Status:
TERMINATED
TBI MR Study 3 Houston Methodist
Lead Sponsor:
GE Healthcare
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
15-50 years
Phase:
NA
Brief Summary
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings...
Detailed Description
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings i...
Eligibility Criteria
Inclusion
- Segment 1 (mTBI patient) Inclusion and Exclusion Criteria Inclusion Criteria for mTBI subjects
- Subjects included in the main part of this study (Segment 1) will:
- Be aged ≥15 and ≤50 years old at the time of enrollment;
- Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the first two intervals of the study, as follows:
- Meets criteria for enrollment in Encounter 1 (within 72 hours), or
- Meets criteria for enrollment in Encounter 2 (within 8±2 days)
- Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
- Segment 1: Exclusion Criteria for mTBI subjects
- Subjects will be excluded that have:
- Loss of consciousness (LOC) ≥15 minutes;
- Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;
- Diagnosis of moderate to severe TBI or GCS \<13;
- Structural brain injury indicated by previous neuroimaging findings;
- Previous history of moderate to severe TBI;
- Any previous history of mild TBI within the past 12 months;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of self-reported illicit drug abuse (except marijuana) in past 10 years;
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix F - Screening for Exclusion based on Axis I or II Disorders):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
- Known structural brain disease or malformation;
- Current anti-psychotic or antiepileptic medication usage;
- That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
- Contraindications to MRI scanning, including:
- Current or suspected pregnancy per site clinical practice;
- Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
- Inability to comply with any part of the site's MR safety policy.
- Segment 2 (non-TBI subject) Inclusion and Exclusion Criteria Inclusion Criteria for Non-TBI subjects (Segment 2)
- All included subjects will:
- Aged ≥15 and ≤50 years old at the time of enrollment;
- Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:
- Age,
- Gender,
- Sociodemographic characteristics, and
- Handedness.
- Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
- Exclusion Criteria for Non-TBI subjects (Segment 2)
- Subjects will be excluded that:
- Are currently pregnant based on subject self-report of pregnancy status;
- Are currently enrolled in another Segment of this study;
- Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
- Prior diagnosis of mild TBI within the past 12 months;
- Have structural brain injury indicated by previous neuroimaging findings;
- Previous history of moderate to severe TBI within the past 10 years;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of illicit drug abuse (except marijuana) within the past 10 years
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix F - Screening for Exclusion based on Axis I or II Disorders):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
- Known structural brain disease or malformation;
- Current anti-psychotic or antiepileptic medication usage;
- Have contraindications to MRI scanning, including:
- Current or suspected pregnancy per site clinical practice;
- Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
- Inability to comply with any part of the site's MR safety policy.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02218216
Start Date
September 1 2014
End Date
November 1 2015
Last Update
July 24 2017
Active Locations (1)
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1
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030