Perceptual DisordersNCT04966000
Neurobiomarker for Prism Adaptation Treatment Response
A study testing Prism Adaptation Therapy in people with Perceptual Disorders and Stroke, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Perceptual Disorders, Stroke, Biomarker
- What is being tested?
- Prism Adaptation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment
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
Read the 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.
- Conditions
- Perceptual Disorders, Stroke, Biomarker
- Being tested
- Prism Adaptation Therapy
- Keywords
- stroke, Prism Adaptation Therapy, spatial neglect
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism Adaptation TherapyBehavioural
Also called PAT
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.
| Study group | Role | What they receive |
|---|---|---|
| Prism Adaptation Therapy | Experimental | 10 sessions (60 trials each) 1x/day of Prism Adaptation Therapy Receives: Behavioral: Prism Adaptation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: post-intervention immediately after prism adaptation therapy
Secondary outcomes (2)
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
Measured: baseline pre-prism adaptation therapy
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
Measured: post-intervention immediately after prism adaptation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Jan 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Why it stopped: no time to complete study in this format
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perceptual DisordersStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single group pre-post pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966000
- Sponsor's protocol ID
- IRB_00140741
- Status last verified
- Sep 2023
- First submitted
- 30 Jun 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We may share data with colleagues at Emory University and Washington University as they are engaged in similar research and combining data may allow for greater statistical power.
Publications
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.
PubMed 24376064Goedert 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.
PubMed 29558241
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Neuroimaging Biomarker to Identify Optimal Candidates for Prism Adaptation Treatment
- ClinicalTrials.gov ID
- NCT04966000
- Acronym / sponsor ID
- IRB_00140741
- Conditions
- Perceptual Disorders, Stroke, Biomarker
- Keywords
- stroke, Prism Adaptation Therapy, spatial neglect
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no time to complete study in this format
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single group pre-post pilot study
| Arm | Type | Receives |
|---|---|---|
| Prism Adaptation Therapy | Experimental | Behavioral: Prism Adaptation Therapy10 sessions (60 trials each) 1x/day of Prism Adaptation Therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prism Adaptation TherapyAlso: PATParticipants 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. | Behavioural | Prism Adaptation Therapy |
Primary outcome
Catherine Bergego Scale
Time frame: 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
Catherine Bergego Scale
Time frame: 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
2 secondary outcomes
Behavioral Attention Test conventional subtests
Time frame: baseline pre-prism adaptation therapy
Behavioral Attention Test conventional subtests
Time frame: post-intervention immediately after prism adaptation therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Results publication: PubMed 24376064Goedert 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.
- Results publication: PubMed 29558241Goedert 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.
- Individual participant dataSharing planned: Undecided. We may share data with colleagues at Emory University and Washington University as they are engaged in similar research and combining data may allow for greater statistical power.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prism Adaptation Therapy in people with Perceptual Disorders and Stroke, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catherine Bergego Scale (time frame: baseline before prism adaptation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.