search
Back to results

Neurobiomarker for Prism Adaptation Treatment Response

Primary Purpose

Perceptual Disorders, Stroke, Biomarker

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prism Adaptation Therapy
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perceptual Disorders focused on measuring stroke, Prism Adaptation Therapy, spatial neglect

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) within 1 month of right hemisphere stroke

    2) suspected of having unilateral spatial neglect

    3) able to provide consent

    4) likely to remain in rehabilitation for 10-12 days or willing to return to the University to complete 10 sessions of treatment and post-treatment testing

    5) able to have an MRI

    6) will be or has been admitted to the Craig H. Neilson Rehabilitation Hospital for rehabilitation or is able to come to the Craig H. Neilson Rehabilitation Hospital for prism adaptation therapy sessions.

    7) age 18-90 years

    8) able to sit in a wheelchair or other chair for 1 hour

    9) able to point straight ahead and hold a pen with right hand

Exclusion Criteria:

  • 1) other neurologic, medical that would interfere with ability to complete the testing or training

    2) no uncorrected visual or hearing problems, other than hemianopsia

    3) contraindications to MRI

    4) unable to provide consent due to significant aphasia or cognitive impairment

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prism Adaptation Therapy

Arm Description

10 sessions (60 trials each) 1x/day of Prism Adaptation Therapy

Outcomes

Primary Outcome Measures

Catherine Bergego Scale
asks the impact of neglect behavior on 20 everyday tasks using a 0-3 rating scale. Higher scores = more neglect impact. Total score is sum of item scores
Catherine Bergego Scale
asks the impact of neglect behavior on 20 everyday tasks using a 0-3 rating scale. Higher scores = more neglect impact. Total score is sum of item scores

Secondary Outcome Measures

Behavioral Attention Test conventional subtests
traditional neuropsychological subtests (line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing). Total score is the sum of scores on subtests with highest score being 146. A score of 129 or higher indicates neglect
Behavioral Attention Test conventional subtests
traditional neuropsychological subtests (line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing). Total score is the sum of scores on subtests with highest score being 146. A score of 129 or higher indicates neglect

Full Information

First Posted
June 30, 2021
Last Updated
September 22, 2023
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT04966000
Brief Title
Neurobiomarker for Prism Adaptation Treatment Response
Official Title
Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
March 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

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
Preliminary data will be collected about which individuals with spatial neglect from right hemisphere stroke (aiming vs perceptual neglect) improve with Prism Adaptation Training and if there is a particular pattern of damage in the brain that predicts both the type of neglect experienced and whether neglect is improved following Prism Adaptation Training
Detailed Description
For preliminary data, twelve individuals with right hemisphere stroke and spatial neglect will participate. After pretesting for type of neglect and its severity, they will have an MRI with Diffusion Tensor Imaging (DTI). Then they will complete 10 sessions of Prism Adaptation Therapy and complete neglect post-testing. Response to Prism Adaptation Therapy will be assessed by comparing neglect scores pre- and post-training. Traditional lesion mapping, structural and functional lesion disconnectivity analyses, and tract-based spatial statistics of DTI measures will be used to examine whether any patterns of damage/dysfunction are related to a diagnosis of aiming neglect and response to Prism Adaptation Therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perceptual Disorders, Stroke, Biomarker
Keywords
stroke, Prism Adaptation Therapy, spatial neglect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a single group pre-post pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prism Adaptation Therapy
Arm Type
Experimental
Arm Description
10 sessions (60 trials each) 1x/day of Prism Adaptation Therapy
Intervention Type
Behavioral
Intervention Name(s)
Prism Adaptation Therapy
Other Intervention Name(s)
PAT
Intervention Description
Participants wear goggles with built-in prisms (a 20-diopter lens) that shift the visual scene to the right. While wearing the googles they reach to and cross out 60 lines/circles, requiring them to learn to reach more leftward than the visual targets appear. Participants can only see the end of their movements.
Primary Outcome Measure Information:
Title
Catherine Bergego Scale
Description
asks the impact of neglect behavior on 20 everyday tasks using a 0-3 rating scale. Higher scores = more neglect impact. Total score is sum of item scores
Time Frame
baseline before prism adaptation therapy
Title
Catherine Bergego Scale
Description
asks the impact of neglect behavior on 20 everyday tasks using a 0-3 rating scale. Higher scores = more neglect impact. Total score is sum of item scores
Time Frame
post-intervention immediately after prism adaptation therapy
Secondary Outcome Measure Information:
Title
Behavioral Attention Test conventional subtests
Description
traditional neuropsychological subtests (line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing). Total score is the sum of scores on subtests with highest score being 146. A score of 129 or higher indicates neglect
Time Frame
baseline pre-prism adaptation therapy
Title
Behavioral Attention Test conventional subtests
Description
traditional neuropsychological subtests (line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing). Total score is the sum of scores on subtests with highest score being 146. A score of 129 or higher indicates neglect
Time Frame
post-intervention immediately after prism adaptation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) within 1 month of right hemisphere stroke 2) suspected of having unilateral spatial neglect 3) able to provide consent 4) likely to remain in rehabilitation for 10-12 days or willing to return to the University to complete 10 sessions of treatment and post-treatment testing 5) able to have an MRI 6) will be or has been admitted to the Craig H. Neilson Rehabilitation Hospital for rehabilitation or is able to come to the Craig H. Neilson Rehabilitation Hospital for prism adaptation therapy sessions. 7) age 18-90 years 8) able to sit in a wheelchair or other chair for 1 hour 9) able to point straight ahead and hold a pen with right hand Exclusion Criteria: 1) other neurologic, medical that would interfere with ability to complete the testing or training 2) no uncorrected visual or hearing problems, other than hemianopsia 3) contraindications to MRI 4) unable to provide consent due to significant aphasia or cognitive impairment
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorie G Richards
Phone
801-585-1069
Email
lorie.richards@hsc.utah.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We may share data with colleagues at Emory University and Washington University as they are engaged in similar research and combining data may allow for greater statistical power.
Citations:
PubMed Identifier
24376064
Citation
Goedert KM, Chen P, Boston RC, Foundas AL, Barrett AM. Presence of Motor-Intentional Aiming Deficit Predicts Functional Improvement of Spatial Neglect With Prism Adaptation. Neurorehabil Neural Repair. 2014 Jun;28(5):483-93. doi: 10.1177/1545968313516872. Epub 2013 Dec 27.
Results Reference
result
PubMed Identifier
29558241
Citation
Goedert KM, Chen P, Foundas AL, Barrett AM. Frontal lesions predict response to prism adaptation treatment in spatial neglect: A randomised controlled study. Neuropsychol Rehabil. 2020 Jan;30(1):32-53. doi: 10.1080/09602011.2018.1448287. Epub 2018 Mar 20.
Results Reference
result

Learn more about this trial

Neurobiomarker for Prism Adaptation Treatment Response

We'll reach out to this number within 24 hrs