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Pain in Traumatic Brain Injury - Basile, MD

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Rosemarie Basile, Northwell Health
ClinicalTrials.gov Identifier:
NCT01136486
First received: June 2, 2010
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
The observation through a chart review of persistent pain on neuro psychological functioning and how it applies to the community integration with patients that had suffered traumatic brain injury.

Condition
Head Trauma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Role of Persistent Pain on Neuro Psychological Functioning and Community Integration in Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Assessment of Pain Severity [ Time Frame: Referral ] [ Designated as safety issue: No ]
    Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service.


Enrollment: 56
Study Start Date: April 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:
This pilot study is designed and conducted over a one year period by the PI, who then solely carried out this study from recruitment, to patient testing, to data entry. Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
history of traumatic brain injury
Criteria

Inclusion Criteria:

  • documented history of traumatic brain injury
  • 18 years or older

Exclusion Criteria:

  • younger than 18 years old
  • cannot read and write English
  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: NCT01136486

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
  More Information

Responsible Party: Rosemarie Basile, Neuropsychologist; Clinical Coordinator, Brain Injury Program, Northwell Health
ClinicalTrials.gov Identifier: NCT01136486     History of Changes
Other Study ID Numbers: 03-015 
Study First Received: June 2, 2010
Results First Received: November 5, 2015
Last Updated: May 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Northwell Health:
head trauma; traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on December 06, 2016