Brain InjuryNCT00842413
Investigating the Role of the Premotor Cortex in Higher Cognitive Functions
An observational study of Brain Injury and Chronic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Chronic
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Sep 2007
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The visual pereption of subjects willl be studied, but no attempt will be made at modifying it, or treating any problem that they might have.
Who may be able to join
- Healthy subjects chosen from a pool of adult subjects, recruited through ads.
- In the second group, the subjects are recruited from a pool of brain-damaged patients treated at the hospital de la Pitié-Salpétrière. They must suffer from a focal lesion in the prefrontal cortex.
Who cannot join
- For the healthy group: any previous brain-related medical history.
- Widespread brain-damage, extending beyond the prefrontal cortex, that is to say, lesions that are not really focal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Part Does the Premotor Cortex Play in Subjective Visual Perception and in the Perception of Others' Actions?
This project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. It includes a test where we ask subjects to detect visual information in front of a computer screen, and another test where we ask them to imitate finger movements.
Read the detailed description
This project is a twofold exploration of the functions of the premotor cortex, concerning, on the one hand, its role in conscious visual perception, and on the other hand, the part it may play in the perception and imitation of other people's movements. Healthy subjects will be compared with subjects suffering from focal lesions within the premotor cortex, on two tasks: in the first task, the subjects will have to make a decision concerning the absence or presence of a visual item in their field of vision. They will make (virtual) bets based on the subjective certainty of their perceptions - they will be told that these bets are purely virtual, and will not result in any financial gain or loss. This study will help us understand the contribution of the prefrontal cortex to subjective weighing of perceptual certainty. In the second task, the subjects will imitate a finger movement, based either on a fixed picture, or on a short motion picture. Previous studies have shown that whether the movement is copied from a fixed picture or a moving picture changes reaction times and types of mistakes. Neuroimaging studies have shown that a premotor area is involved in this effect. The comparison of brain-damaged and healthy subjects will tell us what exactly the contribution of the prefrontal consists in.
- Conditions
- Brain Injury, Chronic
- Keywords
- Prefrontal cortex, visual consciousness, focal lesions, action perception
- Medical subject headings
- Brain Injuries, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The study compares brain-damaged patients with healthy ones on two psychophysical tasks. | |
| 2 | The study does not intervene on the brain-damaged patients, it merely compares their behaviour with that of healthy patients on a range of psychophysical tasks. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: not enough enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Richard Levy, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842413
- Sponsor's protocol ID
- P060605
- Status last verified
- Nov 2008
- First submitted
- 11 Feb 2009
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Part Does the Premotor Cortex Play in Subjective Visual Perception and in the Perception of Others' Actions?
- ClinicalTrials.gov ID
- NCT00842413
- Acronym / sponsor ID
- P060605
- Conditions
- Brain Injury, Chronic
- Keywords
- Prefrontal cortex, visual consciousness, focal lesions, action perception
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Feb 2009 (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.
This project aims at understanding better the role of the frontal lobe of the brain in our capacity to perceive visual information consciously, and also, in our capacity to perceive others' actions. It includes a test where we ask subjects to detect visual information in front of a computer screen, and another test where we ask them to imitate finger movements.
Detailed description
This project is a twofold exploration of the functions of the premotor cortex, concerning, on the one hand, its role in conscious visual perception, and on the other hand, the part it may play in the perception and imitation of other people's movements. Healthy subjects will be compared with subjects suffering from focal lesions within the premotor cortex, on two tasks: in the first task, the subjects will have to make a decision concerning the absence or presence of a visual item in their field of vision. They will make (virtual) bets based on the subjective certainty of their perceptions - they will be told that these bets are purely virtual, and will not result in any financial gain or loss. This study will help us understand the contribution of the prefrontal cortex to subjective weighing of perceptual certainty. In the second task, the subjects will imitate a finger movement, based either on a fixed picture, or on a short motion picture. Previous studies have shown that whether the movement is copied from a fixed picture or a moving picture changes reaction times and types of mistakes. Neuroimaging studies have shown that a premotor area is involved in this effect. The comparison of brain-damaged and healthy subjects will tell us what exactly the contribution of the prefrontal consists in.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The study compares brain-damaged patients with healthy ones on two psychophysical tasks. |
| 2 | – | –The study does not intervene on the brain-damaged patients, it merely compares their behaviour with that of healthy patients on a range of psychophysical tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The visual pereption of subjects willl be studied, but no attempt will be made at modifying it, or treating any problem that they might have.
Key inclusion criteria (2 listed)
- Healthy subjects chosen from a pool of adult subjects, recruited through ads.
- In the second group, the subjects are recruited from a pool of brain-damaged patients treated at the hospital de la Pitié-Salpétrière. They must suffer from a focal lesion in the prefrontal cortex.
Key exclusion criteria (2 listed)
- For the healthy group: any previous brain-related medical history.
- Widespread brain-damage, extending beyond the prefrontal cortex, that is to say, lesions that are not really focal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: not enough enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
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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.
Richard Levy, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Chronic, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 12 Feb 2009. 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. 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 was stopped early (reason given: not enough enrollment). Results are not available in the source record.
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.
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 12 Feb 2009.