SchizophreniaNCT02734927
Motivation and Executive Control in Schizophrenia
A study testing realization of computerized exercises in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial summary
In order to control a behaviour, investigators need to realise goal directed actions and to priories some actions. This control is required in unusual situation. Appropriate actions are selected and coordinated according to context and aim. Several studies try to draw a model of executive function. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- realization of computerized exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to 24 Apr 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years old
- schizophrenia
- french native speaker
Who cannot join
- Neurological disease
- Motor or visual deficit
- Somatic treatment with neurological impact
- Drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
In order to control a behaviour, investigators need to realise goal directed actions and to priories some actions. This control is required in unusual situation. Appropriate actions are selected and coordinated according to context and aim.
Several studies try to draw a model of executive function. Recently, Koechlin has suggested a three levelled organisation to explain how the prefrontal cortex controls actions.
Read more
Contextual control is useful to answer appropriately with the immediate context. Episodic control allows selecting the action according to specific information given before. Sensorial control is the automatic response when a stimulus is presented.
Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal cortex. Chambon and al (2008) have identified a dysfunction of contextual control in schizophrenia.
As the prefrontal cortex is involved in motivational process, it seems interesting to study potential links between executive function and motivation. A study from Kouneiher shows contextual and episodic activation of motivation in healthy population.
Investigators aim to study the way motivational process are recruited in schizophrenia.
Read the detailed description
behavioral protocol. Letters (vowel and consonant; upper- or lower- case) are presented in several colours into successive blocks. Each block included a series of eight letters. Each colour required a specific task given by a fixed rule (contextual control) but for some colour, the rule changes sometimes (episodic control). Participants are informed that payoffs vary according to their own performance. A frame indicates essay with bonus reward. Moreover a dashed frame indicates a low-bonus reward and a solid frame means a high-bonus reward. Thus different blocks are designed: low-incentive block and high incentive block.
This reward increased from standard to bonus motivation in high-incentive block (contextual motivation) and from low to high according to the type of blocks (episodic motivation) Reaction time may be higher in bonus reward Patients with schizophrenia are not sensitive to contextual motivation, and therefore patients should behave differently than control in contextual motivation.
- Conditions
- Schizophrenia
- Being tested
- realization of computerized exercises
- Keywords
- schizophrenia, motivation, executive control
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
realization of computerized exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia group | Active comparator | Schizophrenia patients suffering Receives: Other: realization of computerized exercises |
| control group | Sham comparator | subjects showing no psychological or neurological disorder Receives: Other: realization of computerized exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaction time
reaction time is recorded when the subject press the key (subject should press a key function of the characteristics of the letter submitted)Reaction time should vary with the level of executive control (episodic, contextual, and motivation control (episodic or contextual motivation). Responses will be compared across patients and control.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startNov 2012
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734927
- Sponsor's protocol ID
- 2012-A00026-37
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation and Executive Control in Schizophrenia
- ClinicalTrials.gov ID
- NCT02734927
- Acronym / sponsor ID
- 2012-A00026-37
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, motivation, executive control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 12 Apr 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.
In order to control a behaviour, investigators need to realise goal directed actions and to priories some actions. This control is required in unusual situation. Appropriate actions are selected and coordinated according to context and aim.
Several studies try to draw a model of executive function. Recently, Koechlin has suggested a three levelled organisation to explain how the prefrontal cortex controls actions.
Contextual control is useful to answer appropriately with the immediate context. Episodic control allows selecting the action according to specific information given before. Sensorial control is the automatic response when a stimulus is presented.
Some diseases like schizophrenia are associated with neurological dysfunction in prefrontal cortex. Chambon and al (2008) have identified a dysfunction of contextual control in schizophrenia.
As the prefrontal cortex is involved in motivational process, it seems interesting to study potential links between executive function and motivation. A study from Kouneiher shows contextual and episodic activation of motivation in healthy population.
Investigators aim to study the way motivational process are recruited in schizophrenia.
Detailed description
behavioral protocol. Letters (vowel and consonant; upper- or lower- case) are presented in several colours into successive blocks. Each block included a series of eight letters. Each colour required a specific task given by a fixed rule (contextual control) but for some colour, the rule changes sometimes (episodic control). Participants are informed that payoffs vary according to their own performance. A frame indicates essay with bonus reward. Moreover a dashed frame indicates a low-bonus reward and a solid frame means a high-bonus reward. Thus different blocks are designed: low-incentive block and high incentive block.
This reward increased from standard to bonus motivation in high-incentive block (contextual motivation) and from low to high according to the type of blocks (episodic motivation) Reaction time may be higher in bonus reward Patients with schizophrenia are not sensitive to contextual motivation, and therefore patients should behave differently than control in contextual motivation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia group | Active comparator | Other: realization of computerized exercisesSchizophrenia patients suffering |
| control group | Sham comparator | Other: realization of computerized exercisessubjects showing no psychological or neurological disorder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-45 years old
- schizophrenia
- french native speaker
Key exclusion criteria (4 listed)
- Neurological disease
- Motor or visual deficit
- Somatic treatment with neurological impact
- Drug abuse
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 |
|---|---|---|
| realization of computerized exercises | Other | control group, schizophrenia group |
Primary outcome
reaction time
Time frame: 24 hours
reaction time is recorded when the subject press the key (subject should press a key function of the characteristics of the letter submitted)Reaction time should vary with the level of executive control (episodic, contextual, and motivation control (episodic or contextual motivation). Responses will be compared across patients and control.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing realization of computerized exercises in people with Schizophrenia, run by Hôpital le Vinatier at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reaction time (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2018.