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Completed

NCT Number: NCT02482571

Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia

The primary objective of this research is to measure changes in neurochemical concentrations during stimulation of the primary visual cortex, in both conditions of normoxia (normal oxygen availability) and induced mild hypoxia (reduced oxygen availability).

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Magnetic Resoance Research, University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

The goal is to determine the effect of mild hypoxia on human brain energy metabolism of healthy young adult subjects. For this purpose, the Investigator will utilize non-invasive imaging modalities based on functional magnetic resonance spectroscopy (fMRS) to estimate metabolic changes during a visual stimulus, while subjects are exposed to well-controlled gas mixtures that resembles conditions of either normoxia or mild hypoxia. Identifying the impact of mild hypoxia on functional brain energy metabolism in the healthy human brain is a crucial step for generating hypotheses in multiple patient populations that experience mild hypoxia as consequence of their pathological condition, such as in sleep apnea and traumatic brain injury. The Investigator hypothesize that the energetic demands of neuronal activation as revealed by fMRS will not be affected by mild hypoxia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Those volunteers who are evaluated as normal and not met exclusion criteria will be potential candidates for this study.

Exclusion criteria

  • Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
  • Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
  • Females.
  • Subjects that exhibit noticeable anxiety and/or claustrophobia.
  • Subjects who cannot adhere to the experimental protocol for any reason.
  • Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
  • Subjects who have known conditions which can lead to emergency medical care.
  • Been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, cardiovascular.
  • Been diagnosed by a physician as having respiratory diseases.
  • Had a brain tumor or stroke.
  • Started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain.
  • Had two or more seizures, or been given a diagnosis of epilepsy.
  • Gotten a non-removable piercing or permanent eyeliner.
  • Had a head injury that caused you to lose consciousness for more than 30 minutes or have amnesia for more than 24 hours.
  • Anyone with a history of sleep apnea or head trauma that may have caused Traumatic Brain Injury (TBI).
  • Gotten some type of metal in your body, either from a medical procedure or an injury.
  • Male subjects with long beard which wouldn't allow a complete seal between the mask and the face.
  • Anyone who is not able to see long distance without glasses or contacts.

Treatment and study plan

Mild Hypoxia

Device

During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional magnetic resonance spectroscopy (fMRS) while they are presented with visual stimuli.

Primary outcomes

  1. Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia

    Time frame: Baseline and Visual Stimulation at 4 minutes

    Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of normoxia.

  2. Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia

    Time frame: Baseline and Visual Stimulation at 4 minutes

    Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of hypoxia.

Secondary outcomes

  1. Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia

    Time frame: Baseline and Visual Stimulation at 30 seconds

    Relative change in water signal intensity from rest to visual stimulation as measured by fMRS (without water suppression) in the primary visual cortex during conditions of normoxia.

  2. Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia

    Time frame: Baseline and Visual Stimulation at 30 seconds

    Relative change in water signal intensity from rest to visual stimulation as measured by fMRS (without water suppression) in the primary visual cortex during conditions of hypoxia.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2015
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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