OKS for the Treatment of Hemispatial Neglect

Neglect, Hemispatial Clinical Trial

Official title:

Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03451708
• Other study ID #: 2016P000396
• Secondary ID: R21EY027468
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by Behavioral Inattention Test or Center of Cancellation Test

Exclusion Criteria:

• Reduced vision

• Documented vestibular disorder

Related Conditions & MeSH terms

• Neglect, Hemisensory
• Neglect, Hemispatial
• Neglect, Sensory
• Perceptual Disorders

Intervention

Device:
• OKS
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Johns Hopkins University, National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemispatial neglect scores	Performance on Center of Cancellation Test	After 1 hour of OKS
Primary	Change in Hemispatial neglect scores	Performance on Behavioral Inattention Test	After 1 hour of OKS
Primary	Effect of OKS on vision	visual acuity	After 1 hour of OKS
Primary	Effect of OKS on vision	reading speed	After 1 hour of OKS
Secondary	Changes in secondary hemispatial neglect scores	Line bisection score	After 1 hour of OKS
Secondary	Changes in secondary hemispatial neglect scores	grip strength	After 1 hour of OKS
Secondary	Changes in secondary hemispatial neglect scores	extinction score	After 1 hour of OKS
Secondary	Effect of OKS on gait	Gait assessment	After 1 hour of OKS
Secondary	Effect of OKS on gait	Balance assessments	After 1 hour of OKS