Concussion Post SyndromeNCT03355339
The Effect of Binasal Occlusion on Balance Following a Concussion
A study testing Binasal occlusion and No binasal occlusion in people with Concussion Post Syndrome, run by University of Ottawa.
Trial summary
This study evaluates the effect of binasal occlusion (BNO) glasses on balance and eye movement in adults with dizziness after a concussion. Participants will stand on a force plate while rapidly reading a series of numbers both with and without the BNO glasses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Concussion Post Syndrome
- What is being tested?
- Binasal occlusion and No binasal occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Sep 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forty adults with persistent symptoms one month or more following a concussion will be recruited for the study. Individuals will be considered eligible if they have been diagnosed with a concussion as defined in the 2016 Berlin consensus statement (McCrory et al., 2017) as a traumatic brain injury induced by biomechanics forces, which was caused by either a direct or indirect blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head, which may or may not have involved loss of consciousness, and included one or more of the following clinical domains:
- Symptoms (e.g. headache, nausea, fatigue, feeling like in a fog, difficulty concentrating or remembering, and/or emotional lability)
- Physical signs (e.g. loss of consciousness, amnesia, neurological deficit);
- Balance impairment (e.g. gait unsteadiness)
- Behavioural changes (e.g. irritability)
- Cognitive impairment (e.g. slowed reaction times)
- Sleep/wake disturbance (e.g. somnolence, drowsiness) Participants must also meet the following inclusion criteria: (1) aged 18-65 years; (2) sustained the concussion 4 or more weeks ago; (3) report persistent dizziness or balance problems not accounted for by a pre-existing musculoskeletal, neurological, or vestibular condition; (4) have normal vision or visual impairments that can be corrected with contact lenses; (5) are proficient in English or French; (6) are able to provide informed consent.
Who cannot join
- Do not meet criteria stipulated in the inclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates the effect of binasal occlusion (BNO) glasses on balance and eye movement in adults with dizziness after a concussion. Participants will stand on a force plate while rapidly reading a series of numbers both with and without the BNO glasses. It is thought that the BNO glasses will improve both balance and the time to read the numbers.
Read the detailed description
While most individuals will recover within the first month after concussion, a significant number will continue to experience dizziness, balance problems, cognitive deficits, and vision problems. Single-task measures of static balance may not be sensitive enough, however, to capture mild postural changes still associated with incomplete recovery. Increasingly there is an interest in dual-task paradigms of balance assessment as a more accurate representation of functional postural control associated with activities of daily living and sport participation. Binasal occlusion (BNO) has been proposed as a means of providing visual stabilization to improve postural control in individuals with vision-related balance problems following a concussion.
- Conditions
- Concussion Post Syndrome
- Being tested
- Binasal occlusion, No binasal occlusion
- Keywords
- Balance, Dual-task, King-Devick Test, Saccades, Binasal Occlusion
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binasal occlusionDevice
Binasal occlusion glasses
No binasal occlusionDevice
Non-occluded glasses
| Study group | Role | What they receive |
|---|---|---|
| Binasal occlusion | Experimental | Participants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens. Receives: Device: Binasal occlusion |
| No binasal occlusion | Active comparator | Participants will be fitted with non-occluded glasses. Receives: Device: No binasal occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway
The primary outcome of interest is the mean medial/lateral and anterior/posterior velocity of centre of pressure, in addition to the 95% ellipse during different conditions of static balance. The minimal clinical difference considered to demonstrate a change in postural sway is 5cm based on previous validation of the Balance TrackS force plate in a concussed population.
Measured: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Secondary outcomes (5)
Time to completion of the King-Devick Test (KDT)
The KDT is a vision-based test of rapid number naming speed that acts as a proxy measure for saccadic eye movement. The KDT consists of a demonstration card, plus a series of 3 increasingly more difficult test cards of variably spaced single digit numbers. Following completion of the demonstration card, participants are asked to read each test card from left to right, top to bottom, as quickly as possible without errors. A summary score of the test is recorded as the total time to complete all 3 test cards, measured in seconds. Time to completion for the KDT will be recorded. Any increase in time compared with a control condition, or any uncorrected errors are considered a significant change.
Measured: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Saccadic eye movement
Saccadic eye movement will be assessed with a Tobii™ Pro wearable eye tracker. Tobii™ Pro wearable eye tracker uses infrared video-oculography to analyze patterns of eye movement in terms of fixations and saccades. Longer, more complicated visual tasks, such as rapid number naming, require longer processing times. The number of saccades completed during each balance condition will be recorded by the Tobii™ Pro.
