Prism Adaptation Therapy for Spatial Neglect
This study is currently recruiting participants.
Verified May 2013 by Kessler Foundation
Sponsor:
Kessler Foundation
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Anna M. Barrett, MD, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00989430
First received: October 2, 2009
Last updated: May 1, 2013
Last verified: May 2013
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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
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: | Anna 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: | May 1, 2013 |
| 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 June 17, 2013