Brain HypoxiaNCT02482571
Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia
A study testing Mild Hypoxia in people with Brain Hypoxia, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Hypoxia
- What is being tested?
- Mild Hypoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2015to 26 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those volunteers who are evaluated as normal and not met exclusion criteria will be potential candidates for this study.
Who cannot join
- 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).
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Magnetic Resoance Research, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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).
Read the detailed description
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.
- Conditions
- Brain Hypoxia
- Being tested
- Mild Hypoxia
- Keywords
- Functional MRS, Glutamate
- Medical subject headings
- Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild HypoxiaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild Hypoxia | Experimental | Subjects are exposed to an intervention that controls the composition of breathed air by using a gas blender (RespirAct). Subjects undergo MRI and MRS while breathing air with both normal oxygen concentration (normoxia) and reduced oxygen concentration (mild hypoxia). Receives: Device: Mild Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia
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.
Measured: Baseline and Visual Stimulation at 4 minutes
Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia
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.
Measured: Baseline and Visual Stimulation at 4 minutes
Secondary outcomes (2)
Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia
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.
Measured: Baseline and Visual Stimulation at 30 seconds
Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia
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.
Measured: Baseline and Visual Stimulation at 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study start13 Aug 2015
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain HypoxiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Mangia, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482571
- Sponsor's protocol ID
- 201503M65382
- Status last verified
- Mar 2019
- First submitted
- 23 Jun 2015
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ho YC, Vidyasagar R, Shen Y, Balanos GM, Golay X, Kauppinen RA. The BOLD response and vascular reactivity during visual stimulation in the presence of hypoxic hypoxia. Neuroimage. 2008 Jun;41(2):179-88. doi: 10.1016/j.neuroimage.2008.02.048. Epub 2008 Mar 6.
PubMed 18396415Tuunanen PI, Murray IJ, Parry NR, Kauppinen RA. Heterogeneous oxygen extraction in the visual cortex during activation in mild hypoxic hypoxia revealed by quantitative functional magnetic resonance imaging. J Cereb Blood Flow Metab. 2006 Feb;26(2):263-73. doi: 10.1038/sj.jcbfm.9600186.
PubMed 16079793
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia
- ClinicalTrials.gov ID
- NCT02482571
- Acronym / sponsor ID
- 201503M65382
- Conditions
- Brain Hypoxia
- Keywords
- Functional MRS, Glutamate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Posted 24 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild Hypoxia | Experimental | Device: Mild HypoxiaSubjects are exposed to an intervention that controls the composition of breathed air by using a gas blender (RespirAct). Subjects undergo MRI and MRS while breathing air with both normal oxygen concentration (normoxia) and reduced oxygen concentration (mild hypoxia). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Those volunteers who are evaluated as normal and not met exclusion criteria will be potential candidates for this study.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| Mild HypoxiaDuring 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. | Device | Mild Hypoxia |
Primary outcome
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.
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.
2 secondary outcomes
Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia
Time frame: Baseline and Visual Stimulation at 30 seconds
Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia
Time frame: Baseline and Visual Stimulation at 30 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18396415Ho YC, Vidyasagar R, Shen Y, Balanos GM, Golay X, Kauppinen RA. The BOLD response and vascular reactivity during visual stimulation in the presence of hypoxic hypoxia. Neuroimage. 2008 Jun;41(2):179-88. doi: 10.1016/j.neuroimage.2008.02.048. Epub 2008 Mar 6.
- Background: PubMed 16079793Tuunanen PI, Murray IJ, Parry NR, Kauppinen RA. Heterogeneous oxygen extraction in the visual cortex during activation in mild hypoxic hypoxia revealed by quantitative functional magnetic resonance imaging. J Cereb Blood Flow Metab. 2006 Feb;26(2):263-73. doi: 10.1038/sj.jcbfm.9600186.
- Profile of Principle InvestigatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Brain Hypoxia
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
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.
Silvia Mangia, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild Hypoxia in people with Brain Hypoxia, run by University of Minnesota at 1 site in United States.
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 1 inclusion and 18 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 19 Mar 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia (time frame: Baseline and Visual Stimulation at 4 minutes). The study lists 2 primary outcomes in all. 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 NCT02482571, which also lists 2 linked publications.
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 19 Mar 2019.