Prism Adaptation Therapy for Spatial Neglect

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Kessler Foundation
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00989430
First received: October 2, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke.

This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.


Condition Intervention
Spatial Neglect
Deficits in Attention Motor Control and Perception
Behavioral: Prism Adaptation Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prism Adaptation Therapy for Spatial Neglect: Theoretical and Practical Outcomes

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Improvement in Spatial Neglect [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prism Adaptation Treatment
Two weeks of prism adaptation treatment followed by 4 weekly assessments and long-term follow-ups at the 3rd and 6th months.
Behavioral: Prism Adaptation Treatment
Wearing prism goggles and performing visuomotor tasks during therapy sessions.
No Intervention: Control: Standard Rehabilitation Care
Participants will continue with their standard inpatient rehabilitation care. They will be assessed with cognitive and functional scales for tracking their recovery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is 18 to 100 years of age, inclusive.
  • The subject has had a stroke on the right side of the brain.
  • The subject is able to give Informed consent.
  • The subject has a spatial neglect (if known).
  • The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.

Exclusion Criteria:

  • The subject has or had a serious brain condition other than stroke.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989430

Contacts
Contact: A. M. Barrett, MD 973-324-3522 abarrett@kesslerfoundation.org
Contact: Jenny Masmela, BA 973-324-3564 jmasmela@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny Masmela, BA    973-324-3564    jmasmela@kesslerfoundation.org   
Principal Investigator: Anna M Barrett, MD         
Sponsors and Collaborators
Kessler Foundation
U.S. Department of Education
Investigators
Principal Investigator: Anna M Barrett, MD Kessler Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: A. M. Barrett, MD, Director, Stroke Rehabilitation Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00989430     History of Changes
Other Study ID Numbers: AMBarrett3, Spatial Neglect
Study First Received: October 2, 2009
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
stroke
CVA
cerebrovascular accident
rehabilitation

Additional relevant MeSH terms:
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014