- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02516787
Coherence Between Brain Cortical Function and Neurocognitive Performance During Changed Gravity Conditions (CORTICOG)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Basse-Normandie
-
Caen CEDEX, Basse-Normandie, Frankrike, 14032
- Umr Ucbn/Inserm U1075 Comete
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: EEG and NIRS measurements
|
Electro cortical power in alpha frequency ranges (EEG-LORETA)
Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) - NIRS
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
alterations in brain cortical activity (EEG)
Tidsram: baseline
|
baseline
|
|
brain oxygenation level (NIRS)
Tidsram: baseline
|
baseline
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 10-082
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