Clinical trial NCT04966000: Neurobiomarker for Prism Adaptation Treatment Response
Official title: Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Perceptual Disorders
Stroke
Biomarker
Keywords: stroke
Prism Adaptation Therapy
spatial neglect
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single group pre-post pilot study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Catherine Bergego Scale
timeFrame: baseline before prism adaptation therapy
measure: Catherine Bergego Scale
timeFrame: post-intervention immediately after prism adaptation therapy
Secondary outcomes:
measure: Behavioral Attention Test conventional subtests
timeFrame: baseline pre-prism adaptation therapy
measure: Behavioral Attention Test conventional subtests
timeFrame: post-intervention immediately after prism adaptation therapy
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
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.
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.