Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Hypertension
- Sponsor
- DLR German Aerospace Center
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Change in cognitive test battery score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of the study is to understand the relationship between intracranial pressure regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the study tests the hypothesis that head down tilt will increase intracranial pressure (not measured in this study, but demonstrated in previous studies), will induce venous congestion and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning. The objectives of the study therefore are to assess young healthy people during head-down tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via event-related potentials.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Physically and mentally healthy male test subjects that are able and declare in writing their willingness to participate in the entire study and successfully passed the psychological and medical screening
- •Aged between 18-55 years old with a Body Mass Index (BMI) of 20-28 kg/m2, weight between 65-100 kg, and a height between 158-195 cm
- •Demonstrable medical insurance and official certificate of absence of criminal record
Exclusion Criteria
- •Inability to sleep on the back
- •Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
- •Smoking within the past 6 months prior to study commencement
- •Migraine or other chronic head aches
- •Previous psychiatric illness
- •Subjects suffering from weak concentration
- •History of psychological or central nervous disorders
- •Hiatus hernia
- •Gastro-oesophageal reflux
- •Diabetes mellitus
Outcomes
Primary Outcomes
Change in cognitive test battery score
Time Frame: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing
Secondary Outcomes
- Change in total sleep time(from 22:00 until 6:00 in all nights)
- Change in mid cerebral artery blood flow velocity(Twice at baseline, and 10 minutes and 19 hours after starting the intervention)
- Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)(Once at baseline, and 2 and 19 hours after starting the intervention)
- Change in P-300(Twice at baseline, and 30 minutes and 20 hours after starting the intervention)
- Magnetic resonance Imaging: Change in fMRI Response to decision task(Once at baseline, and 2 and 19 hours after starting the intervention)
- Change in cerebral tissue oxygenation(Twice at baseline, and 10 minutes and 19 hours after starting the intervention)
- Magnetic resonance Imaging: Change in cerebral blood flow(Once at baseline, and 2 and 19 hours after starting the intervention)
- Change in frontal vein filling(Once at baseline, and 10 minutes and 19 hours after starting the intervention)
- Change in jugular vein filling(Once at baseline, and 10 minutes and 19 hours after starting the intervention)
- Change in sleep effectiveness(over the entire intervention night)