BridgeMD
New treatment option for Brain Concussion
Official title Exercise Reset for Concussion in a Military Environment
ClinicalTrials.gov ID: NCT05498038
What this study is testing
- What it's testing
- Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- (Participants): For the CSM Group:
- Active-duty service member
- Aged 18-40 years
- Injury occurred within 9 days of injury
- Diagnosed with concussion by an experienced clinician using standard international criteria For the HC Group:
You likely can't join if
- (Participants): For the CSM group:
- Moderate or severe TBI as indicated by a GCS score \<13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion
- Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \>24 hours
- Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk
- Pre-existing conditions that prevent participation in active testing and/or rehabilitation
- Active substance abuse/dependence
See the full eligibility criteria
- (Participants): For the CSM Group:
- Active-duty service member
- Aged 18-40 years
- Injury occurred within 9 days of injury
- Diagnosed with concussion by an experienced clinician using standard international criteria For the HC Group:
- Active-duty service member
- Ages 18-40
- (Participants): For the CSM group:
- Moderate or severe TBI as indicated by a GCS score \<13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion
- Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \>24 hours
- Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk
- Pre-existing conditions that prevent participation in active testing and/or rehabilitation
- Active substance abuse/dependence
- Unwillingness to perform intervention
- Limited English proficiency
- Confirmed pregnancy For the HC group:
- Has lingering symptoms from a previous concussion or has recovered from a concussion less than 1-month ago
- On a limited profile or "chit" for light duty
- Active substance abuse/dependence
- Unwilling to perform intervention
- Limited English proficiency
- Confirmed pregnancy Inclusion Criteria (Providers):
- Active duty
- Currently active clinician (MD, DO, PT, ATC, OT) involved in concussion management beyond initial emergent diagnosis
- Willing to participate
- Able to be contacted by telephone or Zoom Exclusion Criteria (Providers):
- Not active duty
- Not currently an active clinician (MD, DO, PT, ATC, OT) involved in concussion management
- Only involved in concussion management at emergent timepoint
- Unwilling to participate
- Unable to be contacted by telephone or Zoom
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, North Carolina, United States
- Jacksonville, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, North Carolina, United States; Jacksonville, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.