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

Primary Purpose

Intracranial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
12° head down tilt
Sponsored by
DLR German Aerospace Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Intracranial Hypertension focused on measuring Cognitive functioning, Brain tissue oxygenation, cerebral perfusion, head down tilt

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts 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.

Sites / Locations

  • DLR German Aerospace Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Horizontal

-12° head down tilt

Arm Description

Subjects will be in horizontal supine Position for 21 hours

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in mid cerebral artery blood flow velocity
Transcranial Doppler measurements
Change in cerebral tissue oxygenation
Near-infrared measurement
Magnetic resonance Imaging: Change in cerebral blood flow
Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.
Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)
Magnetic resonance imaging will be performed to assess resting state functional MRI.
Magnetic resonance Imaging: Change in fMRI Response to decision task
Magnetic resonance imaging will be performed in order to assess functional MRI during a decision task combing a reaction time test using a visual stimulus.
Change in jugular vein filling
Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections
Change in frontal vein filling
Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections
Change in P-300
P-300 will be assessed via an EEG electrode during cognitive test battery
Change in sleep effectiveness
Polysomnographic recordings
Change in total sleep time
Polysomnographic recordings

Full Information

First Posted
November 18, 2016
Last Updated
March 1, 2017
Sponsor
DLR German Aerospace Center
Collaborators
Forschungszentrum Juelich, University Hospital, Umeå, University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02976168
Brief Title
Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
Acronym
IPCog
Official Title
Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DLR German Aerospace Center
Collaborators
Forschungszentrum Juelich, University Hospital, Umeå, University of Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension
Keywords
Cognitive functioning, Brain tissue oxygenation, cerebral perfusion, head down tilt

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Horizontal
Arm Type
No Intervention
Arm Description
Subjects will be in horizontal supine Position for 21 hours
Arm Title
-12° head down tilt
Arm Type
Experimental
Arm Description
Subjects will be in 12° head down supine Position for 21 hours
Intervention Type
Other
Intervention Name(s)
12° head down tilt
Intervention Description
supine head down tilt
Primary Outcome Measure Information:
Title
Change in cognitive test battery score
Description
The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing
Time Frame
Twice at baseline, and 30 minutes and 20 hours after starting the intervention
Secondary Outcome Measure Information:
Title
Change in mid cerebral artery blood flow velocity
Description
Transcranial Doppler measurements
Time Frame
Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Title
Change in cerebral tissue oxygenation
Description
Near-infrared measurement
Time Frame
Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Title
Magnetic resonance Imaging: Change in cerebral blood flow
Description
Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.
Time Frame
Once at baseline, and 2 and 19 hours after starting the intervention
Title
Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)
Description
Magnetic resonance imaging will be performed to assess resting state functional MRI.
Time Frame
Once at baseline, and 2 and 19 hours after starting the intervention
Title
Magnetic resonance Imaging: Change in fMRI Response to decision task
Description
Magnetic resonance imaging will be performed in order to assess functional MRI during a decision task combing a reaction time test using a visual stimulus.
Time Frame
Once at baseline, and 2 and 19 hours after starting the intervention
Title
Change in jugular vein filling
Description
Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections
Time Frame
Once at baseline, and 10 minutes and 19 hours after starting the intervention
Title
Change in frontal vein filling
Description
Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections
Time Frame
Once at baseline, and 10 minutes and 19 hours after starting the intervention
Title
Change in P-300
Description
P-300 will be assessed via an EEG electrode during cognitive test battery
Time Frame
Twice at baseline, and 30 minutes and 20 hours after starting the intervention
Title
Change in sleep effectiveness
Description
Polysomnographic recordings
Time Frame
over the entire intervention night
Title
Change in total sleep time
Description
Polysomnographic recordings
Time Frame
from 22:00 until 6:00 in all nights
Other Pre-specified Outcome Measures:
Title
Change in frontal skin thickness
Description
Conventional Imaging ultrasound will be used to assess Skin thickness at the frontal skull
Time Frame
Once at baseline, and 10 minutes and 19 hours after starting the intervention
Title
Change in arterial blood pressure
Description
arterial blood pressure will be assessed non-invasively from a finger artery during transcranial doppler measurements
Time Frame
Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Title
Change in heart rate
Description
ECG will be recorded during transcranial doppler measurements
Time Frame
Twice at baseline, and 10 minutes and 19 hours after starting the intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörn E Rittweger, MD
Organizational Affiliation
German Aerospace Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
DLR German Aerospace Center
City
Cologne
ZIP/Postal Code
51147
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31040791
Citation
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.
Results Reference
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Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance

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