measures :
  1. Clinical scale : PANSS [ Time Frame: BASELINE ]
    Positive and Negative Syndrome Scale: Assess positive and negative symptoms

  2. Clinical scale : DIGS III [ Time Frame: BASELINE ]
    Diagnostic Interview for Genetic Studies 3.0: Overview of clinical state

  3. Clinical scale : BPRS [ Time Frame: BASELINE ]
    Brief Psychiatric Rating Scale: Assess schizophrenic symptoms

  4. Clinical scale : SAS [ Time Frame: BASELINE ]
    Simpson Angus Extra-Pyramidal Scale: Asses extra-pyramidal signs

  5. Clinical scale : AIMS [ Time Frame: BASELINE ]
    Abnormal Involuntary Movements Scale: Assess abnormal involuntary movements

  6. Clinical scale : TAP [ Time Frame: BASELINE ]
    Test battery for Attentional Performance: Assess attentional capacity (e.g. working memory)

  7. Clinical scale : Stroop [ Time Frame: BASELINE ]
    Stroop color naming test: Assess selective attention or inhibition.

  8. Clinical scale : WASI [ Time Frame: BASELINE ]
    Wechsler Abbreviated Scale of Intelligence: Assess intelligence quotient

  9. Tracking performance (motor task): RMS Error [ Time Frame: BASELINE ]
    RMS Error (Root Mean Square)

  10. Tracking performance (motor task): Coefficient of variability [ Time Frame: BASELINE ]
    Coefficient of variability

  11. Tracking performance (motor task): Timing [ Time Frame: BASELINE ]
    Timing/inhibition

  12. Ocolomotor performance (eye tracker) : Saccade [ Time Frame: BASELINE ]
    Saccade error (back up/ catch up saccades) during smooth pursuit and fixation

  13. Ocolomotor performance (eye tracker): Gain [ Time Frame: BASELINE ]
    Gain (target velocity/gaze velocity), Reaction time

  14. Ocolomotor performance (eye tracker): Amplitude of eye movements [ Time Frame: BASELINE ]
    Amplitude (°) and velocity (°/s) of saccadic movements

  15. Motor noise [ Time Frame: BASELINE ]
    Variability of EMG response during visuomotor task

  16. Cortical excitability (MEP; TMS) [ Time Frame: BASELINE ]
    Motor evoked potential (MEP) during visuomotor task (single pulse TMS)

  17. Cortical inhibition (SICI; TMS) [ Time Frame: BASELINE ]
    Cortical inhibition measured during visuomotor task (paired-pulse TMS; MEP)



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.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All groups:

    1. 18>yrs<50
    2. Medical visit completed
    3. Visual acuity (9/10 for each eye or corrected)
    4. Provided written informed consent
  • Group of patient suffering from schizophrenia:

    4. DSM-IV-TR diagnostic criteria for schizophrenia 5. Treatment: stable atypical anti-psychotic medication for >3 months prior to the study

  • Group of UHR patient:

    6. 18>yrs<30 7. Fulfill at risk criteria of CAARMS diagnostic tool

Exclusion Criteria:

• All groups:

  1. IQ<70,
  2. Contraindications for TMS protocol: no previous history of neurosurgery or seizures or 1st degree relative with history of seizures, heart disease, drug abuse or addiction in the last 12 months, medications that lower seizure threshold including clozapine, bupropion, méthadone or theophylline.
  3. Metallic implant in head (except dental fillings)
  4. Pacemaker, or other electronic implanted devices
  5. Central neurological disease: parkinsonism, x
  6. Severe heart attack
  7. Instable clinical state (e.g. stroke)
  8. Previous history of drug abuse lasting more than 5 years or during the last year
  9. Life event with a moderate to severe impact
  10. Caffeine intake in the last two hours preceding visuomotor assessment

    • Groups of Siblings and Healthy controls:

  11. No previous history of psychiatric disease, psychotic spectrum disorder (according to DIGS 3.0)
  12. No previous history of antipsychotic medication (entire life)

    • Groups of UHR patient:

  13. Chlorpromazine dose >100mg over more than 12 weeks
  14. No previous history of autism spectrum disorder, bipolar disorder or diagnozed schizophrenia (according to DSM-IV-TR criteria), isolated anxiety disorders (e.g. social phobia, agoraphobia)

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): NCT02826629


Contacts
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Contact: Isabelle Amado, Dr 00 33 1 45 65 81 79 i.amado@ch-sainte-anne.fr
Contact: Marie GODARD 00 33 1 45 65 77 28 marie.godard@aphp.fr

Locations
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France
Centre de Recherche Clinique (CRC) - CHSA Recruiting
Paris, France, 75014
Contact: Macarena CUENCA       m.cuenca@ch-sainte-anne.fr   
Contact: Cecile Bergot    00 33 1 45 65 84 90    c.bergot@ch-sainte-anne.fr   
Principal Investigator: Macarena CUENCA         
Service Hospitalo-Universitaire (SHU) - CHSA Not yet recruiting
Paris, France, 75014
Contact: Isabelle Amado    00 33 1 45 65 81 79    i.amado@ch-sainte-anne.fr   
Contact: Marie GODARD    00 33 1 45 65 77 28    marie.godard@aphp.fr   
Principal Investigator: Isabelle Amado         
Sponsors and Collaborators
Centre Hospitalier St Anne
University of Paris 5 - Rene Descartes
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Study Director: Isabelle Amado, Dr CHSA
Study Director: Pavel Lindberg, PhD Institut National de la Santé Et de la Recherche Médicale, France
Publications:
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Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT02826629    
Other Study ID Numbers: D16-P01
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier St Anne:
Sensorimotor Integration
Schizophrenia
TMS
Oculomotor
Motor Control
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders