Brain Concussion Clinical Trial
Official title:
Effects of Neuromuscular Training on EEG Adaptations in Young Athletes
NCT number | NCT03913975 |
Other study ID # | 2014-2585 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2016 |
Est. completion date | June 30, 2017 |
Verified date | April 2019 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the current project is to determine the effects of augmented neuromuscular training on brain neuroplasticity. Specifically we aim to evaluate the potential of augmented NMT (aNMT) to alter brain neural performance as evidenced by EEG and functional brain magnetic resonance imaging (MRI). The changes in EEG and MRI (pre vs. post) will be compared over the same period of time. We hypothesize that the aNMT will influence adaptive brain strategies in young girls.
Status | Completed |
Enrollment | 38 |
Est. completion date | June 30, 2017 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years to 19 Years |
Eligibility |
Inclusion Criteria: - Healthy female athlete Exclusion Criteria: - Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview Kid (MINI-Kid) - 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 ASRS 1.0 questionnaire - 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. - History of any clinically significant brain trauma as previously diagnosed by a physician |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fMRI | changes in neural performance on fMRI from pre-post training | 12 weeks | |
Primary | EEG | changes in neural performance on EEG from pre-post training on alpha waves | 12 weeks |
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