NCT01136486

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2003

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
6 years until next milestone

Results Posted

Study results publicly available

May 24, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

6.7 years

First QC Date

June 2, 2010

Results QC Date

November 5, 2015

Last Update Submit

May 23, 2016

Conditions

Keywords

head trauma; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Assessment of Pain Severity

    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.

    Referral

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

history of traumatic brain injury

You may qualify if:

  • documented history of traumatic brain injury
  • years or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Results Point of Contact

Title
Dr. Rosemarie Basile
Organization
North Shore LIJ

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neuropsychologist; Clinical Coordinator, Brain Injury Program

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

April 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 24, 2016

Results First Posted

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations