Spatial Neglect After Right Brain StrokeNCT05983185
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
A study testing Prism adaptation therapy in people with Spatial Neglect After Right Brain Stroke, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
After a right brain stroke, >50% of Veterans experience problems with dressing, eating, self-care or steering their wheelchairs because their ability to move, orient, and respond toward the left side is limited: spatial neglect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spatial Neglect After Right Brain Stroke
- 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
- 244 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has had a first right brain stroke >18 years of age
- 1-4 months post-diagnosis of right brain stroke
- Can sit up, see out of both eyes and point to objects (>20/50 vision in both eyes)
- Can give informed consent to participate
Who cannot join
- Has been diagnosed with other chronic, disabling neurological disorder (e.g. multiple sclerosis, Alzheimer Disease)
- Has had a clinical left brain stroke or has neuroimaging evidence of prior stroke(s) including the presence of more than two lacunes with diameter greater than 15 mm.
- Cannot sit up to be tested and receive PAT
- Has <20/50 vision when viewing with both eyes
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna M Barrett, MD contact
United States4 sites, 4 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Jessica McCabe, PT, 216-791-3800 ext. 8203830, jessica.mccabe@va.gov
Svetlana Pundik, 2167913800 ext. 63732, svetlana.pundik@va.gov
- Recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Mychaela Eatmon, 404-725-3256, mychaela.eatmon@va.gov
Michael Dattilo, MD, 4043216111 ext. 20660, michael.datillo@va.gov
- Recruiting
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
Emily Muller, BA, 508-254-7217, emily.muller@umassmed.edu
Anna M Barrett, MD, Anna.Barrett2@va.gov
- Recruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Sharon Bottomley, DNP, 203-932-5711, sharon.bottomley@va.gov
Nishant Mishra, MD, 6504408349, nishant.mishra@va.gov
About this study
Official title: Prism Adaptation Treatment (PAT) for Right Brain Stroke Rehabilitation
After a right brain stroke, >50% of Veterans experience problems with dressing, eating, self-care or steering their wheelchairs because their ability to move, orient, and respond toward the left side is limited: spatial neglect. Spatial neglect prevents them from functioning independently, and their needs in the hospital and at home are greatly increased. An effective treatment for spatial neglect is 10 days of visuomotor training while wearing optical prisms (PAT), however many clinicians [fail to diagnose spatial neglect and use this approach. In this study, the investigators will develop a brain scanning test that could objectively identify the Veterans with spatial neglect after stroke who are the best candidates to receive PAT and recover their ability to function. When the research is complete, the investigators expect that brain scans done in the hospital can guide the team to refer Veterans to PAT rehabilitation: improving daily life function] and quality of life.
Read the detailed description
Project Summary/Abstract The application addresses the formidable treatment gap for cognitive rehabilitation of spatial neglect (SN), defined as asymmetric orienting, perception, and responding to left space after right brain stroke, causing functional disability. Although Veterans with SN are half as likely to return home, have one-third the community mobility, require 3x as much caregiver supervision, and have longer hospitalizations, increased fall risk and increased rehospitalization compared with similar right brain stroke survivors, a personalized approach to SN rehabilitation is not available in Veteran-specific systems of care. The investigators discovered that frontal lobe damage and "Aiming" SN both predict optimal recovery of functional independence after prism adaptation treatment (PAT). These findings argue for the development of an [objective, biomarker-based process to identify patients who should be administered PAT. The algorithm will be developed by identifying specific neurobiological features predictive of PAT treatment response. Thus, the investigators expect this research will deliver a critical missing element to rehabilitation, eliminating clinician uncertainty about SN diagnosis and appropriateness of PAT, and allowing a more personalized health care approach to SN rehabilitation. The team of researchers at three high-performing VA medical centers, distinguished in cognitive neurology analysis of brain imaging predictors, and stroke rehabilitation, from both advanced and clinical data, will develop the first biological parameter that can be used to assign SN rehabilitation. In 180 Veterans (120 with SN, 60 without), the investigators will define and validate brain imaging biomarkers that predict the presence of Aiming SN (Aim 1), a strong predictor of functional recovery after receiving PAT. The expectation that disconnection of frontal regions with subcortical and parietal regions will predict Aiming SN. The investigators will also examine the correlation between the brain imaging biomarkers predicting Aiming SN and improvements in daily life function after PAT (Aim 2).] Then, the investigators will determine if adding behavioral predictors to biomarker predictors (Aim 3) accounts for additional variance in the trajectory of functional recovery. The overall impact of the investigators' work will be to establish the utility of a validated biomarker that routinely identifies Veterans with SN after stroke who are the best candidates for PAT. Armed with a biomarker-based algorithm, the investigators can then carry out a large-scale PAT clinical trial, and personalized SN care. This care pathway could reduce reliance on specialized SN assessment, [coordinate VA and community systems providing Veteran stroke care,] and improve stroke care efficiency, to enhance outcomes and quality of life after stroke for thousands of Veterans.
