Focus: Healthy Adults Without Brain InjuryNORMALNCT01925963
Normative Datasets for Assessments Planned for Mild Traumatic Brain Injury (NORMAL)
An observational study of Focus: Healthy Adults Without Brain Injury, run by Lindell Weaver at 2 sites in United States.
Trial summary
The purpose of the research study is to collect information about brain function and structure among active duty military personnel or civilians who are healthy. Researchers want to develop a database from normal volunteers that will be used in comparison with a similar database from active duty military with… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Healthy Adults Without Brain Injury
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2014to 6 Jan 2016
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal, healthy, non-brain injured civilians and military participants (active or inactive)
Who may be able to join
- Active duty or civilian in the Colorado Springs area.
- Men 18-65 years old and women 18-35 years old at the time of enrollment.
- Able to speak and read English, as primary language.
- Agrees to, and appears able to participate in all outcome assessments.
- Agrees to provide blood samples for laboratory tests and specimen banking.
- Demonstrates the ability to offer informed consent and signs the study informed consent document.
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- No known brain imaging abnormalities.
- Known history of full term non-complicated birth.
- Estimated glomerular filtration rate (eGFR) >90.
Who cannot join
- Prisoners.
- Pregnant Women.
- Minors.
- Civilian participants with planned leave conflicting with study visits or relocation within 6 months of study enrollment, and unwilling or unable to return for follow up.
- Active duty participants with planned leave or deployment conflicting with assessment intervals.
- Any lifetime history of brain injury.
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- Diagnosis of, or a persistent history of, or symptoms of a neurological disorder (e.g., tinnitus, vertigo, chronic fatigue, numbness, tingling, chronic migraine, fibromyalgia, multiple sclerosis).
- Active therapy for affective disorders, behavioral disorders, or psychological disorders.
- Diagnosis of diabetes mellitus
- Current complaints of brain injury symptoms such as cognitive or affective problems.
- Diagnosis of recurrent migraine or cluster headaches that are under medical management.
- Headaches that occur more than two times per week.
- Recurrent dizziness that requires medical management.
- Dizziness more than two times per week.
- History of theater or war zone activity that placed the participant within a combat zone environment.
- Diagnosis of PTSD or sub-clinical post-traumatic symptoms.
- Known neuroimaging abnormalities.
- Use of daily prescription drugs that could impact a normal outcome (e.g., beta blockers, antidepressants), with the following exceptions:
- Participants who are 45 or more years old may be taking statins or ACE inhibitors.
- Oral or injectable contraceptives are permitted
- Participants <45 years old who are taking any daily prescriptions (exception - oral or injectable contraceptives)
- Known atrial septal defect.
- History of hydrocephalus/microcephaly/macrocephaly.
- History of developmental delay or learning disorder as a child.
- Women who are breastfeeding.
- Women of childbearing potential who do not agree to practice an acceptable form of birth control during the study period.
- Allergy to iodine-based contrast dye (exclusion criteria for neuroimaging assessment measures).
- Those who are unable to participate fully in outcome assessments unless enrollment is reviewed and approved (in writing) by the Study Director.
- Binocular vision not correctable to 20/50.
- Deafness in both ears defined as 90 decibel hearing loss or greater through speech frequencies.
- Anxiety or claustrophobia precluding participation in neuroimaging or vestibular procedures.
- History of therapeutic ionizing radiation to the head.
- Foreign material in head that would interfere with brain imaging.
- Foreign material within the individual that poses risk from MRI.
- History of illicit drug use, except remote, non-habitual use of marijuana.
- History in the last year, of alcohol abuse.
- Current positive urine test for an illicit substance(s).
- Active or prior malignancy except basal cell carcinoma within the last 5 years.
- Unable to abstain from caffeine or tobacco products for at least a 2-hour interval.
- Concurrent enrollment in any other research trial.
