Brain ConcussionVisComNCT05862571
Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
An observational study of Brain Concussion and mTBI - Mild Traumatic Brain Injury, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion, mTBI - Mild Traumatic Brain Injury
- How many people
- 197 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2022to 31 Oct 2024
- How long will I take part?
- 60 Days
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects (N=200) will be recruited through 5 optometric clinics on Zealand, DK. The objective is to recruit 100 individuals with mTBI and 100 individuals without mTBI (control group). The control group will consist of relatives of the individuals with mTBI, preferably a partner or a sibling.
Who may be able to join
- Individuals may be included if they:
- are adults between the ages 18 and 67
- have been diagnosed with mTBI by a doctor (emergency room or general practice) either exclusively or with another diagnosis e.g. fracture, neck trauma (doesn't apply to control group)
- can read and understand Danish
- continuously have symptoms related to trauma ≥ 2 months and ≤ 24 months after trauma origin (doesn't apply to control group)
- have best corrected visus at 0.8 or better in both eyes at distance
- have given informed consent and willingness to participate in the study
Who cannot join
- The following will be excluded if individuals:
- are diagnosed with one of the following neurological disorders: severe head trauma, brain tumor, Parkinson's disease, multiple sclerosis, dementia
- are diagnosed with a current active psychiatric disorder
- are diagnosed with one of the following somatic disorders which are unregulated: diabetes mellitus, metabolic disorders
- have a verified alcohol or drug abuse
- have amblyopia (that is, two lines difference or more in best corrected visus between the two eyes)
- have other visual problems such as constant strabismus, a history of strabismus surgery, congenital nystagmus and recognized eye illnesses such as glaucoma, age-related macular degeneration (AMD)
- have received vision therapy by an optometrist in relation to resent mTBI
Trial locations and contacts
1 site in 1 country.
About this study
Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Furthermore, it is unknown whether optometric measurements currently used in assessing vision problems are consistent with patients' subjective complaints experienced in everyday life. A better understanding of patients' visual challenges combined with objective measurements, will contribute to a better and more efficient diagnostic investigation and treatment.
The aim of this study is to get a better understanding of patients who are suffering from visual dysfunction after mTBI. This understanding will be gained by:
Read more
- developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI.
- developing eye tracking based screening tools applicable both in- and outside of optometry clinics
- examining relationships between self-reported data, eye tracking measurements and optometric measurements.
The study will consist of N = 200 subjects. N = 100 of the subjects are suffering from mTBI (commotio group). The second group N = 100 is the non-injured group that preferably will consist of relatives to the subjects in the commotio group. The subjects in both groups have to answer the questionnaires regarding subjective visual complains, undergo optometric tests and undergo eye tracking measurements.
- Keywords
- mTBI, Ocular Motility Disorders, Oculomotor Disorder, Mild Traumatic Brain Injury, Concussion, Mild Concussion, Eye tracking, Questionnaire
- Medical subject headings
- Brain Concussion, Ocular Motility Disorders
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 |
|---|---|---|
| Mild traumatic brain injury group | Consist of patients who have been diagnosed with mTBI by a doctor at an emergency room or in general practice. The patients must still have symptoms related to their trauma ≥ 2 months and ≤ 24 months after trauma origin. They must not have received any vision therapy from an optometrist in relation to resent mTBI. | |
| Non-injured group | The control group will primarily consist of relatives of the individuals with mTBI, preferably a partner or a sibling. The subjects in the control group have to meet the same inclusion and exclusion criteria as the mTBI group, except that they must not be diagnosed with mild traumatic brain injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VisCom Questionnaire
Development and validation of the VisCom questionnaire consisting of 42 items and establishing a cut-off score, with the aim of uncovering subjective visual symptoms after mTBI. The patients can score their visual symptoms on a Likert scale from 1-5, where one is "never" and five is "always". The higher score the more severe symptoms. The patient symptom score will be compared to the control group symptom score.
Measured: Estimated duration: 20 minutes
Secondary outcomes (12)
The Rivermead Post Concussion Symptoms Questionnaire (RPQ)
Valid questionnaire consisting 16 items, assessing symptoms after mTBI. The patients can score their visual symptoms from 1-5, one is "not experienced at all" and five is "a severe problem". The higher score, the more server symptoms.
