Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance (IPCog)

German Aerospace Center (DLR)

Status

Completed

Conditions

Intracranial Hypertension

Treatments

Other: 12° head down tilt

Study type

Interventional

Funder types

Other

Identifiers

NCT02976168

IPCog

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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
Pronounced orthostatic intolerance (< 10 min standing)
Kidney disorder: deviations from normal values for creatinine in plasma. (Normal value: Creatinine < 1.20 mg/dl)
Thyroid gland disorder: deviations from normal values for thyroid stimulating Hormone (TSH) in plasma. (Normal range: TSH 0.55-4.80 mUnits/l)
Anaemia: Hb under normal values (Normal values of Hb for men: 13.5-17.5 g/l)
Elevated risk of thrombosis
High likelihood of coagulopathy assessed by a clinical standard questionnaire
Chronic back complaints
History of lumbar surgery
History of lumbar spine trauma
Motor or sensory deficits as assessed by neurological examination
Contraindications against MRI
Imprisoned at the time of the study
Taking medications that may impair cognitive function, autonomic function or any of the study procedures
Ophthalmological conditions including glaucoma, retinopathy, severe cataracts, eye trauma or implants
Any other medical condition that the investigators consider a contraindication to the study procedures that would make it unsafe or confound the measurements.