- Unable or unwilling to cease participation in sports or activities in which head injury is likely (e.g., mixed martial arts, boxing) during the study period.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Outcomes Assessment Center
Colorado Springs, Colorado, 80906
Evans Army Community Hospital
Colorado Springs, Colorado, 80913
About this study
Official title: Development of Normative Datasets for Assessments Planned for Use in Patients With Mild Traumatic Brain Injury (NORMAL)
The purpose of the research study is to collect information about brain function and structure among active duty military personnel or civilians who are healthy. Researchers want to develop a database from normal volunteers that will be used in comparison with a similar database from active duty military with post-concussive syndrome (PCS) from a mild traumatic brain injury. Findings from this study may be used to design larger studies that will evaluate whether hyperbaric oxygen treatments actually improve PCS.
Participants in this study will undergo numerous tests to assess physical, mental, and intellectual health and how they might change over time. Participants will wear heart and activity monitors, undergo brain imaging, provide blood and urine for laboratory testing, and have vision, hearing, balance, and muscle function tests. They will also complete a number of questionnaires and interviews. This battery of tests will be repeated twice more over the course of 6 months.
Read the detailed description
The primary purpose of this study will develop a database from normal healthy participants for the same outcomes used in a program of studies of hyperbaric oxygen (HBO2) vs. sham control in participants with persistent post-concussive symptoms. This study will characterize the distribution of responses and change in responses over time for each of the outcomes and will examine associations between measures within a given normal participant and across participant characteristics such as age and gender. It will evaluate the test-retest reliability of a series of assessments anticipated for use in the primary, secondary, and exploratory outcomes of this program of studies.
A secondary purpose of this study is to compare normative values to results from randomized exploratory studies of HBO2 vs. sham control in participants with persistent post-concussive symptoms. Also, investigators will examine relationships between outcome measures from normal participants (with respect to clinical equivalence, participant burden, and risk) and compare to associations observed in other studies.
In this study, normal, healthy, non-brain injured civilians and military participants (active or inactive) will undergo a battery of outcome assessments at defined test intervals to replicate the assessment battery used in a program of studies investigating the safety of HBO2 in patients with post-concussive symptoms following mild traumatic brain injury (TBI).
The planned comprehensive assessments will obtain robust neuropsychological, physiological, and neuroimaging data. Other evaluations will include laboratory testing and evaluations of the auditory, vestibular, and visual systems. Neuroimaging (magnetic resonance imaging and computed tomography angiography) will be assessed in participants at baseline and 6 months. Neurological function and electroencephalography (EEG) will be assessed at baseline only. All other in-person outcome measures will be assessed in participants at baseline, at 13 weeks, and 6 months.
- Keywords
- Normal, Traumatic brain injury, Neuroimaging, Hyperbaric oxygen, Neurobehavioral symptom inventory
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal cohort | Normal, healthy adults without history of brain injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropsychological test scores across time
Measured: Baseline and 13 weeks
Secondary outcomes (7)
Change in neuropsychological test scores across time
Measured: Baseline and 6 months
Change in cerebral blood flow by computed tomography angiography
Measured: Baseline and 6 months
Change in brain anatomical structures by quantitative magnetic resonance imaging
Measured: Baseline and 6 months
Change in brain activation by functional magnetic resonance imaging
Measured: Baseline and 6 months
Change in visual refractive error
Measured: Baseline and 13 weeks
Change in visual refractive error
Measured: Baseline and 6 months
Change in sleep quality total score by Pittsburgh Sleep Quality Index
Measured: Baseline and 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study start10 Jan 2014
- Primary completion6 Jan 2016
- Study completion6 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Focus: Healthy Adults Without Brain InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindell Weaver
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, The Emmes Company, LLC, Intermountain Health Care, Inc., Evans Army Community Hospital
- Responsible party
- Sponsor-investigator, Lindell Weaver, Intermountain Health Care, Inc.
- Investigators
- Robert C Price, MD, Principal investigator, Evans Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925963
- Sponsor's protocol ID
- S-11-16
- Acronym
- NORMAL
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2013
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Weaver LK, Cifu D, Hart B, Wolf G, Miller S. Hyperbaric oxygen for post-concussion syndrome: design of Department of Defense clinical trials. Undersea Hyperb Med. 2012 Jul-Aug;39(4):807-14.
