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Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation

Primary Purpose

Spatial Neglect After Right Brain Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prism adaptation therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spatial Neglect After Right Brain Stroke focused on measuring spatial neglect, cognition, stroke rehabilitation

Eligibility Criteria

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

Inclusion Criteria: Has had a first right brain stroke >18 years of age 1-4 months post-diagnosis of right brain stroke Can sit up, see out of both eyes and point to objects (>20/50 vision in both eyes) Can give informed consent to participate Exclusion Criteria: Has been diagnosed with other chronic, disabling neurological disorder (e.g. multiple sclerosis, Alzheimer Disease) Has had a clinical left brain stroke or has neuroimaging evidence of prior stroke(s) including the presence of more than two lacunes with diameter greater than 15 mm. Cannot sit up to be tested and receive PAT Has <20/50 vision when viewing with both eyes

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GARecruiting
  • VA Central Western Massachusetts Healthcare System, Leeds, MARecruiting
  • Louis Stokes VA Medical Center, Cleveland, OHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Prism adaptation Therapy

No spatial neglect

Arm Description

People with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms.

People without spatial neglect symptoms will not receive an intervention for spatial neglect.

Outcomes

Primary Outcome Measures

Spatial neglect (SN) type (Aiming SN versus Where SN)
This variable is assignment to category defining spatial neglect. This is based on a data collection with computerized line bisection, which generates a profile score. Veterans whose computerized line bisection profile score indicates that they have spatial neglect that primarily affects movement, intention and action have Aiming SN; these Veterans responded best to prism adaptation therapy (PAT) in prior research. Alternately, Veterans may have a profile score consistent with Where SN, affecting perception and action.
Functional independence Measure (FIM) improvement trajectory
This outcome variable measures how well Veterans can carry out their daily life self-care activities independently on a validated measure, the Functional Independence Measure (FIM).

Secondary Outcome Measures

SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)
This variable examines the severity of spatial neglect as measured by functionally-valid assessment, the Behavioral Inattention Test-conventional subtest (BIT-c; max value 146, min value 0, lower is abnormal). Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
SN severity, as assessed by the Catherine Bergego Scale (CBS)
This variable (max value 30, min value 0, higher is abnormal) examines the severity of spatial neglect as measured by a functionally-valid assessment, the CBS. Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.

Full Information

First Posted
July 14, 2023
Last Updated
August 7, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05983185
Brief Title
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Official Title
Prism Adaptation Treatment (PAT) for Right Brain Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After a right brain stroke, >50% of Veterans experience problems with dressing, eating, self-care or steering their wheelchairs because their ability to move, orient, and respond toward the left side is limited: spatial neglect. Spatial neglect prevents them from functioning independently, and their needs in the hospital and at home are greatly increased. An effective treatment for spatial neglect is 10 days of visuomotor training while wearing optical prisms (PAT), however many clinicians [fail to diagnose spatial neglect and use this approach. In this study, the investigators will develop a brain scanning test that could objectively identify the Veterans with spatial neglect after stroke who are the best candidates to receive PAT and recover their ability to function. When the research is complete, the investigators expect that brain scans done in the hospital can guide the team to refer Veterans to PAT rehabilitation: improving daily life function] and quality of life.
Detailed Description
Project Summary/Abstract The application addresses the formidable treatment gap for cognitive rehabilitation of spatial neglect (SN), defined as asymmetric orienting, perception, and responding to left space after right brain stroke, causing functional disability. Although Veterans with SN are half as likely to return home, have one-third the community mobility, require 3x as much caregiver supervision, and have longer hospitalizations, increased fall risk and increased rehospitalization compared with similar right brain stroke survivors, a personalized approach to SN rehabilitation is not available in Veteran-specific systems of care. The investigators discovered that frontal lobe damage and "Aiming" SN both predict optimal recovery of functional independence after prism adaptation treatment (PAT). These findings argue for the development of an [objective, biomarker-based process to identify patients who should be administered PAT. The algorithm will be developed by identifying specific neurobiological features predictive of PAT treatment response. Thus, the investigators expect this research will deliver a critical missing element to rehabilitation, eliminating clinician uncertainty about SN diagnosis and appropriateness of PAT, and allowing a more personalized health care approach to SN rehabilitation. The team of researchers at three high-performing VA medical centers, distinguished in cognitive neurology analysis of brain imaging predictors, and stroke rehabilitation, from both advanced and clinical data, will develop the first biological parameter that can be used to assign SN rehabilitation. In 180 Veterans (120 with SN, 60 without), the investigators will define and validate brain imaging biomarkers that predict the presence of Aiming SN (Aim 1), a strong predictor of functional recovery after receiving PAT. The expectation that disconnection of frontal regions with subcortical and parietal regions will predict Aiming SN. The investigators will also examine the correlation between the brain imaging biomarkers predicting Aiming SN and improvements in daily life function after PAT (Aim 2).] Then, the investigators will determine if adding behavioral predictors to biomarker predictors (Aim 3) accounts for additional variance in the trajectory of functional recovery. The overall impact of the investigators' work will be to establish the utility of a validated biomarker that routinely identifies Veterans with SN after stroke who are the best candidates for PAT. Armed with a biomarker-based algorithm, the investigators can then carry out a large-scale PAT clinical trial, and personalized SN care. This care pathway could reduce reliance on specialized SN assessment, [coordinate VA and community systems providing Veteran stroke care,] and improve stroke care efficiency, to enhance outcomes and quality of life after stroke for thousands of Veterans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect After Right Brain Stroke
Keywords
spatial neglect, cognition, stroke rehabilitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigators are examining predictors of treatment response, hypothesized to relate to brain imaging biomarkers.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will not be aware of the location of the Veteran's stroke.
Allocation
Non-Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prism adaptation Therapy
Arm Type
Active Comparator
Arm Description
People with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms.
Arm Title
No spatial neglect
Arm Type
No Intervention
Arm Description
People without spatial neglect symptoms will not receive an intervention for spatial neglect.
Intervention Type
Behavioral
Intervention Name(s)
Prism adaptation therapy
Other Intervention Name(s)
Prism training, PAT
Intervention Description
The investigators' research and clinical group is the US leader in implementing this intervention for spatial neglect and have brought it to more than 50 clinical centers, hospitals, and treatment organizations.
Primary Outcome Measure Information:
Title
Spatial neglect (SN) type (Aiming SN versus Where SN)
Description
This variable is assignment to category defining spatial neglect. This is based on a data collection with computerized line bisection, which generates a profile score. Veterans whose computerized line bisection profile score indicates that they have spatial neglect that primarily affects movement, intention and action have Aiming SN; these Veterans responded best to prism adaptation therapy (PAT) in prior research. Alternately, Veterans may have a profile score consistent with Where SN, affecting perception and action.
Time Frame
baseline
Title
Functional independence Measure (FIM) improvement trajectory
Description
This outcome variable measures how well Veterans can carry out their daily life self-care activities independently on a validated measure, the Functional Independence Measure (FIM).
Time Frame
5 weeks after enrollment
Secondary Outcome Measure Information:
Title
SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)
Description
This variable examines the severity of spatial neglect as measured by functionally-valid assessment, the Behavioral Inattention Test-conventional subtest (BIT-c; max value 146, min value 0, lower is abnormal). Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
Time Frame
5 weeks after enrollment
Title
SN severity, as assessed by the Catherine Bergego Scale (CBS)
Description
This variable (max value 30, min value 0, higher is abnormal) examines the severity of spatial neglect as measured by a functionally-valid assessment, the CBS. Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
Time Frame
5 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has had a first right brain stroke >18 years of age 1-4 months post-diagnosis of right brain stroke Can sit up, see out of both eyes and point to objects (>20/50 vision in both eyes) Can give informed consent to participate Exclusion Criteria: Has been diagnosed with other chronic, disabling neurological disorder (e.g. multiple sclerosis, Alzheimer Disease) Has had a clinical left brain stroke or has neuroimaging evidence of prior stroke(s) including the presence of more than two lacunes with diameter greater than 15 mm. Cannot sit up to be tested and receive PAT Has <20/50 vision when viewing with both eyes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Shenette
Phone
(413) 463-1835
Email
lisa.shenette@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Anna M Barrett, MD
Phone
(973) 941-0074
Email
Anna.Barrett2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna M. Barrett, MD
Organizational Affiliation
VA Central Western Massachusetts Healthcare System, Leeds, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mykayla Jeter
Phone
404-321-6111
Email
mykayla.jeter@va.gov
First Name & Middle Initial & Last Name & Degree
Michael Dattilo, MD
Phone
4043216111
Ext
20660
Email
michael.datillo@va.gov
Facility Name
VA Central Western Massachusetts Healthcare System, Leeds, MA
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01053-9764
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber N Jones
Phone
413-584-4040
Ext
6528
Email
Amber.Jones8@va.gov
First Name & Middle Initial & Last Name & Degree
Kristin M Mattocks, PhD MPH
Phone
(413) 548-6777
Email
kristin.mattocks@va.gov
First Name & Middle Initial & Last Name & Degree
Anna M. Barrett, MD
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica McCabe, PT
Phone
216-791-3800
Ext
8203830
Email
jessica.mccabe@va.gov
First Name & Middle Initial & Last Name & Degree
Svetlana Pundik
Phone
2167913800
Ext
63732
Email
svetlana.pundik@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation

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