SchizophreniaMADOCSNCT02826629
"Manual Dexterity and Oculomotor Control in Schizophrenia"
A study testing Manual dexterity, Oculomotor movements and TMS coupled to EMG recording in people with Schizophrenia, run by Centre Hospitalier St Anne at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Manual dexterity, Oculomotor movements and TMS coupled to EMG recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Jul 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All groups:
- 18>yrs<50
- Medical visit completed
- Visual acuity (9/10 for each eye or corrected)
- Provided written informed consent
- Group of patient suffering from schizophrenia:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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:
- Chlorpromazine dose >100mg over more than 12 weeks
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre de Recherche Clinique (CRC) - CHSA
Paris, 75014
Macarena CUENCA, m.cuenca@ch-sainte-anne.fr
Cecile Bergot, 00 33 1 45 65 84 90, c.bergot@ch-sainte-anne.fr
- Not yet recruiting
Service Hospitalo-Universitaire (SHU) - CHSA
Paris, 75014
Isabelle Amado, 00 33 1 45 65 81 79, i.amado@ch-sainte-anne.fr
Marie GODARD, 00 33 1 45 65 77 28, marie.godard@aphp.fr
About this study
Official title: "MADOCS: Manual Dexterity and Oculomotor Control as Vulnerability Markers in Schizophrenia"
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.
Read the 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.
- Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
- Oculomotor movements during behavioral task will be recorded using a video-oculography device
- 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
- Schizophrenia
- Being tested
- Manual dexterity, Oculomotor movements, TMS coupled to EMG recording, Psychopathological evaluations, Neuropsychological evaluations
- Keywords
- Sensorimotor Integration, Schizophrenia, TMS, Oculomotor, Motor Control
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual dexterityDevice
Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
Oculomotor movementsDevice
Oculomotor movements during behavioral task will be recorded using a video-oculography device
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
Psychopathological evaluationsOther
Neuropsychological evaluationsOther
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | Other | 40 patients with diagnosis of schizophrenia (25 medicated - 15 non-medicated) Receives: Device: Manual dexterity; Device: Oculomotor movements; Device: TMS coupled to EMG recording; Other: Psychopathological evaluations; Other: Neuropsychological evaluations |
| Healthy sibling | Other | 25 healthy siblings Receives: Device: Manual dexterity; Device: Oculomotor movements; Device: TMS coupled to EMG recording; Other: Psychopathological evaluations; Other: Neuropsychological evaluations |
| Ultra high risk for developing Schizophrenia | Other | 15 patients with ultra high risk for developing Schizophrenia Receives: Device: Manual dexterity; Device: Oculomotor movements; Device: TMS coupled to EMG recording; Other: Psychopathological evaluations; Other: Neuropsychological evaluations |
| Controls | Other | -25 age and gender-matched healthy controls Receives: Device: Manual dexterity; Device: Oculomotor movements; Device: TMS coupled to EMG recording; Other: Psychopathological evaluations; Other: Neuropsychological evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural assessment
Index reflecting motor performance during visuomotor task (including force and oculomotor control)
Measured: BASELINE
Secondary outcomes (17)
Clinical scale : PANSS
Positive and Negative Syndrome Scale: Assess positive and negative symptoms
Measured: BASELINE
Clinical scale : DIGS III
Diagnostic Interview for Genetic Studies 3.0: Overview of clinical state
Measured: BASELINE
Clinical scale : BPRS
Brief Psychiatric Rating Scale: Assess schizophrenic symptoms
Measured: BASELINE
Clinical scale : SAS
Simpson Angus Extra-Pyramidal Scale: Asses extra-pyramidal signs
Measured: BASELINE
Clinical scale : AIMS
Abnormal Involuntary Movements Scale: Assess abnormal involuntary movements
Measured: BASELINE
Clinical scale : TAP
Test battery for Attentional Performance: Assess attentional capacity (e.g. working memory)
Measured: BASELINE
Clinical scale : Stroop
Stroop color naming test: Assess selective attention or inhibition.
Measured: BASELINE
Clinical scale : WASI
Wechsler Abbreviated Scale of Intelligence: Assess intelligence quotient
Measured: BASELINE
Tracking performance (motor task): RMS Error
RMS Error (Root Mean Square)
Measured: BASELINE
Tracking performance (motor task): Coefficient of variability
Coefficient of variability
Measured: BASELINE
Tracking performance (motor task): Timing
Timing/inhibition
Measured: BASELINE
Ocolomotor performance (eye tracker) : Saccade
Saccade error (back up/ catch up saccades) during smooth pursuit and fixation
Measured: BASELINE
Ocolomotor performance (eye tracker): Gain
Gain (target velocity/gaze velocity), Reaction time
Measured: BASELINE
Ocolomotor performance (eye tracker): Amplitude of eye movements
Amplitude (°) and velocity (°/s) of saccadic movements
Measured: BASELINE
Motor noise
Variability of EMG response during visuomotor task
Measured: BASELINE
Cortical excitability (MEP; TMS)
Motor evoked potential (MEP) during visuomotor task (single pulse TMS)
Measured: BASELINE
Cortical inhibition (SICI; TMS)
Cortical inhibition measured during visuomotor task (paired-pulse TMS; MEP)
Measured: BASELINE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start26 Jul 2016
- Primary completionSep 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Isabelle Amado, Dr, Study director, CHSAPavel Lindberg, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826629
- Sponsor's protocol ID
- D16-P01
- Acronym
- MADOCS
- Status last verified
- Oct 2017
- First submitted
- 20 May 2016
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25369465Amado 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.
PubMed 18197268
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "MADOCS: Manual Dexterity and Oculomotor Control as Vulnerability Markers in Schizophrenia"
- ClinicalTrials.gov ID
- NCT02826629
- Acronym / sponsor ID
- MADOCS / D16-P01
- Conditions
- Schizophrenia
- Keywords
- Sensorimotor Integration, Schizophrenia, TMS, Oculomotor, Motor Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
- Oculomotor movements during behavioral task will be recorded using a video-oculography device
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | Other | Device: Manual dexterity, Device: Oculomotor movements, Device: TMS coupled to EMG recording, Other: Psychopathological evaluations, Other: Neuropsychological evaluations40 patients with diagnosis of schizophrenia (25 medicated - 15 non-medicated) |
| Healthy sibling | Other | Device: Manual dexterity, Device: Oculomotor movements, Device: TMS coupled to EMG recording, Other: Psychopathological evaluations, Other: Neuropsychological evaluations25 healthy siblings |
| Ultra high risk for developing Schizophrenia | Other | Device: Manual dexterity, Device: Oculomotor movements, Device: TMS coupled to EMG recording, Other: Psychopathological evaluations, Other: Neuropsychological evaluations15 patients with ultra high risk for developing Schizophrenia |
| Controls | Other | Device: Manual dexterity, Device: Oculomotor movements, Device: TMS coupled to EMG recording, Other: Psychopathological evaluations, Other: Neuropsychological evaluations-25 age and gender-matched healthy controls |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- All groups:
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual dexterityControl of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM) | Device | Controls, Healthy sibling, Schizophrenia, Ultra high risk for developing Schizophrenia |
| Oculomotor movementsOculomotor movements during behavioral task will be recorded using a video-oculography device | Device | Controls, Healthy sibling, Schizophrenia, Ultra high risk for developing Schizophrenia |
| TMS coupled to EMG recordingThe involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording | Device | Controls, Healthy sibling, Schizophrenia, Ultra high risk for developing Schizophrenia |
| Psychopathological evaluations | Other | Controls, Healthy sibling, Schizophrenia, Ultra high risk for developing Schizophrenia |
| Neuropsychological evaluations | Other | Controls, Healthy sibling, Schizophrenia, Ultra high risk for developing Schizophrenia |
Primary outcome
Behavioural assessment
Time frame: BASELINE
Index reflecting motor performance during visuomotor task (including force and oculomotor control)
17 secondary outcomes
Clinical scale : PANSS
Time frame: BASELINE
Clinical scale : DIGS III
Time frame: BASELINE
Clinical scale : BPRS
Time frame: BASELINE
Clinical scale : SAS
Time frame: BASELINE
Clinical scale : AIMS
Time frame: BASELINE
Clinical scale : TAP
Time frame: BASELINE
Clinical scale : Stroop
Time frame: BASELINE
Clinical scale : WASI
Time frame: BASELINE
Tracking performance (motor task): RMS Error
Time frame: BASELINE
Tracking performance (motor task): Coefficient of variability
Time frame: BASELINE
Tracking performance (motor task): Timing
Time frame: BASELINE
Ocolomotor performance (eye tracker) : Saccade
Time frame: BASELINE
Ocolomotor performance (eye tracker): Gain
Time frame: BASELINE
Ocolomotor performance (eye tracker): Amplitude of eye movements
Time frame: BASELINE
Motor noise
Time frame: BASELINE
Cortical excitability (MEP; TMS)
Time frame: BASELINE
Cortical inhibition (SICI; TMS)
Time frame: BASELINE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Background: PubMed 25369465Teremetz 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.
- Background: PubMed 18197268Amado 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Amado, Dr study director
CHSA
Pavel Lindberg, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual dexterity, Oculomotor movements and TMS coupled to EMG recording in people with Schizophrenia, run by Centre Hospitalier St Anne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Amado, Dr (00 33 1 45 65 81 79, i.amado@ch-sainte-anne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural assessment (time frame: BASELINE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02826629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.