PubMed 22908837Wetzel PA, Lindblad AS, Mulatya C, Kannan MA, Villmar Z, Gitchel GT, Weaver LK. Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):299-311.
PubMed 31394600Meehan A, Lewandowski A, Deru K, Hebert D, Weaver LK. Reference ranges and stability of auditory and vestibular measures in a comprehensive assessment battery for traumatic brain injury. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):227-241.
PubMed 31394594Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price R, Williams CS, Orrison WW, Patel JB, Walker JM, Meehan A, Mirow S; NORMAL Study Team. Comprehensive Evaluation of Healthy Volunteers Using Multi-Modality Brain Injury Assessments: An Exploratory, Observational Study. Front Neurol. 2018 Dec 17;9:1030. doi: 10.3389/fneur.2018.01030. eCollection 2018.
PubMed 30631299Walker JM, Mulatya C, Hebert D, Wilson SH, Lindblad AS, Weaver LK. Sleep assessment in a randomized trial of hyperbaric oxygen in U.S. service members with post concussive mild traumatic brain injury compared to normal controls. Sleep Med. 2018 Nov;51:66-79. doi: 10.1016/j.sleep.2018.06.006. Epub 2018 Jun 30.
PubMed 30099354Wetzel PA, Lindblad AS, Raizada H, James N, Mulatya C, Kannan MA, Villamar Z, Gitchel GT, Weaver LK. Eye Tracking Results in Postconcussive Syndrome Versus Normative Participants. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):4011-4019. doi: 10.1167/iovs.18-23815.
PubMed 30098189
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Normative Datasets for Assessments Planned for Use in Patients With Mild Traumatic Brain Injury (NORMAL)
- ClinicalTrials.gov ID
- NCT01925963
- Acronym / sponsor ID
- NORMAL / S-11-16
- Keywords
- Normal, Traumatic brain injury, Neuroimaging, Hyperbaric oxygen, Neurobehavioral symptom inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Lindell WeaverUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, The Emmes Company, LLC, Intermountain Health Care, Inc., Evans Army Community Hospital
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 6 Jan 2016 (actual)
- Study completion
- 6 Jan 2016 (actual)
- First posted
- 20 Aug 2013 (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 purpose of the research study is to collect information about brain function and structure among active duty military personnel or civilians who are healthy. Researchers want to develop a database from normal volunteers that will be used in comparison with a similar database from active duty military with post-concussive syndrome (PCS) from a mild traumatic brain injury. Findings from this study may be used to design larger studies that will evaluate whether hyperbaric oxygen treatments actually improve PCS.
Participants in this study will undergo numerous tests to assess physical, mental, and intellectual health and how they might change over time. Participants will wear heart and activity monitors, undergo brain imaging, provide blood and urine for laboratory testing, and have vision, hearing, balance, and muscle function tests. They will also complete a number of questionnaires and interviews. This battery of tests will be repeated twice more over the course of 6 months.
Detailed description
The primary purpose of this study will develop a database from normal healthy participants for the same outcomes used in a program of studies of hyperbaric oxygen (HBO2) vs. sham control in participants with persistent post-concussive symptoms. This study will characterize the distribution of responses and change in responses over time for each of the outcomes and will examine associations between measures within a given normal participant and across participant characteristics such as age and gender. It will evaluate the test-retest reliability of a series of assessments anticipated for use in the primary, secondary, and exploratory outcomes of this program of studies.
A secondary purpose of this study is to compare normative values to results from randomized exploratory studies of HBO2 vs. sham control in participants with persistent post-concussive symptoms. Also, investigators will examine relationships between outcome measures from normal participants (with respect to clinical equivalence, participant burden, and risk) and compare to associations observed in other studies.
In this study, normal, healthy, non-brain injured civilians and military participants (active or inactive) will undergo a battery of outcome assessments at defined test intervals to replicate the assessment battery used in a program of studies investigating the safety of HBO2 in patients with post-concussive symptoms following mild traumatic brain injury (TBI).
