80 Participants Needed

Passive Neurosensory Reintegration Training for Concussion

(PNRT for mTBI Trial)

EW
Overseen ByErin Williams, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the diagnosis and treatment of mild traumatic brain injuries (mTBI), commonly known as concussions. It tests a new treatment called Passive Neurosensory Reintegration Training (PNRT), which uses light, sound, and motion to alleviate symptoms like dizziness, headaches, and difficulty concentrating. The trial seeks participants who have experienced a concussion with ongoing symptoms lasting more than four weeks but less than three months, or more than three months. Participants will attend multiple sessions over two weeks to assess symptom improvement. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future concussion care.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for individuals with mTBI?

Research shows that Passive Neurosensory Reintegration Training (PNRT) is a low-risk treatment. It aims to help people with mild traumatic brain injury (mTBI) by using light, movement, and sound to improve how the brain processes sensory information. Although solid data on its safety is limited, "low-risk" indicates that any side effects are likely minor. Previous studies on similar treatments for brain injury recovery have focused on improving sensory and motor skills without major problems reported. This suggests that PNRT might be well-tolerated, but more research is needed to confirm its safety.12345

Why are researchers excited about this trial?

Researchers are excited about Passive Neurosensory Reintegration Training (PNRT) for concussion because it offers a novel approach by integrating multiple sensory inputs—visual, vestibular, auditory, and somatosensory—to help restore balance and eye movement functions. Unlike traditional concussion treatments, which often focus on rest and gradual return to activity, PNRT actively engages the brain through synchronized stimuli. This multisensory neuromodulation could potentially speed up recovery and improve outcomes by promoting sensory reintegration, offering hope for faster and more effective concussion rehabilitation.

What evidence suggests that Passive Neurosensory Reintegration Training is effective for mild traumatic brain injury?

Research shows that passive neurosensory reintegration training (PNRT), which participants in this trial may receive, might help people recover from mild traumatic brain injury (mTBI). This treatment uses various senses, such as sight, sound, and movement, to aid brain healing. Studies suggest that similar methods have successfully improved balance and eye movement control after brain injuries. Although direct data on PNRT remains limited, evidence from related therapies supports its potential. Early results indicate it could enhance current treatments, possibly leading to faster and more complete recovery.678910

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

I am 18 years old or older.
I experienced a head injury or sudden symptoms like hearing noises without a known cause.
Glasgow Coma Scale (GCS) score of 13-15 at the time of injury
See 1 more

Exclusion Criteria

I had a severe head injury with significant symptoms or findings.
I have had 4 or more mild TBIs needing emergency care or had a mild TBI recently.
I have a history of psychiatric or autoimmune conditions before my brain injury.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Passive Neurosensory Reintegration Training (PNRT) over 12 sessions in approximately two weeks

2 weeks
12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) on Day 40

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

Group I: Passive Neurosensory Reintegration Training (PNRT)Experimental Treatment1 Intervention
Group II: No Intervention - ControlsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Citations

Passive Neurosensory Reintegration Training as a Tool to ...

By addressing critical gaps in both diagnosis and treatment, this project will improve mTBI recovery outcomes, inform future clinical trials, ...

The Outcome of Neurorehabilitation Efficacy and Management ...

Placebo-Controlled trial of familiar auditory sensory training for acute severe traumatic brain injury: a preliminary report. Neurorehabil ...

Update on the Efficacy of Cognitive Rehabilitation After ...

Forty-three studies reported significant effects of cognitive rehabilitation, among which 7 fulfilled a high methodological level of evidence.

137 Concussion Trials Near You

This trial is testing a new treatment called PST-Concussion to help Veterans with mild traumatic brain injury manage their symptoms.

RULE 17, EXHIBIT 2A - Mild Traumatic Brain Injury Medical ...

The qualified practitioner (optometrist, neuro-optometrist, ophthalmologist, neuro-ophthalmologist) should have training and experience in the neurology of TBI.

Passive Neurosensory Reintegration Training as a Tool to ...

Concurrently, we will evaluate the safety, tolerability, and preliminary efficacy of a novel, minimal-risk multisensory therapeutic intervention ...

EARLY TEAM BASED NEURO-REHABILITATION AFTER ...

Abstract. Objective. Evaluate study design, procedure, and measurements for future study of early rehabilitation after mild traumatic brain injury.

motor and sensory impairment rehabilitation post ... - ERABI

training may improve olfactory dysfunction in individuals with moderate to severe TBI. Non-Pharmacological Interventions for Pain and Post Traumatic Headache.

Can Early Initiation of Rehabilitation With Wearable Sensor ...

The investigators hypothesize that retraining the brain early, as opposed to months after injury, to correctly interpret sensory information ...

Traumatic brain injury: integrated approaches to improve ...

Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. December 2017; The Lancet Neurology 16(12).