HealthyCORTICOGNCT02516787
Coherence Between Brain Cortical Function and Neurocognitive Performance During Changed Gravity Conditions
A study testing Parabolic flight, EEG measurement and NIRS measurements in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or bone demineralization, extended stays in weightlessness also cause cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Parabolic flight, EEG measurement and NIRS measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers (men or women),
- aged from 18 to 65,
- affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
- who accept to take part in the study,
- who have given their written stated consent,
- who already participated in parabolic flights (even in the same campaign)
- All subjects will pass a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.
Who cannot join
- Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
- Persons with prior serious injuries to their head
- Persons who take any medication or drugs influencing their central nervous system or cognitive performance
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or bone demineralization, extended stays in weightlessness also cause cognitive dysfunction. However, the studies on this subject during space missions short or long term could not determine how these cognitive dysfunction resulted from a direct effect of weightlessness or a stress-related effect.
Analysis of electro-encephalography (EEG) using a standardized mapping method is used to study the changes of operation of the cerebral cortex as the near infrared spectroscopy (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a relatively simple and economical method for studying brain changes in an environment where the normal brain imaging techniques can not be used.
The main objective of this experiment is to evaluate the alterations in brain cortical activity and brain oxygenation level induced by micro- and hypergravity conditions.
- Conditions
- Healthy
- Being tested
- Parabolic flight, EEG measurement, NIRS measurements
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
EEG measurementOther
Electro cortical power in alpha frequency ranges (EEG-LORETA)
NIRS measurementsOther
Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) - NIRS
| Study group | Role | What they receive |
|---|---|---|
| EEG and NIRS measurements | Other | Not described Receives: Other: Parabolic flight; Other: EEG measurement; Other: NIRS measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
alterations in brain cortical activity (EEG)
Measured: baseline
brain oxygenation level (NIRS)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startNov 2010
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516787
- Sponsor's protocol ID
- 10-082
- Acronym
- CORTICOG
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coherence Between Brain Cortical Function and Neurocognitive Performance During Changed Gravity Conditions
- ClinicalTrials.gov ID
- NCT02516787
- Acronym / sponsor ID
- CORTICOG / 10-082
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2013 (actual)
- First posted
- 6 Aug 2015 (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.
Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or bone demineralization, extended stays in weightlessness also cause cognitive dysfunction. However, the studies on this subject during space missions short or long term could not determine how these cognitive dysfunction resulted from a direct effect of weightlessness or a stress-related effect.
Analysis of electro-encephalography (EEG) using a standardized mapping method is used to study the changes of operation of the cerebral cortex as the near infrared spectroscopy (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a relatively simple and economical method for studying brain changes in an environment where the normal brain imaging techniques can not be used.
The main objective of this experiment is to evaluate the alterations in brain cortical activity and brain oxygenation level induced by micro- and hypergravity conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG and NIRS measurements | Other | Other: Parabolic flight, Other: EEG measurement, Other: NIRS measurements |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- healthy volunteers (men or women),
- aged from 18 to 65,
- affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
- who accept to take part in the study,
- who have given their written stated consent,
Key exclusion criteria (4 listed)
- Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
- Persons with prior serious injuries to their head
- Persons who take any medication or drugs influencing their central nervous system or cognitive performance
- Pregnant women.
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 |
|---|---|---|
| Parabolic flight | Other | EEG and NIRS measurements |
| EEG measurementElectro cortical power in alpha frequency ranges (EEG-LORETA) | Other | EEG and NIRS measurements |
| NIRS measurementsBrain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) - NIRS | Other | EEG and NIRS measurements |
Primary outcome
alterations in brain cortical activity (EEG)
Time frame: baseline
brain oxygenation level (NIRS)
Time frame: baseline
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 6 Aug 2015.
Related trials for Healthy
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
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 Parabolic flight, EEG measurement and NIRS measurements in people with Healthy, run by University Hospital, Caen 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 7 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 6 Aug 2015. 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 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?
alterations in brain cortical activity (EEG) (time frame: baseline). The study lists 2 primary outcomes in all. 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 6 Aug 2015.