ACTRN12621001355864已完成未知
Investigating the neural effects of subconcussive head impacts in athletes: A pilot RCT using advanced neuroimaging techniques
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 35 Years（—）
- 性别
- All
入选标准
- •Healthy individuals
- •- More than or equal to 5 years of soccer heading experience; that is, more than or equal to 5 full seasons of play and(or) training (with heading) the most recent of which was completed in the last 2 years.
- •- Proficient in English and able to provide informed consent
排除标准
- •(a)A self-reported head, neck, face and/or eye injury (including concussion; as assessed via the Concussion History Questionnaire in the last 12 months
- •(b)A current, self-reported sports injury (any type)
- •(c)A self-reported history of neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness >15-minutes, spinal cord injury, stroke)
- •(d)Implantation of a cochlear device, cardiac pacemaker, intracardiac lines, medical fusion device, neurostimulator or metal plates (in the head)
- •(e)Use of dental braces or eyeglasses (contact lenses permitted)
- •(f)A contraindication to MRI (that is not already excluded in another criterion) (i.e., body and(or) facial piercings that cannot easily be removed, a drug infusion pump that cannot easily be removed)
- •(g)A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria or at the medical doctor’s discretion, except, mild to moderate depression (score <20 on the Beck Depression Inventory [BDI] or mild to moderate anxiety (score <16 on the Beck Anxiety Inventory [BAI]
- •(h)A history of attempted suicide or current suicide ideation as determined by a score >0 on Question 9 of the Patient Health Questionnaire (PHQ)-9
- •(i)Inability to avoid soccer heading or any other activity involving head impacts (e.g., contact sports) 7-days prior to and while participating in this project
- •(j)Inability to refrain from consuming alcohol (24 hours) and caffeine (12 hours) prior to each experimental trial
- •(k)Inability to refrain from using anti-inflammatory medications (4-days) prior to each experimental trial (e.g., non-steroidal anti-inflammatories [NSAIDs], such as Ibuprofen, Naproxen, Diclofenac; and corticosteroids, such as Prednisolone).
- •(l)Inability to refrain from using central nervous system (CNS) active drugs (i.e., cocaine, cannabis, amphetamines, methamphetamine, benzodiazepines, methadone, opioids, oxycodone, barbiturates) 7-days prior to and while participating in this project as confirmed by a negative urine drug screen (UDS) (DrugCheck® NxStep Onsite Urine Test Cup)
- •(m)Pregnant or lactating. All female volunteers of childbearing potential will be required to complete a urine pregnancy test (Human Chorionic Gonadotrophin [hCG] Cassette, AlereTM). Females of childbearing potential must also agree to use a reliable form of contraception while participating in this project.
- •(n)Current use of platelet active agents such as aspirin, ticagrelor, clopidogrel and prasugrel, warfarin and direct oral anticoagulants (DOACs)
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