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NCT Number: NCT07356167

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

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Erin Williams, Ph.D.

CONTACT

[email protected]

305-243-8959

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 or older
Clear mechanism of injury (i.e., direct or indirect impact to head), or Any individual presenting with complaints of sudden (<24h) onset neurosensory symptoms as characterized by hearing a noise, feeling a force, or having an unexpected neurosensory perception and unexplained by any other known etiology ("sudden neurosensory events" or SNEs)
Glasgow Coma Scale (GCS) score of 13-15 at the time of injury
Observed or reported focal signs at the time of injury (e.g., loss of consciousness, amnesia, or confusion) or neurosensory symptoms (e.g., dizziness, headaches, photo/phonophobia, fatigue, vision problems, sleep changes, mood changes, cognitive fog) lasting over 4 weeks to 3 months (sub-acute), or over 3 months (chronic) following brain injury

Exclusion criteria

Any of the following: moderate to severe TBI characterized by penetrating head trauma, GCS <13 at the time of injury, LOC >30 minutes or PTA >24 hours, subdural or epidural hemorrhage for most recent occurence
mTBI/SNE Group: History of 4 or more clinically diagnosed mTBIs that warranted emergent assessment in a hospital or emergency department setting Control Group: History of mTBI within the last 12 months or presence of mTBI-related symptoms at time of enrollment
Presence of severe aphasia
History of diagnosed psychiatric disorder or autoimmune/rheumatologic conditions prior to brain injury

Uncontrolled autoimmune/rheumatologic conditions including but not limited to Lyme, POTS, EDS, long COVID
Psychiatric disorders: including but not limited to severe depression, schizophrenia, lupus)
Documented neurological disorders (e.g., epilepsy, stroke, dementia)
Legally blind (characterized by a best-corrected visual acuity of 20/200 or less in the better eye or a visual field of 20 degrees or less)
History of tumor of the brain or central nervous system
Actively receiving vision therapy for current mTBI-related visual-impairment
Wards of the state or prisoners

Treatment and study plan

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.

Primary outcomes

Change in Dizziness Handicap Inventory (DHI) Total Score

Time frame: Baseline to Day 13 (Post-Intervention)

Within-subject change in DHI total score from baseline to Day 13 following Passive Neurosensory Reintegration Training (PNRT). The mean change will be reported with 95% confidence intervals. Additionally, the proportion of participants achieving ≥18-point reduction in DHI score will be calculated as having clinically meaningful improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Williams, Ph.D.

CONTACT

[email protected]

305-243-8959

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: PNRT for mTBI

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jan 21, 2026
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting