NCT00990353

Brief Summary

This study examines methods to better predict improvement of a hidden disability of functional vision, spatial neglect, following stroke. Spatial neglect is a tendency to make visual judgment and movement errors mislocating the body and objects in space. The investigators are using specialized statistical methods to compute the proportion of improvement accounted for by personal characteristics of each stroke survivor, the proportion of improvement accounted for by the unique visual-spatial errors made by each subject, and the proportion of improvement accounted for by each treatment administered. The investigators will also examine whether brain imaging predicts how rapidly improvement occurs. Lastly, the study tests whether improvements that are meaningful to the survivor can be measured in a way that still allows detection of small and scientifically eloquent performance changes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

12.8 years

First QC Date

July 27, 2009

Last Update Submit

February 16, 2021

Conditions

Keywords

Spatial neglecthemineglectstrokecognitionprism adaptationHierarchical linear modelinggrowth curve modeling

Outcome Measures

Primary Outcomes (1)

  • Comparing two treatments for hidden disabilities in functional vision after stroke.

    6 months

Study Arms (2)

Prism adaptation therapy

Patients receive prism adaptation therapy by protocol (Frassinetti et al., 2002)

Bromocriptine pharmacotherapy

Patients receive bromocriptine pharmacotherapy by protocol (Barrett et al., 1999)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke survivors with right brain stroke and evidence of a hidden disability of functional vision (spatial neglect)

You may qualify if:

  • Stroke survivors with right brain stroke and evidence of a hidden disability of functional vision (spatial neglect)
  • Can give consent

You may not qualify if:

  • Other neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kessler Institute of Rehabilitation

Chester, New Jersey, 07930, United States

Location

Kessler Institute of Rehabilitation

Saddle Brook, New Jersey, 07663, United States

Location

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

  • Boukrina O, Chen P, Budinoska T, Barrett AM. Exploratory examination of lexical and neuroanatomic correlates of neglect dyslexia. Neuropsychology. 2020 May;34(4):404-419. doi: 10.1037/neu0000619. Epub 2020 Jan 30.

Related Links

MeSH Terms

Conditions

Perceptual DisordersStroke

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • A M Barrett, MD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Stroke Research

Study Record Dates

First Submitted

July 27, 2009

First Posted

October 6, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations