- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Houston Methodist Neurological Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Experimentell: Diagnostischer mTBI
MRT-Diagnose von Patienten mit leichter traumatischer Hirnverletzung (mTBI)
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Im Handel erhältlicher MRT-Scanner mit Prüf- oder Standard-MR-Spulen und einer Reihe von Prüfanwendungspaketen, die einen vorgegebenen Satz von MRT-Pulssequenzen enthalten
Andere Namen:
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Placebo-Komparator: Experimentell: Diagnose ohne mTBI
MRT-Diagnose von nicht verletzten Probanden, die eng mit mTBI übereinstimmen
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Im Handel erhältlicher MRT-Scanner mit Prüf- oder Standard-MR-Spulen und einer Reihe von Prüfanwendungspaketen, die einen vorgegebenen Satz von MRT-Pulssequenzen enthalten
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
mTBI-Progression angezeigt durch klinisch-neurologische Merkmale, MRT-Bilder und quantitative MRT-Daten von neuartiger Software
Zeitfenster: Baseline bis 3 Monate
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Zur Bestimmung von Zusammenhängen zwischen klinischen neurologischen Daten, MR-Bildern, quantitativen Daten aus neuartiger Software-Nachbearbeitung (vom Sponsor entwickelte Software, einschließlich Volumetrie, Kurtosis, Ruhezustand [RS], funktioneller Magnetresonanztomographie [fMRT] und zusätzlichen Nachbearbeitungsmodulen bereitgestellt
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Baseline bis 3 Monate
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Joseph C Masdeu, MD. PhD, Houston Methodist Neurological Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 114-2014-GES-0046
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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