NCT05622344

StableEyes With Active Neurofeedback

StableEyes With Active Neurophysiological Feedback

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The investigators have developed a self-administered rehabilitation tool that incrementally guides the user to increase head motion to mitigate motion sickness and enhance postural recovery following centrifugation or unilateral vestibular nerve deafferentation surgery.

Detailed description

The rehabilitation device guides users to perform sinusoidal head rotations, matched to a metronome, about the yaw, pitch, and roll axes (60 sec epochs, 5 minutes per axis, 15 min total). The assessment for each axis consists of the number of completed epochs with each epoch requiring head rotations of a different amplitude. Subjects are instructed to begin with an 'easy' amplitude (i.e. small) and increase or decrease amplitude depending on the subject's perception of motion sickness - which is input from 0 (absent motion sick) to 11 (vomit) using a handheld controller. Video-oculography captures eye and head velocity as well as tracks the number of blinks and saccades, metrics that can indicate worsening nausea.

Conditions

• Vestibular Disorder
• Vestibular Schwannoma
• Space Motion Sickness
• Motion Sickness

Interventions

Type	Name	Description
BEHAVIORAL	Traditional Therapy	Exercises that teaches subjects to move their heads while viewing still or moving targets.
DEVICE	SWAN	The SWAN device uses video-oculography to monitor head motion while guiding participants to move their head in yaw, pitch, roll planes for 15 minutes. Feedback is provided regarding frequency and plane of head rotation

Timeline

• Start date: 2022-08-08
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2022-11-18
• Last updated: 2025-11-10

Locations

2 sites across 1 country: United States