Mild Traumatic Brain InjuryPNRT for mTBINCT07356167
Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
A study testing Passive neurosensory reintegration training (PNRT) in people with Mild Traumatic Brain Injury, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Passive neurosensory reintegration training (PNRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami Miller School of Medicine - Don Soffer Clinical Research Building
Miami, Florida, 33136
Erin Williams, Ph.D., 305-243-8959, erin.williams@med.miami.edu
About this study
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
- Mild Traumatic Brain Injury
- Being tested
- Passive neurosensory reintegration training (PNRT)
- Keywords
- mTBI, mild traumatic brain injury, TBI, visuo-vestibular dysfunction, vestibular dysfunction
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Passive Neurosensory Reintegration Training (PNRT) | Experimental | 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). Receives: Device: Passive neurosensory reintegration training (PNRT) |
| No Intervention - Controls | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dizziness Handicap Inventory (DHI) Total Score
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.
Measured: Baseline to Day 13 (Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Williams, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356167
- Sponsor's protocol ID
- 20250973
- Acronym
- PNRT for mTBI
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications may be made available to qualified researchers upon reasonable request, following publication of primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07356167
- Acronym / sponsor ID
- PNRT for mTBI / 20250973
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mTBI, mild traumatic brain injury, TBI, visuo-vestibular dysfunction, vestibular dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Neurosensory Reintegration Training (PNRT) | Experimental | Device: 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 - Controls | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- Documented neurological disorders (e.g., epilepsy, stroke, dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive 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. | Device | Passive Neurosensory Reintegration Training (PNRT) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in publications may be made available to qualified researchers upon reasonable request, following publication of primary study results.
Related trials for Mild Traumatic Brain Injury
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Not yet recruiting
Sleep MAPP in the Polytrauma/TBI System of Care
Insomnia Disorder, Mild Traumatic Brain Injury
Recruiting
EXercise-induced PhysioLogical Adaptations In Neurological Disorders
Epilepsy, Functional Neurological Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive neurosensory reintegration training (PNRT) in people with Mild Traumatic Brain Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Williams, Ph.D. (305-243-8959, erin.williams@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dizziness Handicap Inventory (DHI) Total Score (time frame: Baseline to Day 13 (Post-Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.