Dosing and Deployment Trial: A Home-based Optokinetic Treatment

Dosing and Deployment Trial: A Home-based Optokinetic Treatment for Ipsilesional Gaze Deviation

Several interventions exist for remediation of spatial neglect, but they have mixed evidence. Optokinetic stimulation is a bottom-up intervention; in other words, it is a stimulus-driven process, with Level A (strongest) evidence, and is recommended in clinical practice guidelines such as the American Heart Association's stroke guidelines. The studies currently published all use varing doses (number of sessions a week), did not assess the impact on mobility and risk of falls, and have not been implemented in the home setting. It is imperative to understand how to successfully implement this intervention at home, and learn how it will impact mobility in order to better support a large population of individuals living with chronic spatial neglect and who face barriers to accessing care because they require caregiver support to leave the home. This will be done using both qualitative and quantitative methods.

Study Overview

• Status: Not yet recruiting
• Conditions: Spatial Neglect
• Intervention / Treatment: Behavioral: Optokinetic stimulation

Detailed Description

Stroke is a leading cause of disability among adults in the United States (US) and increases the risk of falls. One factor associated with excess fall risk after stroke is spatial neglect, which occurs in 54% of right brain damaged stroke survivors. Spatial neglect is caused by damaged neural networks critical for spatial attention. A hallmark symptom of spatial neglect is ipsilesional gaze deviation (IGD) , which is a sustained horizontal gaze preference toward the affected brain hemisphere. Since IGD is a major predictor of poor recovery-adversely affecting daily activities and functional mobility, and extending hospital stays because of falls-intervention is necessary. And because of the challenges of the traditional rehabilitation paradigm (short length of stay), there is a significant need for an intervention, accessible to individuals living at home with SN, that will improve mobility and risk of falls.

Optokinetic stimulation is a treatment shown to induce brain neural plasticity and improve spatial exploration, in turn reduce spatial neglect symptoms, including IGD, experienced in daily life. Optokinetic stimulation requires the participant to follow one step command: "follow the targets with your eyes". The target is a small dot that moves across the computer screen. The literature shows variation in implementation because users (mostly therapists) were required to create their own optokinetic stimulation, until just recently when Eyemove was developed. Eyemove is computer-based intervention developed to standardize the way optokinetic stimulation is administered, via an inexpensive, commercially available software program.

Via a randomized clinical trial, the researchers plan to focus on dose and feasibility in the home setting to answer the specific aims.

The study will randomize stroke participants who meet all inclusion and exclusion criteria into two intervention dose groups. Group 1 will complete 3-sessions of Eyemove, and Group 2 will complete 5-sessions of Eyemove, all within 7-9 days. Outcomes will be measured at baseline, before and after the treated period. Screening and pre-treatment assessments will take approximately 2 hours, and the post assessments will take approximately 1 hour. The post-treatment assessments will be conducted 14 days after the pre-treatment assessments.

In the interest of feasibility and limiting unnecessary burden on participants, the study team will then conduct semi-structured interviews pre-treatment with at least the first 8 stroke participants who are randomized into each group. The study team will interview them again post-treatment and will also interview care partners of stroke survivors at time of screening and pre-treatment assessment, to participate in semi-structured interviews and two assessments. The researchers will also plan to conduct these with the first 8 care partners from each group, which will be determined after the stroke survivor is randomized.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Hreha, EdD, OTR/L; Phone Number: 919-660-7596; Email: kimberly.hreha@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for stroke group:

1. first and unilateral right brain damage stroke, confirmed by medical records,
2. time post stroke >6 months,
3. moderate to severe SN, classified using the Catherine Bergego Scale (CBS) via the Kessler Foundation Neglect Assessment Process (KF-NAP),
4. over age of 60 years, and
5. IGD noted either on the KF-NAP or neuroimaging from medical records.

Exclusion Criteria for stroke group:

1. history of multiple strokes or neurological incidents (e.g., traumatic brain injury, seizures, or brain tumor),
2. unable to communicate through spoken English, screened using the Aphasia Rapid Test (ART), as instructions for treatment and assessment tasks will be provided verbally in English,
3. cognitive impairment as defined by the Blind-MoCA,
4. dependent in mobility- walking or wheelchair via medial chart,
5. legally blind per medical chart,
6. home located out of a 50-mile radius from Duke University, making it too costly for the frequent home visits, and
7. no IGD present.