Measured: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Post-concussion symptom score (PCSS)
The PCSS is a standardized and easily administered 22-item self-report symptom scale that measures the severity of each symptom experienced that day. Symptoms are reported on a 7-point Likert scale, with 0 and 6 representing anchoring points from the absence of symptoms to the presence of severe symptoms. Results are conveyed as the total symptom score and range from 0-132, with a higher score associated with a higher level of symptoms. Total scores demonstrate high internal consistency in a concussion population (α=0.93), with a 6.8 point change (80% CI) associated with a clinical change in symptoms.
Measured: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Neck Disability Index (NDI)
The NDI is the most commonly used self-report outcome measure for neck pain. The index is a simple and quickly administered 10-item questionnaire measured on a 6-point Likert scale from 0=no disability to 5 = full disability. Scores range from 0-50, with 50 representing the highest level of disability. Clinically important difference have been reported with a 5-7 point change in score depending on whether the pain was of musculoskeletal or neural origin.
Measured: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Dizziness Handicap Inventory (DHI)
The DHI is a self-report measure of disability associated with dizziness. Internal consistency is high for total scores (α = 0.89). The presence of dizziness-related disability is scored as no (0), sometimes (2), or yes (4). Scores range from 0-100, with a higher score reflecting a greater disability associated with dizziness. Cut-off scores exist for mild (16-34), moderate (36-52), and severe (54+) disability, with an 18-point change in score considered clinically meaningful.
Measured: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startNov 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Concussion Post SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacquie van Ierssel, University of Ottawa
- Investigators
- Heidi Sveistrup, PhD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355339
- Sponsor's protocol ID
- H06-17-20
- Status last verified
- Oct 2018
- First submitted
- 9 Nov 2017
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Broglio SP, Tomporowski PD, Ferrara MS. Balance performance with a cognitive task: a dual-task testing paradigm. Med Sci Sports Exerc. 2005 Apr;37(4):689-95. doi: 10.1249/01.mss.0000159019.14919.09.
PubMed 15809571Chang JO, Levy SS, Seay SW, Goble DJ. An alternative to the balance error scoring system: using a low-cost balance board to improve the validity/reliability of sports-related concussion balance testing. Clin J Sport Med. 2014 May;24(3):256-62. doi: 10.1097/JSM.0000000000000016.
PubMed 24284947Ciuffreda KJ, Yadav NK, Ludlam DP. Effect of binasal occlusion (BNO) on the visual-evoked potential (VEP) in mild traumatic brain injury (mTBI). Brain Inj. 2013;27(1):41-7. doi: 10.3109/02699052.2012.700088. Epub 2012 Aug 17.
PubMed 22900490Ciuffreda KJ, Yadav NK, Ludlam DP. Binasal Occlusion (BNO), Visual Motion Sensitivity (VMS), and the Visually-Evoked Potential (VEP) in mild Traumatic Brain Injury and Traumatic Brain Injury (mTBI/TBI). Brain Sci. 2017 Aug 9;7(8):98. doi: 10.3390/brainsci7080098.
PubMed 28792441Degani AM, Santos MM, Leonard CT, Rau TF, Patel SA, Mohapatra S, Danna-Dos-Santos A. The effects of mild traumatic brain injury on postural control. Brain Inj. 2017;31(1):49-56. doi: 10.1080/02699052.2016.1225982. Epub 2016 Dec 12.
PubMed 27936960Galetta KM, Liu M, Leong DF, Ventura RE, Galetta SL, Balcer LJ. The King-Devick test of rapid number naming for concussion detection: meta-analysis and systematic review of the literature. Concussion. 2015 Sep 10;1(2):CNC8. doi: 10.2217/cnc.15.8. eCollection 2016 Mar.
PubMed 30202552Galetta KM, Morganroth J, Moehringer N, Mueller B, Hasanaj L, Webb N, Civitano C, Cardone DA, Silverio A, Galetta SL, Balcer LJ. Adding Vision to Concussion Testing: A Prospective Study of Sideline Testing in Youth and Collegiate Athletes. J Neuroophthalmol. 2015 Sep;35(3):235-41. doi: 10.1097/WNO.0000000000000226.
PubMed 25742059Gallop S. A variation on the use of binasal occlusion glasses - a case study. Journal of Behavioural Optometry 9(2): 31-35, 1998.
