Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury (NCT07356167) | Clinical Trial Compass
RecruitingNot Applicable
Passive Neurosensory Reintegration Training as a Tool to Augment Mild Traumatic Brain Injury
United States80 participantsStarted 2025-12-15
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
â. Adults aged 18 or older
â. 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)
â. Glasgow Coma Scale (GCS) score of 13-15 at the time of injury
â. 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
â. 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
â. 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
What they're measuring
1
Change in Dizziness Handicap Inventory (DHI) Total Score