- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02218216
TBI MR Study 3 Houston Methodist
Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3
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 involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor
Studieoversigt
Detaljeret beskrivelse
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 involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Neurological Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Eksperimentel: Diagnostisk mTBI
MR-diagnostik af personer med mild traumatisk hjerneskade (mTBI)
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Kommercielt tilgængelig MR-scanner ved hjælp af undersøgelses- eller standardbehandlings-MR-spoler og en række undersøgelsesapplikationspakker indeholdende et forudbestemt sæt MR-pulssekvenser
Andre navne:
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Placebo komparator: Eksperimentel: Diagnostisk ikke-mTBI
MR-diagnostik af ikke-skadede forsøgspersoner, der er tæt matchet med mTBI
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Kommercielt tilgængelig MR-scanner ved hjælp af undersøgelses- eller standardbehandlings-MR-spoler og en række undersøgelsesapplikationspakker indeholdende et forudbestemt sæt MR-pulssekvenser
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
mTBI-progression angivet af kliniske neurologiske karakteristika, MR-billeder og kvantitative MR-data fra ny software
Tidsramme: Baseline til 3 måneder
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For at bestemme sammenhænge mellem kliniske neurologiske data kan MR-billeder, kvantitative data fra ny software-efterbehandling (sponsorudviklet software, herunder Volumetry, Kurtosis, Resting State [RS], funktionel magnetisk resonansbilleddannelse [fMRI] og yderligere efterbehandlingsmoduler stillet til rådighed
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Baseline til 3 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Joseph C Masdeu, MD. PhD, Houston Methodist Neurological Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 114-2014-GES-0046
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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