Gallop S. Viewpoint 4 Binasal Occlusion - Immediate , Sustainable Symptomatic Relief. Optometry & Visual Performance 9(2):31-35, 2014.
Goble DJ, Manyak KA, Abdenour TE, Rauh MJ, Baweja HS. AN INITIAL EVALUATION OF THE BTRACKS BALANCE PLATE AND SPORTS BALANCE SOFTWARE FOR CONCUSSION DIAGNOSIS. Int J Sports Phys Ther. 2016 Apr;11(2):149-55.
PubMed 27104048Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
PubMed 2317323Hunt AW, Mah K, Reed N, Engel L, Keightley M. Oculomotor-Based Vision Assessment in Mild Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2016 Jul-Aug;31(4):252-61. doi: 10.1097/HTR.0000000000000174.
PubMed 26291632Kamins J, Bigler E, Covassin T, Henry L, Kemp S, Leddy JJ, Mayer A, McCrea M, Prins M, Schneider KJ, Valovich McLeod TC, Zemek R, Giza CC. What is the physiological time to recovery after concussion? A systematic review. Br J Sports Med. 2017 Jun;51(12):935-940. doi: 10.1136/bjsports-2016-097464. Epub 2017 Apr 28.
PubMed 28455363Kleffelgaard I, Roe C, Soberg HL, Bergland A. Associations among self-reported balance problems, post-concussion symptoms and performance-based tests: a longitudinal follow-up study. Disabil Rehabil. 2012;34(9):788-94. doi: 10.3109/09638288.2011.619624. Epub 2011 Dec 9.
PubMed 22149161Lau BC, Kontos AP, Collins MW, Mucha A, Lovell MR. Which on-field signs/symptoms predict protracted recovery from sport-related concussion among high school football players? Am J Sports Med. 2011 Nov;39(11):2311-8. doi: 10.1177/0363546511410655. Epub 2011 Jun 28.
PubMed 21712482
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Binasal Occlusion on Balance Following a Concussion
- ClinicalTrials.gov ID
- NCT03355339
- Acronym / sponsor ID
- H06-17-20
- Conditions
- Concussion Post Syndrome
- Keywords
- Balance, Dual-task, King-Devick Test, Saccades, Binasal Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 28 Nov 2017 (actual)
- 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.
This study evaluates the effect of binasal occlusion (BNO) glasses on balance and eye movement in adults with dizziness after a concussion. Participants will stand on a force plate while rapidly reading a series of numbers both with and without the BNO glasses. It is thought that the BNO glasses will improve both balance and the time to read the numbers.
Detailed description
While most individuals will recover within the first month after concussion, a significant number will continue to experience dizziness, balance problems, cognitive deficits, and vision problems. Single-task measures of static balance may not be sensitive enough, however, to capture mild postural changes still associated with incomplete recovery. Increasingly there is an interest in dual-task paradigms of balance assessment as a more accurate representation of functional postural control associated with activities of daily living and sport participation. Binasal occlusion (BNO) has been proposed as a means of providing visual stabilization to improve postural control in individuals with vision-related balance problems following a concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binasal occlusion | Experimental | Device: Binasal occlusionParticipants will be fitted with glasses covered with occlusive tape from the inner canthi to the nasal border on each lens. |
| No binasal occlusion | Active comparator | Device: No binasal occlusionParticipants will be fitted with non-occluded glasses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Forty adults with persistent symptoms one month or more following a concussion will be recruited for the study. Individuals will be considered eligible if they have been diagnosed with a concussion as defined in the 2016 Berlin consensus statement (McCrory et al., 2017) as a traumatic brain injury induced by biomechanics forces, which was caused by either a direct or indirect blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head, which may or may not have involved loss of consciousness, and included one or more of the following clinical domains:
- Symptoms (e.g. headache, nausea, fatigue, feeling like in a fog, difficulty concentrating or remembering, and/or emotional lability)
- Physical signs (e.g. loss of consciousness, amnesia, neurological deficit);
- Balance impairment (e.g. gait unsteadiness)
- Behavioural changes (e.g. irritability)
Key exclusion criteria (1 listed)
- Do not meet criteria stipulated in the inclusion criteria
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 |
|---|---|---|
| Binasal occlusionBinasal occlusion glasses | Device | Binasal occlusion |
| No binasal occlusionNon-occluded glasses | Device | No binasal occlusion |
Primary outcome
Postural sway
Time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
The primary outcome of interest is the mean medial/lateral and anterior/posterior velocity of centre of pressure, in addition to the 95% ellipse during different conditions of static balance. The minimal clinical difference considered to demonstrate a change in postural sway is 5cm based on previous validation of the Balance TrackS force plate in a concussed population.
