Passive neurosensory reintegration training to help recovery after mild traumatic brain injury
Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
NA · University of Miami · NCT07356167
We will try a gentle multisensory therapy called passive neurosensory reintegration training (PNRT) to see if it helps adults with sub-acute or chronic mild traumatic brain injury recover neurosensory and cognitive symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07356167 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with a clear head injury or sudden neurosensory event, GCS 13–15 at the time of injury, and neurosensory symptoms lasting more than four weeks (sub-acute) or longer than three months (chronic).
Not a fit: People with moderate-to-severe TBI (for example penetrating injury, GCS <13, prolonged loss of consciousness, extended post-traumatic amnesia), active subdural complications, or other medical explanations for symptoms are not eligible and are unlikely to benefit from PNRT in this protocol.
Why it matters
Potential benefit: If successful, PNRT could shorten recovery and reduce persistent neurosensory and cognitive symptoms while providing objective tests to guide care.
How similar studies have performed: High-resolution OVRT testing and visuo-vestibular rehabilitation approaches have shown promise in mTBI, but the PNRT multisensory intervention itself is novel and has limited prior outcome data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mild Traumatic Brain Injury, mTBI, mild traumatic brain injury, TBI, visuo-vestibular dysfunction, vestibular dysfunction