The planned comprehensive assessments will obtain robust neuropsychological, physiological, and neuroimaging data. Other evaluations will include laboratory testing and evaluations of the auditory, vestibular, and visual systems. Neuroimaging (magnetic resonance imaging and computed tomography angiography) will be assessed in participants at baseline and 6 months. Neurological function and electroencephalography (EEG) will be assessed at baseline only. All other in-person outcome measures will be assessed in participants at baseline, at 13 weeks, and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal cohort | – | –Normal, healthy adults without history of brain injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal, healthy, non-brain injured civilians and military participants (active or inactive)
Key inclusion criteria (9 listed)
- Active duty or civilian in the Colorado Springs area.
- Men 18-65 years old and women 18-35 years old at the time of enrollment.
- Able to speak and read English, as primary language.
- Agrees to, and appears able to participate in all outcome assessments.
- Agrees to provide blood samples for laboratory tests and specimen banking.
Key exclusion criteria (41 listed)
- Prisoners.
- Pregnant Women.
- Minors.
- Civilian participants with planned leave conflicting with study visits or relocation within 6 months of study enrollment, and unwilling or unable to return for follow up.
- Active duty participants with planned leave or deployment conflicting with assessment intervals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in neuropsychological test scores across time
Time frame: Baseline and 13 weeks
7 secondary outcomes
Change in neuropsychological test scores across time
Time frame: Baseline and 6 months
Change in cerebral blood flow by computed tomography angiography
Time frame: Baseline and 6 months
Change in brain anatomical structures by quantitative magnetic resonance imaging
Time frame: Baseline and 6 months
Change in brain activation by functional magnetic resonance imaging
Time frame: Baseline and 6 months
Change in visual refractive error
Time frame: Baseline and 13 weeks
Change in visual refractive error
Time frame: Baseline and 6 months
Change in sleep quality total score by Pittsburgh Sleep Quality Index
Time frame: Baseline and 13 weeks
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 27 Aug 2018.
- Background: PubMed 22908837Weaver LK, Cifu D, Hart B, Wolf G, Miller S. Hyperbaric oxygen for post-concussion syndrome: design of Department of Defense clinical trials. Undersea Hyperb Med. 2012 Jul-Aug;39(4):807-14.
- Derived from this study: PubMed 31394600Wetzel PA, Lindblad AS, Mulatya C, Kannan MA, Villmar Z, Gitchel GT, Weaver LK. Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):299-311.
- Derived from this study: PubMed 31394594Meehan A, Lewandowski A, Deru K, Hebert D, Weaver LK. Reference ranges and stability of auditory and vestibular measures in a comprehensive assessment battery for traumatic brain injury. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):227-241.
- Derived from this study: PubMed 30631299Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price R, Williams CS, Orrison WW, Patel JB, Walker JM, Meehan A, Mirow S; NORMAL Study Team. Comprehensive Evaluation of Healthy Volunteers Using Multi-Modality Brain Injury Assessments: An Exploratory, Observational Study. Front Neurol. 2018 Dec 17;9:1030. doi: 10.3389/fneur.2018.01030. eCollection 2018.
- Derived from this study: PubMed 30099354Walker JM, Mulatya C, Hebert D, Wilson SH, Lindblad AS, Weaver LK. Sleep assessment in a randomized trial of hyperbaric oxygen in U.S. service members with post concussive mild traumatic brain injury compared to normal controls. Sleep Med. 2018 Nov;51:66-79. doi: 10.1016/j.sleep.2018.06.006. Epub 2018 Jun 30.
- Derived from this study: PubMed 30098189Wetzel PA, Lindblad AS, Raizada H, James N, Mulatya C, Kannan MA, Villamar Z, Gitchel GT, Weaver LK. Eye Tracking Results in Postconcussive Syndrome Versus Normative Participants. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):4011-4019. doi: 10.1167/iovs.18-23815.
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.
Robert C Price, MD principal investigator
Evans Army Community Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Healthy Adults Without Brain Injury, run by Lindell Weaver at 2 sites 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 9 inclusion and 41 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 neuropsychological test scores across time (time frame: Baseline and 13 weeks). 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 NCT01925963, which also lists 6 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 27 Aug 2018.