5 secondary outcomes
Time to completion of the King-Devick Test (KDT)
Time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Saccadic eye movement
Time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Post-concussion symptom score (PCSS)
Time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Neck Disability Index (NDI)
Time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Dizziness Handicap Inventory (DHI)
Time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Background: PubMed 15809571Broglio SP, Tomporowski PD, Ferrara MS. Balance performance with a cognitive task: a dual-task testing paradigm. Med Sci Sports Exerc. 2005 Apr;37(4):689-95. doi: 10.1249/01.mss.0000159019.14919.09.
- Background: PubMed 24284947Chang JO, Levy SS, Seay SW, Goble DJ. An alternative to the balance error scoring system: using a low-cost balance board to improve the validity/reliability of sports-related concussion balance testing. Clin J Sport Med. 2014 May;24(3):256-62. doi: 10.1097/JSM.0000000000000016.
- Background: PubMed 22900490Ciuffreda KJ, Yadav NK, Ludlam DP. Effect of binasal occlusion (BNO) on the visual-evoked potential (VEP) in mild traumatic brain injury (mTBI). Brain Inj. 2013;27(1):41-7. doi: 10.3109/02699052.2012.700088. Epub 2012 Aug 17.
- Background: PubMed 28792441Ciuffreda KJ, Yadav NK, Ludlam DP. Binasal Occlusion (BNO), Visual Motion Sensitivity (VMS), and the Visually-Evoked Potential (VEP) in mild Traumatic Brain Injury and Traumatic Brain Injury (mTBI/TBI). Brain Sci. 2017 Aug 9;7(8):98. doi: 10.3390/brainsci7080098.
- Background: PubMed 27936960Degani AM, Santos MM, Leonard CT, Rau TF, Patel SA, Mohapatra S, Danna-Dos-Santos A. The effects of mild traumatic brain injury on postural control. Brain Inj. 2017;31(1):49-56. doi: 10.1080/02699052.2016.1225982. Epub 2016 Dec 12.
- Background: PubMed 30202552Galetta KM, Liu M, Leong DF, Ventura RE, Galetta SL, Balcer LJ. The King-Devick test of rapid number naming for concussion detection: meta-analysis and systematic review of the literature. Concussion. 2015 Sep 10;1(2):CNC8. doi: 10.2217/cnc.15.8. eCollection 2016 Mar.
- Background: PubMed 25742059Galetta KM, Morganroth J, Moehringer N, Mueller B, Hasanaj L, Webb N, Civitano C, Cardone DA, Silverio A, Galetta SL, Balcer LJ. Adding Vision to Concussion Testing: A Prospective Study of Sideline Testing in Youth and Collegiate Athletes. J Neuroophthalmol. 2015 Sep;35(3):235-41. doi: 10.1097/WNO.0000000000000226.
- BackgroundGallop S. A variation on the use of binasal occlusion glasses - a case study. Journal of Behavioural Optometry 9(2): 31-35, 1998.
- BackgroundGallop S. Viewpoint 4 Binasal Occlusion - Immediate , Sustainable Symptomatic Relief. Optometry & Visual Performance 9(2):31-35, 2014.
- Background: PubMed 27104048Goble DJ, Manyak KA, Abdenour TE, Rauh MJ, Baweja HS. AN INITIAL EVALUATION OF THE BTRACKS BALANCE PLATE AND SPORTS BALANCE SOFTWARE FOR CONCUSSION DIAGNOSIS. Int J Sports Phys Ther. 2016 Apr;11(2):149-55.
- Background: PubMed 2317323Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
- Background: PubMed 26291632Hunt AW, Mah K, Reed N, Engel L, Keightley M. Oculomotor-Based Vision Assessment in Mild Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2016 Jul-Aug;31(4):252-61. doi: 10.1097/HTR.0000000000000174.
- Tobii ProLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Heidi Sveistrup, PhD principal investigator
University of Ottawa
Questions about this trial
What is this clinical trial studying?
A study testing Binasal occlusion and No binasal occlusion in people with Concussion Post Syndrome, run by University of Ottawa.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacquie J van Ierssel, PT, MSc (613-562-5800 ext. 7099, jminn044@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural sway (time frame: After one month post-injury. Data collection will occur in one single session per participant upon enrolment in the study.). 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 NCT03355339, which also lists 31 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 31 Oct 2018.