This trial is active, not recruiting.

Conditions spatial neglect, aphasia, stroke
Treatment prism adaptation treatment
Phase phase 1/phase 2
Sponsor Kessler Foundation
Start date February 2014
End date December 2016
Trial size 105 participants
Trial identifier NCT02068664, R-802-13


The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
prism adaptation treatment
prism adaptation treatment prism adaptation treatment
Prism goggles shift the image one sees toward the left (because the thicker portion of the glass lens is on the right). This will change the perception of where the image is in space, causing the person to adapt. The after-effects of the treatment is what is important. It has been shown to make it easier for people to move in the right space (if have right neglect) or improves ability to complete other functional tasks.

Primary Outcomes

Kessler Foundation Neglect Assessment Process
time frame: 2 weeks

Secondary Outcomes

Behavior Inattention Test
time frame: 2 weeks
Barthel Index
time frame: 2 weeks
University of Alabama at Birmingham (UAB) Life Space assessment
time frame: 2 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - A stroke survivor with aphasia who is a member at the Adler Aphasia Center Exclusion Criteria: - Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers

Additional Information

Official title An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia With Option of Prism Adaptation Treatment (PAT) Protocol
Principal investigator Kimberly Hreha, OT
Description Spatial neglect is a disorder that may occur after a brain injury such as stroke. Spatial neglect may affect stroke recovery. One example of this heterogeneous condition: Individuals with spatial neglect often pay more attention to one side of what they are looking at, even though they have no difficulty seeing. The study investigators would like to screen stroke survivors with aphasia because they may also have spatial neglect (right neglect after left hemisphere stroke), which is said by the literature to occur in 25% of cases. If it is identified, a treatment approach will be offered, to attempt to remediate the condition using prism goggles, following a prism treatment protocol based on previous studies.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Kessler Foundation.