- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02105935
Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes
Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes.
This study's objectives are:
- To prospectively examine changes in brain network activation (BNA™) from baseline to recovery (i.e., return to activity) in youth and adolescent athletes with concussion.
- To assess the clinical utility of changes in BNA to assist in clinical decision-making.
- To generate normative BNA data.
Studienübersicht
Detaillierte Beschreibung
Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with concussion. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA™) to temporally and spatially map brain function, connectivity and synchronization.
The proposed study will provide additional evidence for the utility and contribution of the BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with concussion) in concussion management.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45229-3039
- Cincinnati children's hospital Sport center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
• Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2).
- For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and currently symptomatic
- Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
- Willingness to participate and able to give informed assent (child) and Parental consent
Exclusion Criteria:
- Currently with lice or open wounds on scalp.
- Long and thick hair that prevents the proper administration of an EEG cap.
Significant sensory deficits, e.g., deafness or blindness.
- Normative Exclusion Criteria:
- Any chronic disease as determined by clinical evaluation and medical history.
- Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
- Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
- Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation
- History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
- History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
- Substance abuse in the last 3 months.
- History of any clinically significant brain trauma as determined by the investigator.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Normative study
male and female athletes, ages 8-14.
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Baseline
male and female athletes, ages 8-18.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
Zeitfenster: 1 year
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quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
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1 year
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Gregory Myer, PhD, Children's Hospital Medical Center, Cincinnati
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
Andere Studien-ID-Nummern
- ELM-23
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Klinische Studien zur Normativ
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