"Manual Dexterity and Oculomotor Control in Schizophrenia"
NCT ID: NCT02826629
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2016-07-26
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Schizophrenia
40 patients with diagnosis of schizophrenia (25 medicated - 15 non-medicated)
Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography 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
Psychopathological evaluations
Neuropsychological evaluations
Healthy sibling
25 healthy siblings
Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography 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
Psychopathological evaluations
Neuropsychological evaluations
Ultra high risk for developing Schizophrenia
15 patients with ultra high risk for developing Schizophrenia
Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography 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
Psychopathological evaluations
Neuropsychological evaluations
Controls
-25 age and gender-matched healthy controls
Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography 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
Psychopathological evaluations
Neuropsychological evaluations
Interventions
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Manual dexterity
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
Oculomotor movements
Oculomotor movements during behavioral task will be recorded using a video-oculography 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
Psychopathological evaluations
Neuropsychological evaluations
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
50 Years
ALL
Yes
Sponsors
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University of Paris 5 - Rene Descartes
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Centre Hospitalier St Anne
OTHER
Responsible Party
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Principal Investigators
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Isabelle Amado, Dr
Role: STUDY_DIRECTOR
CHSA
Pavel Lindberg, PhD
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Centre de Recherche Clinique (CRC) - CHSA
Paris, , France
Service Hospitalo-Universitaire (SHU) - CHSA
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Macarena CUENCA
Role: primary
Cecile Bergot
Role: backup
Isabelle Amado
Role: primary
Marie GODARD
Role: backup
References
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Teremetz M, Amado I, Bendjemaa N, Krebs MO, Lindberg PG, Maier MA. Deficient grip force control in schizophrenia: behavioral and modeling evidence for altered motor inhibition and motor noise. PLoS One. 2014 Nov 4;9(11):e111853. doi: 10.1371/journal.pone.0111853. eCollection 2014.
Amado I, Landgraf S, Bourdel MC, Leonardi S, Krebs MO. Predictive saccades are impaired in biological nonpsychotic siblings of schizophrenia patients. J Psychiatry Neurosci. 2008 Jan;33(1):17-22.
Other Identifiers
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D16-P01
Identifier Type: -
Identifier Source: org_study_id