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Идёт набор NCT07356167

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

Без фазы С лечением Mild Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Passive neurosensory reintegration training (PNRT).
Кому может быть актуально
Состояния в реестре: Mild Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Change in Dizziness Handicap Inventory (DHI) Total Score [Срок оценки: Baseline to Day 13 (Post-Intervention)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Miami Miller School of Medicine - Don Soffer Clinical Research Building — Miami

Идентификаторы

NCT: NCT07356167 · 20250973

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