N/A
N=25
Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia
Brain Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT02482571 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
May 2018
Primary outcome: Primary: Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia — 4 percentage of concentration (micromol/g)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mild Hypoxia (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia |
4 | — |
| PRIMARY Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia |
2.9 | — |
| SECONDARY Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia |
3.3 | — |
| SECONDARY Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia |
1.2 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02482571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.