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New treatment option for Mild Traumatic Brain Injury, Concussion
Official title Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation
ClinicalTrials.gov ID: NCT06381674
What this study is testing
- What it's testing
- Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI.
- Which group you join is decided by chance.
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 60
You may be able to join if
- For all Aims, participants may be either civilians, active duty military, or Veterans, and must:
- have a diagnosis of mTBI based on VA/DoD criteria
- be between 18-60 years old,
- be able to stand unassisted for 10 minutes at a time
- be outside of the acute stage (\> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms
You likely can't join if
- Participants must not:
- have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., CNS...
- meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V
- display behavior that would significantly interfere with the validity of data collection or safety during the study
- be in significant pain during the evaluation (\> 7/10 by patient subjective report)
- be a pregnant female (balance considerations)
See the full eligibility criteria
- For all Aims, participants may be either civilians, active duty military, or Veterans, and must:
- have a diagnosis of mTBI based on VA/DoD criteria
- be between 18-60 years old,
- be able to stand unassisted for 10 minutes at a time
- be outside of the acute stage (\> 2 weeks post-concussion) but within 6 months of their most recent mTBI and still reporting symptoms
- have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen
- have sufficient vision (corrected or uncorrected) for unassisted reading and performance of everyday personal tasks and independent community ambulation
- have adequate hearing (without amplification) adequate for engaging in close-range personal or telephone conversation.
- Participants must not:
- have had or currently have any other injury, medical, or neurological illness that could potentially explain balance or vision deficits (e.g., CNS disease, stroke, epilepsy, greater than mild TBI, Meniere's, bilateral...
- meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V
- display behavior that would significantly interfere with the validity of data collection or safety during the study
- be in significant pain during the evaluation (\> 7/10 by patient subjective report)
- be a pregnant female (balance considerations)
- been hospitalized for any brain injuries (separate from the emergency department)
- have significant joint pain or recent musculoskeletal injury that limits walking or mobility
- have had any major surgeries in the past year or amputation
- use an assistive device
- unable to stand barefoot
- currently receiving rehabilitation services for their mTBI or injuries related to their concussion (if rehabilitation has been completed more than 1 month ago participants may still be included).
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States; San Antonio, Texas, United States; Salt Lake City, Utah, 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.