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CompletedNCT03913975Updated Apr 12, 2019

Effects of Neuromuscular Training on EEG Adaptations in Young Athletes

An interventional study of Neuromuscular training in Brain Concussion, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to female participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-12.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jun 2016, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
13 Years to 19 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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 standard 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 aNMT will influence adaptive brain strategies in young girls and simultaneously will improve joint mechanics in evidence-based measures collected in realistic, sport-specific virtual reality scenarios. The human brain is a highly complex multilayered organ composed of many billions of neurons (1 trillion brain cells and 100 billion neurons), organized into very complicated interconnecting neural networks. Typically, each neuron is connected to tens of thousands of other neurons through connections called synapses. Electrochemical signals that are passed between neurons through these synapses allow them to communicate. The connections between neurons are not static, but change over time. The more signals sent between two neurons, the stronger the connection grows, and so, with each new experience, the brain slightly rewires its physical and functional structure.

Unique local physical and functional connections between neurons are called neural networks. Neural networks are typically characterized by preferred signaling pathways, and it is the interactions within and between these networks of neurons that enable us to perform various functions including cognitive functions, such as attention, working memory, pattern recognition and problem-solving. It is this simultaneous cooperative function of brain areas working together as large-scale networks which is at the root of the sophistication and computational power of the human brain.

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 measure, as they provide both a noninvasive and portable index 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 has improved significantly.

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.

The BNA test is basically divided to 3 phases - first EEG data is collected from subjects using an EEG system and while the subject is performing a computerized cognitive task. The EEG data is then analyzed using the advanced BNA™ technology and last a report of the BNA™ test is generated.

Neuroimaging, specifically functional magnetic resonance imaging provides improved spatial data relative to EEG and provides another measure of neuroplasticity to gain the full pictures of training effects on the brain. Previous literature supporting its ability to detect differences in those with ACL injury strengthens the use of fMRI. We will be assessing the full brain response during a knee extension task using previously established methods ACL deficient and reconstructed knees. Recent investigations into gait retraining with fMRI pre-post testing have created the neural correlates of gait training based on ankle dorsiflexion. In the same way, this study will apply a similar paradigm utilizing knee extension to understand the neuroplasticity associated with lower extremity neuromuscular training.

02

Conditions studied

  • Brain Concussion

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03

In context

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's enrollment of 38 is below the median of 64 across 364 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy female athlete

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Interventions

  • OtherNeuromuscular training

    The novel training program with real-time biofeedback added consists of 2 sets of 10 repetitions per session with a progression in exercise intensity (Squat: 40 repetitions during week 1; Squat Jump: 80 repetitions during weeks 2-3; Tuck Jumps: 120 repetitions during weeks 3-6) over the 6-week training period.

06

What researchers measure

Primary outcomes

  1. fMRI

    changes in neural performance on fMRI from pre-post training

    Time frame: 12 weeks

  2. EEG

    changes in neural performance on EEG from pre-post training on alpha waves

    Time frame: 12 weeks

07

Study locations

1 site
  • Cincinnati Childrens Hospital Medical Center
    Cincinnati, Ohio 45229, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03913975
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Apr 12, 2019
Start date
Jun 1, 2016
Primary completion
Dec 31, 2016
Completion
Jun 30, 2017
Last update
Apr 12, 2019

Study contacts

Greg Myer, PhD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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