Screening Instruments for Measuring Visual Symptoms in Victims of Concussion

NCT ID: NCT05862571

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-31

Brief 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. 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:

1. developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI.

2. developing eye tracking based screening tools applicable both in- and outside of optometry clinics

3. 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.

Conditions

Brain Concussion; mTBI - Mild Traumatic Brain Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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 and at near
• have given informed consent and willingness to participate in the study

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IT University of Copenhagen

OTHER

Sponsor Role: collaborator

The Danish Victims Fund

OTHER_GOV

Sponsor Role: collaborator

Synoptik-Fonden

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hana Malá Rytter

Head of the Danish Concussion Center, Associate Professor at University of Copenhagen and Neuropsychologist at Bispebjerg Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hana M Rytter, PhD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg hospital

Copenhagen, Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ryan S Lauridsen, MA

Role: CONTACT

ryan.lauridsen@cfh.ku.dk

45 93565023

Hana M Rytter, PhD

Role: CONTACT

hana.mala@psy.ku.dk

45 21651533

Facility Contacts

Ryan S Lauridsen, MA

Role: primary

ryan.lauridsen@cfh.ku.dk

+45 93565023

Hana M. Rytter, Ph.d Psych.

Role: backup

hana.mala.rytter@regionh.dk

+45 38635247

Other Identifiers

VISCOM

Identifier Type: -

Identifier Source: org_study_id