A Double-Blind, Randomized Study of Clinical Efficacy of Hypothermic Therapy Following Concussion in Adolescent Athletes as Compared to a Sham-Controlled Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- SCAT-5 change from baseline to the post-72 hour follow-up visit measurement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Sham Pro2Cool with standard of care
The control arm will receive standard of care like the treatment group, along with 30 minutes of sham Pro2Cool® placement in the clinic while being monitored for side effects. The Pro2Cool® device will not be used to provide neck cooling; a 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).
干预措施: Sham Cooling Garment Device (Device)
Pro2Cool intervention with standard of care
The treatment arm will receive standard of care for concussion along with 30 minutes of headneck cooling in the clinic while being monitored for side effects. The Pro2Cool® will be used to provide head and neck cooling.
干预措施: Pro2Cool Device (Device)
结局指标
主要结局
SCAT-5 change from baseline to the post-72 hour follow-up visit measurement
时间窗: Baseline to 72-hour follow-up
Sport Concussion Assessment Tool 5th edition (SCAT-5) is the current standard of practice assessment tool used at the time of injury to diagnose an mTBI.
次要结局
未报告次要终点