Measured: Estimated duration in total: 5 minutes
Vergence facility
A test of the eyes ability to converge and diverge using a 12 pd base out and 3 pd base in vergence flipper. The result is measured in cycles per minute, using a vertical line of letters 0,4/0,6 ≤ 35 years, and 0,4/1,0 >35 years.
Measured: Estimated duration in total: 2 minutes
Fusional vergence at near
A test of the eyes ability to maintain fusion at 0,4 meter using rotary prism, both positive and negative fusional vergence. The result is measured in prism diopters using a vertical line of letters 0,4/0,6.
Measured: Estimated duration in total: 2 minutes
Monocular amplitude of accommodation
A test of the eyes ability to accommodate using the Accommodation and Near Point Rule. The result is measured in cm using a vertical line with letters 0,4/0,6 with patients ≤ 35 years. The test is done separately with right and left eye.
Measured: Estimated duration in total: 2 minutes
Monocular accommodation facility
A test of the eyes ability to accommodate and relax using a using a ± 2.00 accommodative flipper. The result is measured in cycles per minute, using a vertical line of letters 0,4/0,6 patients ≤ 35 years.
Measured: Estimated duration in total: 2 minutes
Horizontal and vertical phoria
A test of the eyes natural alignment or misalignment using Modified Thorington Test measured in prism diopters at 6 meter and 0,4 meter.
Measured: Estimated duration in total: 2 minutes
Near point of convergence
A test of the eyes ability to converge using the Accommodation and Near Point Rule. The result is measured in cm using a vertical line with letters 0,4/0,6 ≤ 35 years, and 0,4/1,0 >35 years. The test is repeated twice in the optometry clinic and twice using an eye-tracking setup.
Measured: Estimated duration in total: 5 minutes
Saccadic eye movement
A test of the of saccades using 3 test cards and one demonstration card, in the optometry clinic and also using an eye-tracking setup. The result is measured in seconds and errors in total.
Measured: Estimated duration in total: 10 minutes
Reaction test
An eye-tracking test of the participant's reaction time for a visual target appearing after a random delay. The result is measured as delay from the target appears to the following reactions: eye movement initiation, target fixation. Additionally, the accuracy of the initial fixation is measured. The test is repeated 24 times with delays drawn from three normal distributions. The delays are identical between participants.
Measured: Estimated duration in total: 5 minutes
Pattern test
An eye-tracking test of the participant's ability to follow a moving circular target placed in a grid of identical moving targets. The target's position and direction of movement is indicated before the test is started. The result is measured as average fixation accuracy over the test period. The test is repeated 24 times with varying movement speed, direction, and target size.
Measured: Estimated duration in total: 5 minutes
Saccade test
An eye-tracking of the participant's ability to quickly move their eyes between two targets in a given timeframe. The targets are circular and vary in size and position for each test repetition. The result is measured in number of correct saccades between the targets as well as the average fixation error (fixation distance outside target).
Measured: Estimated duration in total: 5 minutes
Smooth pursuit test
An eye-tracking of the participant's ability to follow a small circular target's movements across a screen at various speeds and movement patterns. The test is repeated a total of 25 times comprised of 5 movement speeds for each of 5 patterns (horizontal line, vertical line, two diagonal lines, circle). The result is measured as average target deviation, number and duration of blinks, and number and amplitude of saccadic movements.
Measured: Estimated duration in total: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Dec 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 197 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IT University of Copenhagen, University of Copenhagen, Synoptik-Fonden, The Danish Victims Fund
- Responsible party
- Principal investigator, Hana Malá Rytter, Bispebjerg Hospital
- Investigators
- Hana M Rytter, PhD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862571
- Sponsor's protocol ID
- VisCom
- Acronym
- VisCom
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Instruments for Measuring Visual Symptoms in Victims of Concussion
- ClinicalTrials.gov ID
- NCT05862571
- Acronym / sponsor ID
- VisCom / VisCom
- Keywords
- mTBI, Ocular Motility Disorders, Oculomotor Disorder, Mild Traumatic Brain Injury, Concussion, Mild Concussion, Eye tracking, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- IT University of Copenhagen, University of Copenhagen, Synoptik-Fonden, The Danish Victims Fund
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 17 May 2023 (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.
Visual dysfunction after mild traumatic brain injury (mTBI) is common but often remain undiscovered during longer periods of time. No valid, reliable and easy-to-use screening instrument for uncovering visual dysfunction exists. Furthermore, it is unknown whether optometric measurements currently used in assessing vision problems are consistent with patients' subjective complaints experienced in everyday life. A better understanding of patients' visual challenges combined with objective measurements, will contribute to a better and more efficient diagnostic investigation and treatment.
The aim of this study is to get a better understanding of patients who are suffering from visual dysfunction after mTBI. This understanding will be gained by:
- developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI.
- developing eye tracking based screening tools applicable both in- and outside of optometry clinics
- examining relationships between self-reported data, eye tracking measurements and optometric measurements.
The study will consist of N = 200 subjects. N = 100 of the subjects are suffering from mTBI (commotio group). The second group N = 100 is the non-injured group that preferably will consist of relatives to the subjects in the commotio group. The subjects in both groups have to answer the questionnaires regarding subjective visual complains, undergo optometric tests and undergo eye tracking measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 60 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild traumatic brain injury group | – | –Consist of patients who have been diagnosed with mTBI by a doctor at an emergency room or in general practice. The patients must still have symptoms related to their trauma ≥ 2 months and ≤ 24 months after trauma origin. They must not have received any vision therapy from an optometrist in relation to resent mTBI. |
| Non-injured group | – | –The control group will primarily consist of relatives of the individuals with mTBI, preferably a partner or a sibling. The subjects in the control group have to meet the same inclusion and exclusion criteria as the mTBI group, except that they must not be diagnosed with mild traumatic brain injury. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects (N=200) will be recruited through 5 optometric clinics on Zealand, DK. The objective is to recruit 100 individuals with mTBI and 100 individuals without mTBI (control group). The control group will consist of relatives of the individuals with mTBI, preferably a partner or a sibling.
Key inclusion criteria (7 listed)
- are adults between the ages 18 and 67
- have been diagnosed with mTBI by a doctor (emergency room or general practice) either exclusively or with another diagnosis e.g. fracture, neck trauma (doesn't apply to control group)
- can read and understand Danish
- continuously have symptoms related to trauma ≥ 2 months and ≤ 24 months after trauma origin (doesn't apply to control group)
- have best corrected visus at 0.8 or better in both eyes at distance
Key exclusion criteria (8 listed)
- are diagnosed with one of the following neurological disorders: severe head trauma, brain tumor, Parkinson's disease, multiple sclerosis, dementia
- are diagnosed with a current active psychiatric disorder
- are diagnosed with one of the following somatic disorders which are unregulated: diabetes mellitus, metabolic disorders
- have a verified alcohol or drug abuse
- have amblyopia (that is, two lines difference or more in best corrected visus between the two eyes)
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
VisCom Questionnaire
Time frame: Estimated duration: 20 minutes
Development and validation of the VisCom questionnaire consisting of 42 items and establishing a cut-off score, with the aim of uncovering subjective visual symptoms after mTBI. The patients can score their visual symptoms on a Likert scale from 1-5, where one is "never" and five is "always". The higher score the more severe symptoms. The patient symptom score will be compared to the control group symptom score.
12 secondary outcomes
The Rivermead Post Concussion Symptoms Questionnaire (RPQ)
Time frame: Estimated duration in total: 5 minutes
Vergence facility
Time frame: Estimated duration in total: 2 minutes
Fusional vergence at near
Time frame: Estimated duration in total: 2 minutes
Monocular amplitude of accommodation
Time frame: Estimated duration in total: 2 minutes
Monocular accommodation facility
Time frame: Estimated duration in total: 2 minutes
Horizontal and vertical phoria
Time frame: Estimated duration in total: 2 minutes
Near point of convergence
Time frame: Estimated duration in total: 5 minutes
Saccadic eye movement
Time frame: Estimated duration in total: 10 minutes
Reaction test
Time frame: Estimated duration in total: 5 minutes
Pattern test
Time frame: Estimated duration in total: 5 minutes
Saccade test
Time frame: Estimated duration in total: 5 minutes
Smooth pursuit test
Time frame: Estimated duration in total: 5 minutes
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 9 Sep 2026.
- 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.
Hana M Rytter, PhD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion and mTBI - Mild Traumatic Brain Injury, run by Bispebjerg Hospital at 1 site in Denmark.
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 8 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 9 Sep 2026. 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 Denmark. 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?
VisCom Questionnaire (time frame: Estimated duration: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.