- Conditions
- Spatial Neglect After Right Brain Stroke
- Being tested
- Prism adaptation therapy
- Keywords
- spatial neglect, cognition, stroke rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prism adaptation therapyBehavioural
Also called Prism training, PAT
The investigators' research and clinical group is the US leader in implementing this intervention for spatial neglect and have brought it to more than 50 clinical centers, hospitals, and treatment organizations.
| Study group | Role | What they receive |
|---|---|---|
| Prism adaptation Therapy | Active comparator | People with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms. Receives: Behavioral: Prism adaptation therapy |
| No spatial neglect | No intervention | People without spatial neglect symptoms will not receive an intervention for spatial neglect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial neglect (SN) type (Aiming SN versus Where SN)
This variable is assignment to category defining spatial neglect. This is based on a data collection with computerized line bisection, which generates a profile score. Veterans whose computerized line bisection profile score indicates that they have spatial neglect that primarily affects movement, intention and action have Aiming SN; these Veterans responded best to prism adaptation therapy (PAT) in prior research. Alternately, Veterans may have a profile score consistent with Where SN, affecting perception and action.
Measured: baseline
Functional independence Measure (FIM) improvement trajectory
This outcome variable measures how well Veterans can carry out their daily life self-care activities independently on a validated measure, the Functional Independence Measure (FIM).
Measured: 5 weeks after enrollment
Secondary outcomes (2)
SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)
This variable examines the severity of spatial neglect as measured by functionally-valid assessment, the Behavioral Inattention Test-conventional subtest (BIT-c; max value 146, min value 0, lower is abnormal). Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
Measured: 5 weeks after enrollment
SN severity, as assessed by the Catherine Bergego Scale (CBS)
This variable (max value 30, min value 0, higher is abnormal) examines the severity of spatial neglect as measured by a functionally-valid assessment, the CBS. Functionally-valid spatial neglect assessments predict independence for activities of daily living, and care needs.
Measured: 5 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial Neglect After Right Brain StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The investigators are examining predictors of treatment response, hypothesized to relate to brain imaging biomarkers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anna M. Barrett, MD, Principal investigator, VA Central Western Massachusetts Healthcare System, Leeds, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983185
- Sponsor's protocol ID
- C3662-R
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prism Adaptation Treatment (PAT) for Right Brain Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05983185
- Acronym / sponsor ID
- C3662-R
- Conditions
- Spatial Neglect After Right Brain Stroke
- Keywords
- spatial neglect, cognition, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Aug 2023 (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.
After a right brain stroke, >50% of Veterans experience problems with dressing, eating, self-care or steering their wheelchairs because their ability to move, orient, and respond toward the left side is limited: spatial neglect. Spatial neglect prevents them from functioning independently, and their needs in the hospital and at home are greatly increased. An effective treatment for spatial neglect is 10 days of visuomotor training while wearing optical prisms (PAT), however many clinicians [fail to diagnose spatial neglect and use this approach. In this study, the investigators will develop a brain scanning test that could objectively identify the Veterans with spatial neglect after stroke who are the best candidates to receive PAT and recover their ability to function. When the research is complete, the investigators expect that brain scans done in the hospital can guide the team to refer Veterans to PAT rehabilitation: improving daily life function] and quality of life.
