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

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ClinicalTrials.gov Identifier: NCT02976168
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
Forschungszentrum Juelich
University Hospital, Umeå
University of Cologne
Information provided by (Responsible Party):
DLR German Aerospace Center

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.

Condition or disease Intervention/treatment Phase
Intracranial Hypertension Other: 12° head down tilt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Horizontal
Subjects will be in horizontal supine Position for 21 hours
Experimental: -12° head down tilt
Subjects will be in 12° head down supine Position for 21 hours
Other: 12° head down tilt
supine head down tilt




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in mid cerebral artery blood flow velocity [ Time Frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Transcranial Doppler measurements

  2. Change in cerebral tissue oxygenation [ Time Frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Near-infrared measurement

  3. Magnetic resonance Imaging: Change in cerebral blood flow [ Time Frame: Once at baseline, and 2 and 19 hours after starting the intervention ]
    Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.

  4. Magnetic resonance Imaging: Change in resting state functional MRI (fMRI) [ Time Frame: Once at baseline, and 2 and 19 hours after starting the intervention ]
    Magnetic resonance imaging will be performed to assess resting state functional MRI.

  5. Magnetic resonance Imaging: Change in fMRI Response to decision task [ Time Frame: Once at baseline, and 2 and 19 hours after starting the intervention ]
    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.

  6. Change in jugular vein filling [ Time Frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections

  7. Change in frontal vein filling [ Time Frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections

  8. Change in P-300 [ Time Frame: Twice at baseline, and 30 minutes and 20 hours after starting the intervention ]
    P-300 will be assessed via an EEG electrode during cognitive test battery

  9. Change in sleep effectiveness [ Time Frame: over the entire intervention night ]
    Polysomnographic recordings

  10. Change in total sleep time [ Time Frame: from 22:00 until 6:00 in all nights ]
    Polysomnographic recordings


Other Outcome Measures:
  1. Change in frontal skin thickness [ Time Frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Conventional Imaging ultrasound will be used to assess Skin thickness at the frontal skull

  2. Change in arterial blood pressure [ Time Frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention ]
    arterial blood pressure will be assessed non-invasively from a finger artery during transcranial doppler measurements

  3. Change in heart rate [ Time Frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention ]
    ECG will be recorded during transcranial doppler measurements



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976168


Locations
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Germany
DLR German Aerospace Center
Cologne, Germany, 51147
Sponsors and Collaborators
DLR German Aerospace Center
Forschungszentrum Juelich
University Hospital, Umeå
University of Cologne
Investigators
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Principal Investigator: Jörn E Rittweger, MD German Aerospace Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DLR German Aerospace Center
ClinicalTrials.gov Identifier: NCT02976168    
Other Study ID Numbers: IPCog
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by DLR German Aerospace Center:
Cognitive functioning
Brain tissue oxygenation
cerebral perfusion
head down tilt
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases