Neurobiomarker for Prism Adaptation Treatment Response

• Sponsor: University of Utah (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04966000
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 1.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Perceptual Disorders; Stroke; Biomarker	Behavioral: Prism Adaptation Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: a single group pre-post pilot studya single group pre-post pilot study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment
• Anticipated Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prism Adaptation Therapy 10 sessions (60 trials each) 1x/day of Prism Adaptation Therapy	Behavioral: Prism Adaptation Therapy; 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.; Other Names: PAT

Outcome Measures

Primary Outcome Measures

1. Catherine Bergego Scale [baseline before prism adaptation therapy]

   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

2. Catherine Bergego Scale [post-intervention immediately after prism adaptation therapy]

   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

1. Behavioral Attention Test conventional subtests [baseline pre-prism adaptation therapy]

   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

2. Behavioral Attention Test conventional subtests [post-intervention immediately after prism adaptation therapy]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. within 1 month of right hemisphere stroke

1. suspected of having unilateral spatial neglect

2. able to provide consent

3. 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

4. able to have an MRI

5. 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.

6. age 18-90 years

7. able to sit in a wheelchair or other chair for 1 hour

8. 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

1. no uncorrected visual or hearing problems, other than hemianopsia

2. contraindications to MRI

3. unable to provide consent due to significant aphasia or cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lorie Richards, Chair and Associate Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT04966000
• Other Study ID Numbers: IRB_00140741
• First Posted: Jul 16, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lorie Richards, Chair and Associate Professor, University of Utah: stroke; Prism Adaptation Therapy; spatial neglect
• Additional relevant MeSH terms: Perceptual Disorders

Study Results

No Results Posted as of May 17, 2022