Neurobiomarker for Prism Adaptation Treatment Response

Stroke Clinical Trial

Official title:

Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04966000
• Other study ID #: IRB_00140741
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: March 30, 2027

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: March 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarker
• Perceptual Disorders
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	baseline pre-prism adaptation therapy
Secondary	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	post-intervention immediately after prism adaptation therapy