Dosing and Deployment Trial: A Home-based Optokinetic Treatment
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
Study Completion
Last participant's last visit for all outcomes
August 1, 2028
June 11, 2026
April 1, 2026
1.6 years
April 2, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Health-ITUES
10 minutes
Stroke Assessment of Fall Risk
10 minutes
Caregiver Burden Scale
10 minutes
Other Outcomes (3)
The Oxford Cognitive Screen
15 minutes
Catherine Bergego Scale via the Kessler Foundation Neglect Assessment Process
45 minutes
Aphasia Rapid Test
3 minutes
Study Arms (2)
Treatment Group 1
ACTIVE COMPARATOR3 50-minute sessions of optokinetic stimulation over 7-9 days
Treatment Group 2
ACTIVE COMPARATOR5 50-minute sessions of optokinetic stimulation over 7-9 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- first and unilateral right brain damage stroke, confirmed by medical records,
- time post stroke \>6 months,
- moderate to severe SN, classified using the Catherine Bergego Scale (CBS) via the Kessler Foundation Neglect Assessment Process (KF-NAP),
- over age of 60 years, and
- IGD noted either on the KF-NAP or neuroimaging from medical records.
You may not qualify if:
- history of multiple strokes or neurological incidents (e.g., traumatic brain injury, seizures, or brain tumor),
- 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,
- cognitive impairment as defined by the Blind-MoCA,
- dependent in mobility- walking or wheelchair via medial chart,
- legally blind per medical chart,
- home located out of a 50-mile radius from Duke University, making it too costly for the frequent home visits, and
- no IGD present.
- a current care partner (defined as someone providing care and assistance) of a stroke survivor living with SN,
- English speaker,
- the stroke survivor they are caring for has been enrolled into the study.
- not a care partner currently,
- can't speak English,
- the stroke survivor didn't consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Hreha, EdD, OTR/L
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2026
First Posted
April 9, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
June 11, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share