Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation

NCT05983185 | Recruiting

• 1 other identifier: C3662-R
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 4

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.

Conditions

Spatial Neglect After Right Brain Stroke

Keywords

spatial neglect; cognition; stroke rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  5 weeks after enrollment

Secondary Outcomes (2)

• SN severity, as assessed by the Behavioral Inattention Test-conventional subtest (BIT-c)

  5 weeks after enrollment

• SN severity, as assessed by the Catherine Bergego Scale (CBS)

  5 weeks after enrollment

Study Arms (2)

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.

Behavioral: Prism adaptation therapy

No spatial neglect

NO INTERVENTION

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

Interventions

Prism adaptation therapy 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.

Also known as: Prism training, PAT

Prism adaptation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has had a first right brain stroke \>18 years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

Study Officials

• Anna M. Barrett, MD

  VA Central Western Massachusetts Healthcare System, Leeds, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akila Sanjay, BA

CONTACT

(508) 856-0104; akila.sanjay@va.gov

Anna M Barrett, MD

CONTACT

Anna.Barrett2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will not be aware of the location of the Veteran's stroke.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators are examining predictors of treatment response, hypothesized to relate to brain imaging biomarkers.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 9, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)