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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07356167
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Passive Neurosensory Reintegration Training (PNRT)
    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).
  • No Intervention: No Intervention - Controls
    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.

Primary Outcome Measure

Change in Dizziness Handicap Inventory (DHI) Total Score [ Time Frame: Baseline to Day 13 (Post-Intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Miller School of Medicine - Don Soffer Clinical Research BuildingMiamiFlorida33136
Erin Williams, Ph.D.
[email protected]
305-243-8959

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By research site
University of Miami Miller School of Medicine - Don Soffer Clinical Research Building· Miami, FL

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