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New treatment option for Mild Traumatic Brain Injury
Official title Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
ClinicalTrials.gov ID: NCT07356167
What this study is testing
- What it's testing
- Mild traumatic brain injury (mTBI) poses a substantial clinical and public health burden, often leading to persistent neurosensory and cognitive symptoms for which diagnostic and therapeutic solutions remain limited. This study proposes a multimodal diagnostic framework that integrates established mTBI screening tools and clinical neuro-optometric assessments with high-resolution oculomotor, vestibular, and reaction time (OVRT) testing to enhance diagnostic precision and identify prognostic markers of 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 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adults aged 18 or older
- Clear mechanism of injury (i.e., direct or indirect impact to head), or Any individual presenting with complaints of sudden (\<24h) onset...
- Glasgow Coma Scale (GCS) score of 13-15 at the time of injury
- Observed or reported focal signs at the time of injury (e.g., loss of consciousness, amnesia, or confusion) or neurosensory symptoms (e.g...
You likely can't join if
- Any of the following: moderate to severe TBI characterized by penetrating head trauma, GCS \ 30 minutes or PTA \>24 hours, subdural or epidural...
- mTBI/SNE Group: History of 4 or more clinically diagnosed mTBIs that warranted emergent assessment in a hospital or emergency department setting...
- Presence of severe aphasia
- History of diagnosed psychiatric disorder or autoimmune/rheumatologic conditions prior to brain injury
- Uncontrolled autoimmune/rheumatologic conditions including but not limited to Lyme, POTS, EDS, long COVID
- Psychiatric disorders: including but not limited to severe depression, schizophrenia, lupus)
See the full eligibility criteria
- Adults aged 18 or older
- Clear mechanism of injury (i.e., direct or indirect impact to head), or Any individual presenting with complaints of sudden (\<24h) onset neurosensory symptoms as characterized by hearing a noise, feeling a force, or...
- Glasgow Coma Scale (GCS) score of 13-15 at the time of injury
- Observed or reported focal signs at the time of injury (e.g., loss of consciousness, amnesia, or confusion) or neurosensory symptoms (e.g., dizziness, headaches, photo/phonophobia, fatigue, vision problems, sleep...
- Any of the following: moderate to severe TBI characterized by penetrating head trauma, GCS \ 30 minutes or PTA \>24 hours, subdural or epidural hemorrhage for most recent occurence
- mTBI/SNE Group: History of 4 or more clinically diagnosed mTBIs that warranted emergent assessment in a hospital or emergency department setting Control Group: History of mTBI within the last 12 months or presence of...
- Presence of severe aphasia
- History of diagnosed psychiatric disorder or autoimmune/rheumatologic conditions prior to brain injury
- Uncontrolled autoimmune/rheumatologic conditions including but not limited to Lyme, POTS, EDS, long COVID
- Psychiatric disorders: including but not limited to severe depression, schizophrenia, lupus)
- Documented neurological disorders (e.g., epilepsy, stroke, dementia)
- Legally blind (characterized by a best-corrected visual acuity of 20/200 or less in the better eye or a visual field of 20 degrees or less)
- History of tumor of the brain or central nervous system
- Actively receiving vision therapy for current mTBI-related visual-impairment
- Wards of the state or prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, 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.