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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01797549
Other study ID # 0189AP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date December 31, 2015

Study information

Verified date January 2019
Source Uniformed Services University of the Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Able to read, write, speak and understand English

- history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria:

1. GCS 3 - 12

2. Post-traumatic amnesia > 24 hours

3. TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e. documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history is indicative that the patient suffered a TBI and meets the inclusion criteria)

Exclusion Criteria:

- Multiple sclerosis, pre- or co-existing

- Stroke (other than stroke at the time of TBI)

- Pre-existing developmental disorder

- Pre-existing epilepsy

- Pre-existing major depressive disorder

- Pre-existing schizophrenia

Study Design


Locations

Country Name City State
United States Center for Neuroscience and Regenerative Medicine (CNRM) Rockville Maryland

Sponsors (2)

Lead Sponsor Collaborator
Uniformed Services University of the Health Sciences Center for Neuroscience and Regenerative Medicine (CNRM)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chernomordik V, Amyot F, Kenney K, Wassermann E, Diaz-Arrastia R, Gandjbakhche A. Abnormality of low frequency cerebral hemodynamics oscillations in TBI population. Brain Res. 2016 May 15;1639:194-9. doi: 10.1016/j.brainres.2016.02.018. Epub 2016 Mar 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of hemodynamic response function In two population groups: TBI and non TBI, we will determine normative data for the cognitive parametric experiment by measuring the local hemodynamic response function with functional near infrared spectroscopy Two years
Secondary Measure of the degree of impairment Determine the relationship between hemodynamic response as measured by fNIRS and measures of neuropsychological and behavioral functioning obtained using measures from the NINDS Common Data Elements. Two years
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