Oculomotor Rehabilitation After Concussion in Adults: A Feasibility Study

NCT07709936 | Completed

• 1 other identifier: 23-5303
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

After concussion, many individuals experience vision-related symptoms such as blurred vision, difficulty reading, and discomfort in visually stimulating environments, which can interfere with return to work, school, and daily activities. Oculomotor rehabilitation (OMR) is used by some clinicians to address these symptoms, but there is limited high-quality evidence to support its use. Prior to conducting a fully powered randomized controlled trial, it is necessary to determine whether such a study is feasible. This study aims to evaluate the feasibility of conducting a randomized trial comparing a six-week OMR program to usual care in adults with concussion. Adults aged 18 to 42 years who sustained a concussion 30 days to 12 months prior and report symptoms suggestive of oculomotor impairment will be recruited from an outpatient concussion clinic at the University Health Network and the community in Toronto, Ontario. Participants will be randomized to either a six-week OMR program consisting of weekly 60-minute clinic visits using head-mounted eye-tracking technology with prescribed home exercises, or usual care consisting of education and symptom management strategies. Feasibility outcomes will include recruitment rate, retention, perceived benefit of the OMR intervention, and safety (adverse events). Outcomes will be assessed at baseline and after six weeks. The findings will inform the design and implementation of a future trial evaluating the effectiveness of oculomotor rehabilitation after concussion.

Conditions

Concussion

Keywords

Concussion; Virtual reality; Brain injury; Vision; Oculomotor; Adult

Outcome Measures

Primary Outcomes (4)

• Feasibility of Recruitment

  Defined as the ability to recruit at least 32 individuals over a 12 month period.

  12 months

• Perceived Benefit of the Intervention by Participants Allocated to OMR.

  Perceived benefit of OMR in contributing to improvement in symptoms of concussion of at least 85% as measured on a scale of 0-4 (0 no benefit to 4 significant benefit) as reported after participating in 6 weekly sessions of OMR. Measured at final testing for participants in the OMR group.

  Measured at final testing (8 weeks post enrollement).

• Completion Rate of at Least 85%

  The percentage of participants completing all study requirements including: Baseline data collection, the assigned intervention, and final testing. The assigned intervention as described in the intervention section.

  At study completion (approximately 8 weeks per participant).

• Harms or Adverse Events

  No harms or adverse events (undesirable or unintended medical occurrence experienced by a study participant, regardless of whether it is directly caused by the intervention) reported by any participant from baseline through final testing, including during and immediately after intervention.

  From enrolment to final testing at 8 weeks post enrolment.

Secondary Outcomes (9)

• Randomization Rate

  Over the 12-month recruitment period.

• Compliance to Allocated Treatment Arm

  Over 6 week intervention period, measured at final testing 8 weeks post enrollment.

• Magnitude of Co-intervention

  Throughout the 6-week intervention period.

• Tolerance to VR-based Assessment and Training

  Immediately after each weekly OMR intervention session; (for 6 weeks).

• Homework Participation

  Measured weekly over the 6-week intervention period.

Study Arms (2)

Virtual reality based oculomotor intervention

EXPERIMENTAL

Participants receive 6 sessions of OMR delivered in virtual reality. Each session consists of oculomotor based trainings that increase in difficulty and duration each session. The intervention will be delivered over 6 weeks.

Other: Oculomotor exercises delivered in virtual reality

Usual Care

OTHER

Education on visual symptom management.

Other: Usual Care

Interventions

Usual Care OTHER

The UC group is education only and consists of education on visual symptom-limiting strategies and resources. These include strategies such as pacing and taking breaks during visual work, strategies to modify a visual stimulus such as increasing font size on a mobile application or changing to dark mode. An active or 'sham' is not provided.

Usual Care

Oculomotor exercises delivered in virtual reality OTHER

Participants engage in eye movement training based on the following movements: * Saccade: The ability of the eyes to shift the center of gaze quickly and accurately between targets, for example in reading * Anti-saccade: An eye movement that is made in the opposite direction of a visual stimulus * Smooth pursuit: A slow tracking eye movement, designed to keep a moving stimulus on the retina * Pursuit head free: A complex, coordinated movement where both the eyes and the head move to follow a single, slow-moving object * Optokinetic reflex: Involuntary eye movements that are triggered when watching an object moving through a visual field. It combines smooth pursuit in one direction, and a quick saccade back * Vergence: Disjunctive movements of the eyes (convergence or divergence) that align the fovea of each eye with targets located at different distances from the observer. Between study visits, participants compete home based exercises on a smart phone or tablet.

Virtual reality based oculomotor intervention

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (18 to 42 years of age) with a diagnosis of a concussion by a medical doctor between 30 days and 12 months prior
• Endorsed oculomotor related symptoms indicated by rating "moderate" or "severe" blurred-vision, double vision and/or light sensitivity.
• Normal stereopsis (depth perception) as measured with the Stereo Fly Test
• Equal (within one line difference) visual acuity between eyes as measured with the Snellen Eye Chart (Snellen, 1892) (corrected, as applicable)
• Intact extraocular movements and visual fields
• Pupils equal, round, and reactive to light and accommodation
• Healthy fundoscopic findings
• Ability to read and communicate in English

You may not qualify if:

• Diagnosed eye disease (i.e. glaucoma)
• Visual acuity less than 20/80 measured using the Snellen Eye Chart
• Severe neurocognitive deficits expected to interfere with participation
• Residence more than 100 km from the study site

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator
• Mitacs: collaborator

Study Sites (1)

KITE University Health Network

Toronto, Ontario, M5G 2A2, Canada

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Tatyana Mollayeva, MD, PhD

  KITE University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: July 17, 2026
• Study Start: May 6, 2024
• Primary Completion: July 12, 2025
• Study Completion: September 1, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months following publication of the primary study.
• Access Criteria: De-identified individual participant data underlying results reported in peer-reviewed publications will be made available upon reasonable request to the principal investigator. Requests for data access will be evaluated on a case-by-case basis. Data sharing will be approved where the proposed use has been reviewed and approved by an independent ethics review committee and the trial sponsor.

Locations

CA (1)