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

Intracranial Hypertension Clinical Trial

— IPCog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976168
• Other study ID #: IPCog
• Status: Completed
• Phase: N/A
• First received: November 18, 2016
• Last updated: March 1, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: DLR German Aerospace Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intracranial Hypertension

Intervention

Other:
• 12° head down tilt
supine head down tilt

Locations

Country	Name	City	State
Germany	DLR German Aerospace Center	Cologne

Sponsors (4)

Lead Sponsor	Collaborator
DLR German Aerospace Center	Forschungszentrum Juelich, University Hospital, Umeå, University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in frontal skin thickness	Conventional Imaging ultrasound will be used to assess Skin thickness at the frontal skull	Once at baseline, and 10 minutes and 19 hours after starting the intervention
Other	Change in arterial blood pressure	arterial blood pressure will be assessed non-invasively from a finger artery during transcranial doppler measurements	Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Other	Change in heart rate	ECG will be recorded during transcranial doppler measurements	Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Primary	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	Change in mid cerebral artery blood flow velocity	Transcranial Doppler measurements	Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Secondary	Change in cerebral tissue oxygenation	Near-infrared measurement	Twice at baseline, and 10 minutes and 19 hours after starting the intervention
Secondary	Magnetic resonance Imaging: Change in cerebral blood flow	Magnetic resonance imaging will be performed in order to gain information about intracranial blood flow.	Once at baseline, and 2 and 19 hours after starting the intervention
Secondary	Magnetic resonance Imaging: Change in resting state functional MRI (fMRI)	Magnetic resonance imaging will be performed to assess resting state functional MRI.	Once at baseline, and 2 and 19 hours after starting the intervention
Secondary	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.	Once at baseline, and 2 and 19 hours after starting the intervention
Secondary	Change in jugular vein filling	Conventional Imaging ultrasound from jugular veins veins will be used to assess vein cross sections	Once at baseline, and 10 minutes and 19 hours after starting the intervention
Secondary	Change in frontal vein filling	Conventional Imaging ultrasound from the frontal veins will be used to assess vein cross sections	Once at baseline, and 10 minutes and 19 hours after starting the intervention
Secondary	Change in P-300	P-300 will be assessed via an EEG electrode during cognitive test battery	Twice at baseline, and 30 minutes and 20 hours after starting the intervention
Secondary	Change in sleep effectiveness	Polysomnographic recordings	over the entire intervention night
Secondary	Change in total sleep time	Polysomnographic recordings	from 22:00 until 6:00 in all nights