NCT00743821

Brief Summary

The purpose of this study is to validate and refine a diagnostic device that can detect attention and memory deficits that result from mild traumatic brain injury (mTBI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

3.9 years

First QC Date

August 28, 2008

Last Update Submit

May 5, 2014

Conditions

Post Concussive Syndrome, Chronic

Study Arms (2)

TBI Patients

Individuals who have suffered a mild traumatic brain injury and have persistent post-concussive symptoms (PCS)

Normals

Individuals of comparable age and education who have not suffered a traumatic brain injury

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

TBI patients will be recruited from an outpatient TBI clinic Normals will be friends/family of TBI patients who have not suffered a TBI, as well as individuals recruited from the community

You may qualify if:

  • Healthy volunteer
  • Education up to 12th grade

You may not qualify if:

  • History of concussion or TBI
  • Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
  • Gross visual or hearing problems
  • Pregnancy
  • Metal in the body or any contraindications for MRI
  • TBI Patients:
  • Education up to 12th grade
  • Persistent post concussive symptoms after an isolated incident of head injury with or without loss of consciousness between 3 months to 5 years prior to participation
  • Prior history of seizures
  • Pregnant woman
  • Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)
  • Gross visual or hearing problems
  • Any metal in the body or contraindications for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citigroup Imaging Center, Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain ConcussionHead Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Jamshid Ghajar, M.D., Ph.D.

    Brain Trauma Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

August 28, 2008

First Posted

August 29, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

US(1)