Pain in Traumatic Brain Injury - Basile, MD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136486
Recruitment Status : Terminated (slow accrual)
First Posted : June 3, 2010
Results First Posted : May 24, 2016
Last Update Posted : May 24, 2016
Information provided by (Responsible Party):
Rosemarie Basile, Northwell Health

Brief Summary:
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 or disease
Head Trauma

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.

Study Type : Observational
Actual Enrollment : 56 participants
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
Study Start Date : April 2003
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Assessment of Pain Severity [ Time Frame: Referral ]
    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.

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136486

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

Responsible Party: Rosemarie Basile, Neuropsychologist; Clinical Coordinator, Brain Injury Program, Northwell Health Identifier: NCT01136486     History of Changes
Other Study ID Numbers: 03-015
First Posted: June 3, 2010    Key Record Dates
Results First Posted: May 24, 2016
Last Update Posted: May 24, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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