NCT02826629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

July 26, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

May 20, 2016

Last Update Submit

October 18, 2017

Conditions

Schizophrenia

Keywords

Sensorimotor IntegrationSchizophreniaTMSOculomotorMotor Control

Outcome Measures

Primary Outcomes (1)

  • Behavioural assessment

    Index reflecting motor performance during visuomotor task (including force and oculomotor control)

    BASELINE

Secondary Outcomes (17)

  • Clinical scale : PANSS

    BASELINE

  • Clinical scale : DIGS III

    BASELINE

  • Clinical scale : BPRS

    BASELINE

  • Clinical scale : SAS

    BASELINE

  • Clinical scale : AIMS

    BASELINE

  • +12 more secondary outcomes

Study Arms (4)

Schizophrenia

OTHER

40 patients with diagnosis of schizophrenia (25 medicated - 15 non-medicated)

Device: Manual dexterityDevice: Oculomotor movementsDevice: TMS coupled to EMG recordingOther: Psychopathological evaluationsOther: Neuropsychological evaluations

Healthy sibling

OTHER

25 healthy siblings

Device: Manual dexterityDevice: Oculomotor movementsDevice: TMS coupled to EMG recordingOther: Psychopathological evaluationsOther: Neuropsychological evaluations

Ultra high risk for developing Schizophrenia

OTHER

15 patients with ultra high risk for developing Schizophrenia

Device: Manual dexterityDevice: Oculomotor movementsDevice: TMS coupled to EMG recordingOther: Psychopathological evaluationsOther: Neuropsychological evaluations

Controls

OTHER

-25 age and gender-matched healthy controls

Device: Manual dexterityDevice: Oculomotor movementsDevice: TMS coupled to EMG recordingOther: Psychopathological evaluationsOther: Neuropsychological evaluations

Interventions

Manual dexterityDEVICE

Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)

ControlsHealthy siblingSchizophreniaUltra high risk for developing Schizophrenia
Oculomotor movementsDEVICE

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

ControlsHealthy siblingSchizophreniaUltra high risk for developing Schizophrenia
TMS coupled to EMG recordingDEVICE

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

ControlsHealthy siblingSchizophreniaUltra high risk for developing Schizophrenia
Psychopathological evaluationsOTHER
ControlsHealthy siblingSchizophreniaUltra high risk for developing Schizophrenia
Neuropsychological evaluationsOTHER
ControlsHealthy siblingSchizophreniaUltra high risk for developing Schizophrenia

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All groups:
  • \>yrs\<50
  • Medical visit completed
  • Visual acuity (9/10 for each eye or corrected)
  • Provided written informed consent
  • Group of patient suffering from schizophrenia:
  • \. 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:
  • \. 18\>yrs\<30 7. Fulfill at risk criteria of CAARMS diagnostic tool

You may not qualify if:

  • All groups:
  • IQ\<70,
  • 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.
  • Metallic implant in head (except dental fillings)
  • Pacemaker, or other electronic implanted devices
  • Central neurological disease: parkinsonism, x
  • Severe heart attack
  • Instable clinical state (e.g. stroke)
  • Previous history of drug abuse lasting more than 5 years or during the last year
  • Life event with a moderate to severe impact
  • Caffeine intake in the last two hours preceding visuomotor assessment
  • Groups of Siblings and Healthy controls:
  • No previous history of psychiatric disease, psychotic spectrum disorder (according to DIGS 3.0)
  • No previous history of antipsychotic medication (entire life)
  • Groups of UHR patient:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Recherche Clinique (CRC) - CHSA

Paris, 75014, France

RECRUITING

Service Hospitalo-Universitaire (SHU) - CHSA

Paris, 75014, France

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 25369465BACKGROUND

  • 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.

    PMID: 18197268BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Isabelle Amado, Dr

    CHSA

    STUDY DIRECTOR

  • Pavel Lindberg, PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

Central Study Contacts

Isabelle Amado, Dr

CONTACT

00 33 1 45 65 81 79i.amado@ch-sainte-anne.fr

Marie GODARD

CONTACT

00 33 1 45 65 77 28marie.godard@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

July 11, 2016

Study Start

July 26, 2016

Primary Completion

September 1, 2018

Study Completion

January 1, 2019

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)