Passive Neurosensory Reintegration Training for Concussion
(PNRT for mTBI Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Are You a Good Fit for This Trial?
This trial is for individuals with mild traumatic brain injury (mTBI) or concussion, who may be experiencing ongoing neurosensory and cognitive symptoms. The study aims to refine diagnostic methods and test a new therapy called passive neurosensory reintegration training (PNRT).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Passive Neurosensory Reintegration Training (PNRT) over 12 sessions in approximately two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Passive Neurosensory Reintegration Training
Trial Overview
The trial is testing the effectiveness of PNRT in treating persistent symptoms after mTBI. It includes detailed assessments using oculomotor, vestibular, and reaction time tests to establish normative data for better diagnosis and prognosis.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Passive Neurosensory Reintegration Training (PNRT), a multisensory neuromodulation protocol integrating synchronized visual, vestibular, auditory, and somatosensory inputs to promote sensory reintegration and recovery of balance and oculomotor function. Each participant will complete 12 sessions over approximately two weeks (Days 1-12). Each session lasts approximately 60 minutes and involves exposure to coordinated low-intensity light, motion, and auditory stimuli in a controlled seated position. Participants will complete standardized assessments at Baseline, Day 6 (midpoint), Day 13 (post-intervention), and Day 40 (follow-up).
Participants assigned to the control arm will receive no active intervention during the initial 13-day period. They will undergo the same schedule of baseline, midpoint (Day 6), post (Day 13), and follow-up (Day 40) assessments as the PNRT group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
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