Detailed description
Project Summary/Abstract The application addresses the formidable treatment gap for cognitive rehabilitation of spatial neglect (SN), defined as asymmetric orienting, perception, and responding to left space after right brain stroke, causing functional disability. Although Veterans with SN are half as likely to return home, have one-third the community mobility, require 3x as much caregiver supervision, and have longer hospitalizations, increased fall risk and increased rehospitalization compared with similar right brain stroke survivors, a personalized approach to SN rehabilitation is not available in Veteran-specific systems of care. The investigators discovered that frontal lobe damage and "Aiming" SN both predict optimal recovery of functional independence after prism adaptation treatment (PAT). These findings argue for the development of an [objective, biomarker-based process to identify patients who should be administered PAT. The algorithm will be developed by identifying specific neurobiological features predictive of PAT treatment response. Thus, the investigators expect this research will deliver a critical missing element to rehabilitation, eliminating clinician uncertainty about SN diagnosis and appropriateness of PAT, and allowing a more personalized health care approach to SN rehabilitation. The team of researchers at three high-performing VA medical centers, distinguished in cognitive neurology analysis of brain imaging predictors, and stroke rehabilitation, from both advanced and clinical data, will develop the first biological parameter that can be used to assign SN rehabilitation. In 180 Veterans (120 with SN, 60 without), the investigators will define and validate brain imaging biomarkers that predict the presence of Aiming SN (Aim 1), a strong predictor of functional recovery after receiving PAT. The expectation that disconnection of frontal regions with subcortical and parietal regions will predict Aiming SN. The investigators will also examine the correlation between the brain imaging biomarkers predicting Aiming SN and improvements in daily life function after PAT (Aim 2).] Then, the investigators will determine if adding behavioral predictors to biomarker predictors (Aim 3) accounts for additional variance in the trajectory of functional recovery. The overall impact of the investigators' work will be to establish the utility of a validated biomarker that routinely identifies Veterans with SN after stroke who are the best candidates for PAT. Armed with a biomarker-based algorithm, the investigators can then carry out a large-scale PAT clinical trial, and personalized SN care. This care pathway could reduce reliance on specialized SN assessment, [coordinate VA and community systems providing Veteran stroke care,] and improve stroke care efficiency, to enhance outcomes and quality of life after stroke for thousands of Veterans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators are examining predictors of treatment response, hypothesized to relate to brain imaging biomarkers.
| Arm | Type | Receives |
|---|---|---|
| Prism adaptation Therapy | Active comparator | Behavioral: Prism adaptation therapyPeople with spatial neglect will receive this effective treatment to reduce symptoms, which the investigators' previous work indicated may be particularly effective for Aiming SN symptoms. |
| No spatial neglect | No intervention | –People without spatial neglect symptoms will not receive an intervention for spatial neglect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has had a first right brain stroke >18 years of age
- 1-4 months post-diagnosis of right brain stroke
- Can sit up, see out of both eyes and point to objects (>20/50 vision in both eyes)
- Can give informed consent to participate
Key exclusion criteria (4 listed)
- Has been diagnosed with other chronic, disabling neurological disorder (e.g. multiple sclerosis, Alzheimer Disease)
- Has had a clinical left brain stroke or has neuroimaging evidence of prior stroke(s) including the presence of more than two lacunes with diameter greater than 15 mm.
- Cannot sit up to be tested and receive PAT
- Has <20/50 vision when viewing with both eyes
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: Prism training, PATThe investigators' research and clinical group is the US leader in implementing this intervention for spatial neglect and have brought it to more than 50 clinical centers, hospitals, and treatment organizations. | Behavioural | Prism adaptation Therapy |
Primary outcome
Spatial neglect (SN) type (Aiming SN versus Where SN)
Time frame: baseline
This variable is assignment to category defining spatial neglect. This is based on a data collection with computerized line bisection, which generates a profile score. Veterans whose computerized line bisection profile score indicates that they have spatial neglect that primarily affects movement, intention and action have Aiming SN; these Veterans responded best to prism adaptation therapy (PAT) in prior research. Alternately, Veterans may have a profile score consistent with Where SN, affecting perception and action.
Functional independence Measure (FIM) improvement trajectory
Time frame: 5 weeks after enrollment
This outcome variable measures how well Veterans can carry out their daily life self-care activities independently on a validated measure, the Functional Independence Measure (FIM).
2 secondary outcomes
SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)
Time frame: 5 weeks after enrollment
SN severity, as assessed by the Catherine Bergego Scale (CBS)
Time frame: 5 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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.
Anna M Barrett, MD contact
Anna M. Barrett, MD principal investigator
VA Central Western Massachusetts Healthcare System, Leeds, MA
4 sites 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 Spatial Neglect After Right Brain Stroke, run by VA Office of Research and Development at 4 sites 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 4 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akila Sanjay, BA ((508) 856-0104, akila.sanjay@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial neglect (SN) type (Aiming SN versus Where SN) (time frame: baseline). 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?
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 23 Apr 2026.