Intracranial HypertensionIPCogNCT02976168
Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
A study testing 12° head down tilt in people with Intracranial Hypertension, run by DLR German Aerospace Center at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- 12° head down tilt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 12° head down tilt
- Keywords
- Cognitive functioning, Brain tissue oxygenation, cerebral perfusion, head down tilt
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12° head down tiltOther
supine head down tilt
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 12° head down tilt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive test battery score
The test battery includes sensomotoric speed, psychomotor vigilance, visual analysis of items, abstract thinking and mathematical processing
Measured: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
Secondary outcomes (10)
Change in mid cerebral artery blood flow velocity
Transcranial Doppler measurements
Measured: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Change in cerebral tissue oxygenation
Near-infrared measurement
Measured: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Magnetic resonance Imaging: Change in cerebral blood flow
Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.
Measured: Once at baseline, and 2 and 19 hours after starting the intervention
Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)
Magnetic resonance imaging will be performed to assess resting state functional MRI.
Measured: Once at baseline, and 2 and 19 hours after starting the intervention
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.
Measured: Once at baseline, and 2 and 19 hours after starting the intervention
Change in jugular vein filling
Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections
Measured: Once at baseline, and 10 minutes and 19 hours after starting the intervention
Change in frontal vein filling
Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections
Measured: Once at baseline, and 10 minutes and 19 hours after starting the intervention
Change in P-300
P-300 will be assessed via an EEG electrode during cognitive test battery
Measured: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
Change in sleep effectiveness
Polysomnographic recordings
Measured: over the entire intervention night
Change in total sleep time
Polysomnographic recordings
Measured: from 22:00 until 6:00 in all nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Collaborators
- Forschungszentrum Juelich, University Hospital, Umeå, University of Cologne
- Responsible party
- Sponsor
- Investigators
- Jörn E Rittweger, MD, Principal investigator, German Aerospace Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976168
- Sponsor's protocol ID
- IPCog
- Acronym
- IPCog
- Status last verified
- Mar 2017
- First submitted
- 18 Nov 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 31040791
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
- ClinicalTrials.gov ID
- NCT02976168
- Acronym / sponsor ID
- IPCog / IPCog
- Conditions
- Intracranial Hypertension
- Keywords
- Cognitive functioning, Brain tissue oxygenation, cerebral perfusion, head down tilt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Collaborators
- Forschungszentrum Juelich, University Hospital, Umeå, University of Cologne
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horizontal | No intervention | –Subjects will be in horizontal supine Position for 21 hours |
| -12° head down tilt | Experimental | Other: 12° head down tiltSubjects will be in 12° head down supine Position for 21 hours |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12° head down tiltsupine head down tilt | Other | -12° head down tilt |
Primary outcome
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
10 secondary outcomes
Change in mid cerebral artery blood flow velocity
Time frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Change in cerebral tissue oxygenation
Time frame: Twice at baseline, and 10 minutes and 19 hours after starting the intervention
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: Change in resting state functional MRI (fMRI)
Time frame: Once at baseline, and 2 and 19 hours after starting the intervention
Magnetic resonance Imaging: Change in fMRI Response to decision task
Time frame: Once at baseline, and 2 and 19 hours after starting the intervention
Change in jugular vein filling
Time frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention
Change in frontal vein filling
Time frame: Once at baseline, and 10 minutes and 19 hours after starting the intervention
Change in P-300
Time frame: Twice at baseline, and 30 minutes and 20 hours after starting the intervention
Change in sleep effectiveness
Time frame: over the entire intervention night
Change in total sleep time
Time frame: from 22:00 until 6:00 in all nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 31040791Boschert 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörn E Rittweger, MD principal investigator
German Aerospace Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12° head down tilt in people with Intracranial Hypertension, run by DLR German Aerospace Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive test battery score (time frame: Twice at baseline, and 30 minutes and 20 hours after starting the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.