Neurobiomarker for Prism Adaptation Treatment Response

NCT04966000 | Withdrawn

• 1 other identifier: IRB_00140741
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Perceptual Disorders; Stroke; Biomarker

Keywords

stroke; Prism Adaptation Therapy; spatial neglect

Outcome Measures

Primary Outcomes (2)

• 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

  baseline before prism adaptation therapy

• 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

  post-intervention immediately after prism adaptation therapy

Secondary Outcomes (2)

• Behavioral Attention Test conventional subtests

  baseline pre-prism adaptation therapy

• Behavioral Attention Test conventional subtests

  post-intervention immediately after prism adaptation therapy

Study Arms (1)

Prism Adaptation Therapy

EXPERIMENTAL

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

Behavioral: Prism Adaptation Therapy

Interventions

Prism Adaptation Therapy BEHAVIORAL

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.

Also known as: PAT

Prism Adaptation Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) within 1 month of right hemisphere stroke
• \) suspected of having unilateral spatial neglect
• \) able to provide consent
• \) 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
• \) able to have an MRI
• \) 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.
• \) age 18-90 years
• \) able to sit in a wheelchair or other chair for 1 hour
• \) able to point straight ahead and hold a pen with right hand

You may not qualify if:

• \) other neurologic, medical that would interfere with ability to complete the testing or training
• \) no uncorrected visual or hearing problems, other than hemianopsia
• \) contraindications to MRI
• \) unable to provide consent due to significant aphasia or cognitive impairment

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• 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.

  PMID: 24376064 RESULT

• 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.

  PMID: 29558241 RESULT

MeSH Terms

Conditions

Perceptual Disorders; Stroke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a single group pre-post pilot study

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 16, 2021
• Study Start: January 1, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: June 17, 2025

Record last verified: 2023-09

Locations

US (1)