Passive neurosensory reintegration training to help recovery after mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project combines established mTBI screening and clinical neuro‑optometric exams with high-resolution oculomotor, vestibular, and reaction time (OVRT) testing to improve diagnostic precision and identify prognostic markers of recovery. Normative OVRT data will be collected from healthy controls to establish objective thresholds for clinical use. Concurrently, adults with sub-acute or chronic mTBI will receive a novel, low-risk multisensory intervention called passive neurosensory reintegration training (PNRT) to evaluate safety, tolerability, and preliminary efficacy. Outcomes will include symptom changes, objective OVRT measures, and functional recovery indicators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 or older
2. 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 having an unexpected neurosensory perception and unexplained by any other known etiology ("sudden neurosensory events" or SNEs)
3. Glasgow Coma Scale (GCS) score of 13-15 at the time of injury
4. 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 changes, mood changes, cognitive fog) lasting over 4 weeks to 3 months (sub-acute), or over 3 months (chronic) following brain injury

Exclusion Criteria:

1. Any of the following: moderate to severe TBI characterized by penetrating head trauma, GCS \<13 at the time of injury, LOC \>30 minutes or PTA \>24 hours, subdural or epidural hemorrhage for most recent occurence
2. 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 mTBI-related symptoms at time of enrollment
3. Presence of severe aphasia
4. History of diagnosed psychiatric disorder or autoimmune/rheumatologic conditions prior to brain injury

   1. Uncontrolled autoimmune/rheumatologic conditions including but not limited to Lyme, POTS, EDS, long COVID
   2. Psychiatric disorders: including but not limited to severe depression, schizophrenia, lupus)
5. Documented neurological disorders (e.g., epilepsy, stroke, dementia)
6. 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)
7. History of tumor of the brain or central nervous system
8. Actively receiving vision therapy for current mTBI-related visual-impairment
9. Wards of the state or prisoners

Where it's running

• University of Miami Miller School of Medicine - Don Soffer Clinical Research Building
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Erin Williams, Ph.D.
• Email: erin.williams@med.miami.edu
• Phone: 305-243-8959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.