Neurobiomarker for Prism Adaptation Treatment Response

Not Applicable

Not yet recruiting

• Conditions: Perceptual Disorders; Biomarker; Stroke
• Interventions: Behavioral: Prism Adaptation Therapy

• Registration Number: NCT04966000
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Study Start: 2024-01
• Primary Completion: 2026-12-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States