Clinical Trials Directory

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

TypeNameDescription
DEVICEPassive 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.