Oculomotor Rehabilitation After Concussion in Adults: A Feasibility Study

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

Interventions

OTHER

Usual Care

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.

OTHER

Oculomotor exercises delivered in virtual reality

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.

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• Mitacs

  collaborator INDUSTRY

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Tatyana Mollayeva, MD, PhD · KITE University Health Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-06

Primary Completion

2025-07-12

Completion

2025-09-01

Countries

• Canada

Study Locations