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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 29, 2016
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE March 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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
  • Change in cerebral tissue oxygenation [ Time Frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Near-infrared measurement
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • Change in sleep effectiveness [ Time Frame: over the entire intervention night ]
    Polysomnographic recordings
  • Change in total sleep time [ Time Frame: from 22:00 until 6:00 in all nights ]
    Polysomnographic recordings
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • 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
  • Chance in cerebral tissue oxygenation [ Time Frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Near-infrared measurement
  • Magnetic resonance imaging [ 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 and CSF flow, as well as intracranial structures. Moreover, functional MRI shall be obtained in resting state condition and during a decision task combing a reaction time test using a visual stimulus. Additionally a field mapping sequence for estimating magnetic field inhomogeneities will be acquired.
  • Change in jugular and facial vein filling [ Time Frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention ]
    Conventional Imaging ultrasound from the internal jugular vein, the external jugular vein and facial veins will be used to assess vein cross sections
  • 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
  • Change in sleep effectiveness [ Time Frame: over the entire intervention night ]
    Polysomnographic recordings
  • Change in total sleep time [ Time Frame: from 22:00 until 6:00 in all nights ]
    Polysomnographic recordings
Current Other Pre-specified Outcome Measures
 (submitted: November 23, 2016)
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
Official Title  ICMJE Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Intracranial Hypertension
Intervention  ICMJE Other: 12° head down tilt
supine head down tilt
Study Arms  ICMJE
  • 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
    Intervention: Other: 12° head down tilt
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2016)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02976168
Other Study ID Numbers  ICMJE IPCog
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party DLR German Aerospace Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE DLR German Aerospace Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Forschungszentrum Juelich
  • University Hospital, Umeå
  • University of Cologne
Investigators  ICMJE
Principal Investigator: Jörn E Rittweger, MD German Aerospace Center
PRS Account DLR German Aerospace Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP