Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07356167

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

Led by University of Miami · Updated on 2026-01-21

80

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 or older
  • Clear injury to the head or sudden neurosensory symptoms under 24 hours unexplained by other causes
  • Glasgow Coma Scale score between 13 and 15 at injury
  • Observed or reported signs at injury or neurosensory symptoms lasting 4 weeks to 3 months (sub-acute) or more than 3 months (chronic) after injury
Not Eligible

You will not qualify if you...

  • Moderate to severe traumatic brain injury (penetrating trauma, GCS under 13, loss of consciousness over 30 minutes, post-traumatic amnesia over 24 hours, or brain hemorrhage)
  • History of 4 or more clinically diagnosed mild traumatic brain injuries requiring emergency care (for mTBI group), or any mTBI history within 12 months or current mTBI symptoms (for control group)
  • Severe aphasia
  • Diagnosed psychiatric or autoimmune/rheumatologic disorders prior to brain injury, including conditions like Lyme disease, POTS, Ehlers-Danlos syndrome, long COVID, severe depression, schizophrenia, or lupus
  • Documented neurological disorders such as epilepsy, stroke, or dementia
  • Legal blindness defined by severe vision loss
  • History of brain or central nervous system tumor
  • Currently receiving vision therapy for mTBI-related visual impairment
  • Wards of the state or prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

E

Erin Williams, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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