Inclusion Criteria for caregiver group:

1. a current care partner (defined as someone providing care and assistance) of a stroke survivor living with SN,
2. English speaker,
3. the stroke survivor they are caring for has been enrolled into the study.

Exclusion Criteria for caregiver group:

1. not a care partner currently,
2. can't speak English,
3. the stroke survivor didn't consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group 1; 3 50-minute sessions of optokinetic stimulation over 7-9 days	Behavioral: Optokinetic stimulation; Visual scanning (repeated eye movements) from one side of the computer to the neglected side of space. The target is 30 to 70 dots, randomly displayed (of all colors, size: 2- 4 cm) on a dark background on a computer screen.
Active Comparator: Treatment Group 2; 5 50-minute sessions of optokinetic stimulation over 7-9 days	Behavioral: Optokinetic stimulation; Visual scanning (repeated eye movements) from one side of the computer to the neglected side of space. The target is 30 to 70 dots, randomly displayed (of all colors, size: 2- 4 cm) on a dark background on a computer screen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Mobility Assessment Course	Evaluates a person's mobility, using visual search multitask, to assess neglect, and its relation with existing neglect tasks. The change in score from pre- to post-treatment is the primary outcome measure of the study. For this assessment, the focus on side-to side spatial imbalance (the total score is the difference between targets found on the right versus the left side). There are 40 targets (20 on each side). Lower total score indicates a poorer performance (0-40). The mean control asymmetry= 0.75 (SD=0.81), and if the asymmetry score is greater or equal to 2.78, neglect is present.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-ITUES	A 20-item questionnaire that evaluates the impact, perceived usefulness, perceived ease of use about a specific technology. The change in score from pre- to post-treatment is a secondary outcome measure of the study. The score is calculated as the mean of all items with each item weighted equally. The higher the score, the more usable the person feels the technology is. Range of possible scores is 1 to 5.	10 minutes
Stroke Assessment of Fall Risk	A tool which includes items related to stroke-specific neurologic deficits to determine the ability to predict falls. The change in score from pre- to post-treatment is a secondary outcome measure of the study. If the total score has 0 yes responses- there is low fall risk. If the total score = 1 yes response, then there is a level 1 fall risk. And if the total score =2 or more yes responses, or any yes response to item 3 (nursing judgment) then this is a Level 2 fall risk (highest amount).	10 minutes
Caregiver Burden Scale	A 22-item scale to determine burden that is experienced by care partners. The change in score from pre- to post-treatment is a secondary outcome measure of the study. There are multiple categories in this scale. Items 1-8 gains insight into general strain, 9-11 captures information on isolation, and 12-16 captures information on disappointment, and 17-19 on emotional involvement, and 20-22 on environmental burden. The higher the score the more burden the caregiver has (range from 1 (not at all) to 88 (often)).	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blind-MOCA	Assesses different cognitive domains: attention and concentration, memory, language, conceptual thinking, calculations and orientation. The assessment does not require vision to complete each domain. The higher the total score, the more cognitively intact. Normal cognition is greater than or equal to 18 out of 22.	5 minutes
Catherine Bergego Scale via the Kessler Foundation Neglect Assessment Process	10 real-life items that are assessed through direct observation following the Kessler Foundation Neglect Assessment Process (KF-NAP). The 10 items are: gaze orientation (*which is IGD), limb awareness, auditory attention, personal belongings, dressing, grooming, navigation, collisions, meals, and cleaning after meals. Each item is scored from 0 (no neglect) to 3 (severe neglect). The final scores from 0-30 and indicates the overall severity of spatial neglect as one single construct.	45 minutes
Aphasia Rapid Test	Screens for communication deficits that would impact ability to follow instructions with higher score indicating more severe aphasia (0/26), 0= no aphasia and 26= the most aphasia possible.	3 minutes

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Kimberly Hreha, EdD, OTR/L, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: spatial neglect; optokinetic stimulation; stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Pro00118913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No