Trials / Recruiting
RecruitingNCT07356167
Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- University of Miami · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Passive neurosensory reintegration training (PNRT) | 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. |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2026-12-31
- Completion
- 2027-05-31
- First posted
- 2026-01-21
- Last updated
- 2026-01-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07356167. Inclusion in this directory is not an endorsement.