NCT03913975

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

March 19, 2019

Last Update Submit

April 11, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • fMRI

    changes in neural performance on fMRI from pre-post training

    12 weeks

  • EEG

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

    12 weeks

Interventions

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.

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy female athlete

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Greg Myer, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

April 12, 2019

Study Start

June 1, 2016

Primary Completion

December 31, 2016

Study Completion

June 30, 2017

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations