NCT02366442

Brief Summary

The overarching goal of the proposed study, named SYNERGY, is to explore relationships among balance performance, cognitive function, affective dysregulation, as they relate to the community re-integration in Veterans with TBI. The SYNERGY study findings can aid in the development of a better outcome models for the clinicians in facilitating effective community re-integration in Veterans with TBI

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

February 11, 2015

Last Update Submit

February 18, 2015

Conditions

Traumatic Brain InjuryTBI

Keywords

dual/multitaskingExecutive functionAffective functionBalance

Outcome Measures

Primary Outcomes (1)

  • Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).

    1-2 year

Interventions

Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).OTHER

Eligibility Criteria

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

Veterans with the diagnosis of TBI

You may not qualify if:

  • The result of VHA TBI Comprehensive Evaluation electronic template will be reviewed following IRB approved and HIPAA compliant data collection procedures. The TBI diagnosis will be obtained from patient's chart review of problem section and physician's notes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow at polytrauma/TBI at DCVAMC

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 19, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 19, 2015

Record last verified: 2015-02