Screening Instruments for Measuring Visual Symptoms in Victims of Concussion

NCT05862571 | Unknown

• 1 other identifier: VISCOM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.developing and validating a questionnaire for uncovering subjective visual complaints in subjects with mTBI.
2. 2.developing eye tracking based screening tools applicable both in- and outside of optometry clinics
3. 3.examining relationships between self-reported data, eye tracking measurements and optometric measurements.

Conditions

Brain Concussion; mTBI - Mild Traumatic Brain Injury

Keywords

mTBI; Ocular Motility Disorders; Oculomotor Disorder; Mild Traumatic Brain Injury; Concussion; Mild Concussion; Eye tracking; Questionnaire

Outcome Measures

Primary Outcomes (1)

• VISCOM Questionnaire

  Development and validation of the VISCOM questionnaire consisting of 42 times 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.

  Estimated duration: 20 minutes

Secondary Outcomes (12)

• The Rivermead Post Concussion Symptoms Questionnaire (RPQ)

  Estimated duration in total: 5 minutes

• Vergence facility

  Estimated duration in total: 2 minutes

• Fusional vergence at near

  Estimated duration in total: 2 minutes

• Monocular amplitude of accommodation

  Estimated duration in total: 2 minutes

• Monocular accommodation facility

  Estimated duration in total: 2 minutes

Other Outcomes (3)

• Nystagmus test

  Estimated duration in total: 5 minutes

• Stereopsis

  Estimated duration in total: 2 minutes.

• Vectogram no.12

  Estimated duration in total: 2 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• IT University of Copenhagen: collaborator
• The Danish Victims Fund: collaborator
• Synoptik-Fonden: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Bispebjerg hospital

Copenhagen, Capital Region, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Hana M Rytter, PhD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan S Lauridsen, MA

CONTACT

45 93565023; ryan.lauridsen@cfh.ku.dk

Hana M Rytter, PhD

CONTACT

45 21651533; hana.mala@psy.ku.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Danish Concussion Center, Associate Professor at University of Copenhagen and Neuropsychologist at Bispebjerg Hospital

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 17, 2023
• Study Start: December 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)