Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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. Normative data will be established in healthy controls to inform objective thresholds and support clinical implementation. Concurrently, we will evaluate the safety, tolerability, and preliminary efficacy of a novel, minimal-risk multisensory therapeutic intervention (i.e., passive neurosensory reintegration training, or PNRT) for individuals with sub-acute or chronic mTBI. By addressing critical gaps in both diagnosis and treatment, this project will improve mTBI recovery outcomes, inform future clinical trials, and advance evidence-based mTBI care guidelines.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 having an unexpected neurosensory perception and unexplained by any other known etiology ("sudden neurosensory events" or SNEs)

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 changes, mood changes, cognitive fog) lasting over 4 weeks to 3 months (sub-acute), or over 3 months (chronic) following brain injury

Disqualifiers

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

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

Presence of severe aphasia

History of diagnosed psychiatric disorder or autoimmune/rheumatologic conditions prior to brain injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • Passive neurosensory reintegration training (PNRT)

    Device

    PNRT is a non-invasive, device-based system that delivers synchronized visual, vestibular, auditory, and somatosensory stimulation. The system consists of a light box and motion platform. Participants remain supine while receiving filtered halogen light at \<10 lux intensity (non-laser, non-UV) synchronized with controlled stimuli.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Passive Neurosensory Reintegration Training (PNRT)Experimental treatment 1 intervention
Group B: No Intervention - ControlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Dizziness Handicap Inventory (DHI) Total Score

Within-subject change in DHI total score from baseline to Day 13 following Passive Neurosensory Reintegration Training (PNRT). The mean change will be reported with 95% confidence intervals. Additionally, the proportion of participants achieving ≥18-point reduction in DHI score will be calculated as having clinically meaningful improvement.

Time frame
Baseline to Day 13 (Post-Intervention)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.