Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation

NCT ID: NCT05983185

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2027-12-31

Brief 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. 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.

Conditions

Spatial Neglect After Right Brain Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Prism adaptation Therapy

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.

Group Type: ACTIVE_COMPARATOR

Prism adaptation therapy

Intervention Type: BEHAVIORAL

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.

No spatial neglect

People without spatial neglect symptoms will not receive an intervention for spatial neglect.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prism adaptation therapy

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Prism training, PAT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna M. Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

VA Central Western Massachusetts Healthcare System, Leeds, MA

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Site Status: RECRUITING

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, United States

Site Status: RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Shenette

Role: CONTACT

lisa.shenette@va.gov

(413) 463-1835

Anna M Barrett, MD

Role: CONTACT

Anna.Barrett2@va.gov

Facility Contacts

Mychaela Eatmon

Role: primary

mychaela.eatmon@va.gov

404-725-3256

Michael Dattilo, MD

Role: backup

michael.datillo@va.gov

4043216111 ext. 20660

Stacey W Wainaina

Role: primary

Stacey.Wainaina@va.gov

413-584-4040

Anna M Barrett, MD

Role: backup

Anna.Barrett2@va.gov

Jessica McCabe, PT

Role: primary

jessica.mccabe@va.gov

216-791-3800 ext. 8203830

Svetlana Pundik

Role: backup

svetlana.pundik@va.gov

2167913800 ext. 63732

Other Identifiers

C3662-R

Identifier Type: -

Identifier Source: org_study_id