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

NCT02976168 | Completed

• 1 other identifier: IPCog
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Cognitive functioning; Brain tissue oxygenation; cerebral perfusion; head down tilt

Outcome Measures

Primary Outcomes (1)

• Change in cognitive test battery score

  The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing

  Twice at baseline, and 30 minutes and 20 hours after starting the intervention

Secondary Outcomes (10)

• Change in mid cerebral artery blood flow velocity

  Twice at baseline, and 10 minutes 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

• Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)

  Once at baseline, and 2 and 19 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

Other Outcomes (3)

• Change in frontal skin thickness

  Once at baseline, and 10 minutes and 19 hours after starting the intervention

• Change in arterial blood pressure

  Twice at baseline, and 10 minutes and 19 hours after starting the intervention

• Change in heart rate

  Twice at baseline, and 10 minutes and 19 hours after starting the intervention

Study Arms (2)

Horizontal

NO INTERVENTION

Subjects will be in horizontal supine Position for 21 hours

-12° head down tilt

EXPERIMENTAL

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

Other: 12° head down tilt

Interventions

12° head down tilt OTHER

supine head down tilt

-12° head down tilt

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DLR German Aerospace Center: lead
• Forschungszentrum Juelich: collaborator
• University Hospital, Umeå: collaborator
• University of Cologne: collaborator

Study Sites (1)

DLR German Aerospace Center

Cologne, 51147, Germany

Location

Related Publications (1)

• 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.

  PMID: 31040791 DERIVED

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jörn E Rittweger, MD

  German Aerospace Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 29, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

DE (1)