Pro-2-Cool Pivotal Trial II

Официальное название

A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population

Обзор

This study is being conducted to determine the clinical safety and efficacy of Pro-2-Cool mediated head and neck cooling when applied after concussion and improved symptomatology among adolescent athletes as quantified by post-concussion symptom severity (PCSS) score.

Подробное описание

This is a multi-center, prospective, randomized, double-blinded, dual-arm comparative study enrolling up to a total of 66 patients (approximately 33 patients in the treatment arm and 33 patients in the control arm) following sports-related, concussion.

Вмешательства

• Устройство Pro2Cool Device
  The Pro2Cool Device is a non-invasive hypothermic therapy ("cold therapy") device that provides localized cooling of the head and neck. Water and isopropyl alcohol cooled to 6°C by the chiller assembly circulate through the cooling garment to create conductive heat transfer from the scalp and carotid arteries, thus achieving cooling of the brain.
• Устройство Sham Cooling Garment Device
  The sham cooling garment device will be placed with impaired cooling function (only to the head), with sham treatment temperature being set to 19°C (instead of the therapeutic 6°C specification). There will be no thermal nylon barrier that will be used and flow to the neck bladder will be closed.

Первичные конечные точки

• Change quantified by post-concussion symptom severity (PCSS) assessment score [Срок оценки: Post-injury to 72-hour follow-up]

Вторичные конечные точки (1)

• Number of adverse events associated with the head-and-neck cooling treatment [Срок оценки: Treatment to 72-hour follow-up]

Критерии участия

Критерии включения

• Males and females, 13-21 years of age
• Confirmed concussion diagnosis consistent with American Congress Rehabilitation Medicine guidelines 21, without any of the following:

• Glasgow Coma Scale (GCS) score of less than 13 at 30 minutes post-injury
• Loss of consciousness greater than 30 minutes
• Post-traumatic amnesia lasting over 24 hours
• Glasgow Coma Scale (GCS) ≥ 13 at the time of initial injury for study enrollment.
• Post-Concussion Symptom Scale Score minimum of 15
• Initial provider visit is within 7 days of injury
• In generally good health as confirmed by medical history and determined by site investigator or designated trained healthcare professional under the supervision of the principal investigator.
• Has informed consent obtained per protocol and as required per Institutional Review Board

Критерии исключения

• Age < 13 years or > 21 years
• Inability to understand the study requirements or provide informed consent
• Cleared to return to play during initial visit
• Prior participation in a Pro2Cool Clinical Study
• Serious traumatic brain injury as evidenced by worsening symptoms:

• Vomiting > 2 episodes following injury
• Seizure
• Hospitalization
• Radiology scan indicating brain bleed
• Slurred speech which has not resolved within 72 hours of concussive injury
• Physical (e.g., head or neck injury that requires medical treatment) or mental disability hindering adequate response to assessment of symptoms
• Hemodynamic instability/medical condition requiring further acute life-saving medical intervention
• History of psychiatric disorder that includes suicide attempts within the last 6 months, unmanaged depression or anxiety, hospitalization for psychiatric treatment within the last 6 months
• Known brain mass, intracranial hemorrhage, skull fracture
• Scalp abnormalities including laceration or bleeding
• Presence of ventriculoperitoneal (VP) shunt
• Known hematological malignancies, including, but not limited to: multiple myeloma, leukemia, and lymphoma
• Known history of Reynaud's Disease compromised liver function, cold agglutination, cold sensitivity, cryoglobulinemia, cryofibrinogenemia, and/or a history of severe migraines
• Known or disclosed pregnancy or breast-feeding
• Sustains another head or neck injury at the time of concussive injury which requires medical treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Michigan — Ann Arbor
• Akron Children's Hospital — Akron
• Cleveland Clinic Foundation — Cleveland

Идентификаторы

NCT: NCT06929923 · 1380718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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