- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Ohio
-
Cincinnati, Ohio, Verenigde Staten, 45229-3039
- Cincinnati children's hospital Sport center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Normative study
male and female athletes, ages 8-14.
|
|
Baseline
male and female athletes, ages 8-18.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
Tijdsspanne: 1 year
|
quantitative and qualitative analysis of brain network activation (BNA) in participants that have sustained concussion compared to their baseline test.
|
1 year
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Gregory Myer, PhD, Children's Hospital Medical Center, Cincinnati
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- ELM-23
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .