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Prism Adaptation Therapy for Spatial Neglect

Primary Purpose

Spatial Neglect, Deficits in Attention Motor Control and Perception

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prism Adaptation Treatment
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spatial Neglect focused on measuring stroke, CVA, cerebrovascular accident, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject is 18 to 100 years of age, inclusive.
  • The subject has had a stroke on the right side of the brain.
  • The subject is able to give Informed consent.
  • The subject has a spatial neglect (if known).
  • The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.

Exclusion Criteria:

  • The subject has or had a serious brain condition other than stroke.

Sites / Locations

  • Kessler Institute for Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prism Adaptation Treatment

Control: Standard Rehabilitation Care

Arm Description

Two weeks of prism adaptation treatment followed by 4 weekly assessments and long-term follow-ups at the 3rd and 6th months.

Participants will continue with their standard inpatient rehabilitation care. They will be assessed with cognitive and functional scales for tracking their recovery.

Outcomes

Primary Outcome Measures

Kessler Foundation Neglect Assessment Process
a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)

Secondary Outcome Measures

Behavior Inattention Test
Conventional subtest, a set of paper and pencil test for spatial neglect
Barthel Index
A functional independence assessment of daily tasks

Full Information

First Posted
October 2, 2009
Last Updated
February 16, 2021
Sponsor
Kessler Foundation
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00989430
Brief Title
Prism Adaptation Therapy for Spatial Neglect
Official Title
Prism Adaptation Therapy for Spatial Neglect: Theoretical and Practical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke. This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.
Detailed Description
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke. This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect, Deficits in Attention Motor Control and Perception
Keywords
stroke, CVA, cerebrovascular accident, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prism Adaptation Treatment
Arm Type
Experimental
Arm Description
Two weeks of prism adaptation treatment followed by 4 weekly assessments and long-term follow-ups at the 3rd and 6th months.
Arm Title
Control: Standard Rehabilitation Care
Arm Type
No Intervention
Arm Description
Participants will continue with their standard inpatient rehabilitation care. They will be assessed with cognitive and functional scales for tracking their recovery.
Intervention Type
Behavioral
Intervention Name(s)
Prism Adaptation Treatment
Intervention Description
Wearing prism goggles and performing visuomotor tasks during therapy sessions.
Primary Outcome Measure Information:
Title
Kessler Foundation Neglect Assessment Process
Description
a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Behavior Inattention Test
Description
Conventional subtest, a set of paper and pencil test for spatial neglect
Time Frame
2 weeks
Title
Barthel Index
Description
A functional independence assessment of daily tasks
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is 18 to 100 years of age, inclusive. The subject has had a stroke on the right side of the brain. The subject is able to give Informed consent. The subject has a spatial neglect (if known). The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits. Exclusion Criteria: The subject has or had a serious brain condition other than stroke.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. M. Barrett, MD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

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
PubMed Identifier
31999167
Citation
Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30.
Results Reference
derived
PubMed Identifier
28167411
Citation
Caulfield MD, Chen P, Barry MM, Barrett AM. Which perseverative behaviors are symptoms of spatial neglect? Brain Cogn. 2017 Apr;113:93-101. doi: 10.1016/j.bandc.2016.11.002. Epub 2017 Feb 3.
Results Reference
derived
Links:
URL
https://kesslerfoundation.org/researchcenter/stroke/index.php
Description
Kessler Foundation Stroke Program

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Prism Adaptation Therapy for Spatial Neglect

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