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

NCT ID: NCT02976168

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-11-30

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.

Conditions

Intracranial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Horizontal

Subjects will be in horizontal supine Position for 21 hours

Group Type: NO_INTERVENTION

No interventions assigned to this group

-12° head down tilt

Subjects will be in 12° head down supine Position for 21 hours

Group Type: EXPERIMENTAL

12° head down tilt

Intervention Type: OTHER

supine head down tilt

Interventions

12° head down tilt

supine head down tilt

Intervention Type: OTHER

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Forschungszentrum Juelich

OTHER

Sponsor Role: collaborator

University Hospital, Umeå

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: collaborator

DLR German Aerospace Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jörn E Rittweger, MD

Role: PRINCIPAL_INVESTIGATOR

German Aerospace Center

Locations

DLR German Aerospace Center

Cologne, , Germany

Countries

Germany

References

Boschert AL, Elmenhorst D, Gauger P, Li Z, Garcia-Gutierrez MT, Gerlach D, Johannes B, Zange J, Bauer A, Rittweger J. Sleep Is Compromised in -12 degrees Head Down Tilt Position. Front Physiol. 2019 Apr 16;10:397. doi: 10.3389/fphys.2019.00397. eCollection 2019.

Reference Type: DERIVED

PMID: 31040791 (View on PubMed)

Other Identifiers

IPCog

Identifier Type: -

Identifier Source: org_study_id