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OKS for the Treatment of Hemispatial Neglect

Primary Purpose

Neglect, Hemispatial, Neglect, Sensory, Neglect, Hemisensory

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OKS
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neglect, Hemispatial

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Optimization of OKS

Safety and efficacy study

Effect of repetitive stimulation

OKS and gait

Arm Description

Crossover study examining various OKS protocols on improving symptoms of hemispatial neglect

Randomized study assessing the safety and efficacy of OKS in treating hemispatial neglect

Benefits of daily, repetitive OKS in treating hemispatial neglect

Effect of OKS on gait and balance

Outcomes

Primary Outcome Measures

Change in Hemispatial neglect scores
Performance on Center of Cancellation Test
Change in Hemispatial neglect scores
Performance on Behavioral Inattention Test
Effect of OKS on vision
visual acuity
Effect of OKS on vision
reading speed

Secondary Outcome Measures

Changes in secondary hemispatial neglect scores
Line bisection score
Changes in secondary hemispatial neglect scores
grip strength
Changes in secondary hemispatial neglect scores
extinction score
Effect of OKS on gait
Gait assessment
Effect of OKS on gait
Balance assessments

Full Information

First Posted
February 8, 2018
Last Updated
April 20, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Johns Hopkins University, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT03451708
Brief Title
OKS for the Treatment of Hemispatial Neglect
Official Title
Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Johns Hopkins University, National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neglect, Hemispatial, Neglect, Sensory, Neglect, Hemisensory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Patient blinded
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimization of OKS
Arm Type
Experimental
Arm Description
Crossover study examining various OKS protocols on improving symptoms of hemispatial neglect
Arm Title
Safety and efficacy study
Arm Type
Experimental
Arm Description
Randomized study assessing the safety and efficacy of OKS in treating hemispatial neglect
Arm Title
Effect of repetitive stimulation
Arm Type
Experimental
Arm Description
Benefits of daily, repetitive OKS in treating hemispatial neglect
Arm Title
OKS and gait
Arm Type
Experimental
Arm Description
Effect of OKS on gait and balance
Intervention Type
Device
Intervention Name(s)
OKS
Intervention Description
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.
Primary Outcome Measure Information:
Title
Change in Hemispatial neglect scores
Description
Performance on Center of Cancellation Test
Time Frame
After 1 hour of OKS
Title
Change in Hemispatial neglect scores
Description
Performance on Behavioral Inattention Test
Time Frame
After 1 hour of OKS
Title
Effect of OKS on vision
Description
visual acuity
Time Frame
After 1 hour of OKS
Title
Effect of OKS on vision
Description
reading speed
Time Frame
After 1 hour of OKS
Secondary Outcome Measure Information:
Title
Changes in secondary hemispatial neglect scores
Description
Line bisection score
Time Frame
After 1 hour of OKS
Title
Changes in secondary hemispatial neglect scores
Description
grip strength
Time Frame
After 1 hour of OKS
Title
Changes in secondary hemispatial neglect scores
Description
extinction score
Time Frame
After 1 hour of OKS
Title
Effect of OKS on gait
Description
Gait assessment
Time Frame
After 1 hour of OKS
Title
Effect of OKS on gait
Description
Balance assessments
Time Frame
After 1 hour of OKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Lim, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34196963
Citation
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Results Reference
derived

Learn more about this trial

OKS for the Treatment of Hemispatial Neglect

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