RecruitingNot ApplicableNCT07356167

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


Sponsor

University of Miami

Enrollment

80 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Passive neurosensory reintegration training (PNRT) for people with mild traumatic brain injury. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.


Locations(1)

University of Miami Miller School of Medicine - Don Soffer Clinical Research Building

Miami, Florida, United States

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NCT07356167


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