A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated With Persistent Post-Concussive Symptoms in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in pain severity
研究概览
简要总结
The goal of this study is to test a wearable nerve stimulator in adolescents with persistent post-concussive symptoms. The main questions it aims to answer is whether the device will reduce clinical symptom burden, reduce cognitive deficits, and aid in the recovery of clinical symptoms.
Participants will wear the device daily for six weeks and complete a series of assessments.
详细描述
The primary aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical symptoms, cognitive deficits and physical symptoms of those patients struggling with persisting post-concussive symptoms. The Apollo Neuro Device offers a convenient novel, non-invasive, non-habit-forming solution to improve performance and recovery under stress by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time. The investigators will carry out a prospective study including any individual over the age of ten years presenting with persisting post-concussive symptoms. An Apollo Neuro Device will be offered as part of a treatment plan to patients with chronic neurological symptoms and will be used as an adjunct along with typical treatment. Patients will follow-up for a comprehensive evaluation, per discretion of specialty physicians and weekly symptom surveys will also be emailed to patients to track status. The results of this study will further the understanding of autonomic dysfunction symptomology and recovery and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •concussion diagnosis
- •able to follow simple instruction
- •able to sit upright in a chair for at least 30 minutes without rest
排除标准
- •previous diagnosis of moderate or severe traumatic brain injury
- •neuropsychiatric conditions of schizophrenia or bipolar disorder
- •neurophysiological conditions of epilepsy, cerebral palsy, or severe sensory disorders
结局指标
主要结局
Changes in pain severity
时间窗: pre-intervention and after three and six weeks of device use
Index of pain using the Neurological Quality of Life (Neuro-QoL) pain sub-scale. Raw scores range from 0 to 40, with higher scores indicating worse pain. T-scores are also included for comparison to normative data.
Changes in vestibular/ocular motor screening
时间窗: pre-intervention and after three and six weeks of device use
Visuomotor processing issues associated with concussion, assessed via the Vestibular/Ocular Motor Screening assessment (VOMS).
Changes in depression symptoms
时间窗: pre-intervention and after three and six weeks of device use
Index of depression symptoms using the Beck Youth Inventory - Depression scale. Raw scores range from 0 to 60, with higher scores indicating more severe symptoms. T-scores are also included for comparison to normative data.
Changes in fatigue
时间窗: pre-intervention and after three and six weeks of device use
Index of pain using the Neurological Quality of Life (Neuro-QoL) fatigue sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse fatigue. T-scores are also included for comparison to normative data.
Changes in balance
时间窗: pre-intervention and after three and six weeks of device use
Neuromuscular control assessed via the Modified Balance Error Scoring Screen (mBESS).
Change in concussion symptoms from pre-injury levels
时间窗: pre-intervention and after three and six weeks of device use
Current severity of concussion symptoms in comparison to severity prior to injury will be assessed with the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). The RPQ includes 16 concussion symptoms that are rated in comparison to pre-injury levels from 0 to 4, with higher scores indicating more severe symptoms.
Changes in anxiety symptoms
时间窗: pre-intervention and after three and six weeks of device use
Intensity of anxiety symptoms assessed with the Beck Youth Inventory - Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more severe symptoms. T-scores are also included for comparison to normative data.
Changes in sleep disturbance
时间窗: pre-intervention and after three and six weeks of device use
Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep subscale. Raw scores range from 0 to 32, with higher scores indicating worse sleep disturbance. T-scores are also included for comparison to normative data.
Changes in cognitive function
时间窗: pre-intervention and after three and six weeks of device use
Performance on the CogState, a validated brain injury cognitive battery.
Changes in executive function
时间窗: pre-intervention and after three and six weeks of device use
Observed functioning will be reported by parents/guardians with the Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF includes t-scores for comparison to sex- and age-normed data, with higher values indicating worse outcomes.
Changes in heart rate variability
时间窗: pre-intervention and after three and six weeks of device use
Cardio-autonomic function recorded at rest and while under increased physiological demand during a hand grip task.
Weekly changes in concussion symptoms
时间窗: pre-intervention and weekly during the intervention
Index of concussion symptoms using the Sport Concussion Assessment Tool 5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 common concussion symptoms, each rated on a scale from 0 (not present) to 6 (severe).
Changes in psycho-affective health
时间窗: pre-intervention and after three and six weeks of device use
Index of psycho-affective health using the Profile of Mood States (POMS). Higher scores on the POMS indicate more intensely experienced mood states.
Changes in headache burden
时间窗: pre-intervention and after three and six weeks of device use
Index of headache-related burden using the Headache Impact Test-6 (HIT-6). Scores range from 36-78 with higher scores indicating worse outcomes.
次要结局
未报告次要终点
研究者
Robert Davis Moore
Assistant Professor
University of South Carolina