A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated Chronic Migraine/Headache and Mood Disturbance in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in headache burden
研究概览
简要总结
The aim of this clinical trial is to test a wrist-worn nerve stimulator in adolescents with chronic migraine/headache and mood disturbance. The main question it aims to answer is whether this device is effective in relieving clinical symptoms including pain, anxiety, depression and sleep disturbance.
Participants will wear the device for twelve weeks and complete monthly surveys throughout the study.
详细描述
The aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical and physical symptoms of adolescents struggling with chronic migraine/headache with overlapping mood disturbance. This device is worn on the wrist and produces silent, low-frequency waves that feel like slight vibrations. An Apollo Neuro Device will be offered as part of a treatment plan to patients with chronic neurological symptoms. Patients will be placed in either a treatment or waitlist treatment group randomly. Those in the treatment group will immediately use the Apollo Neuro Device for twelve weeks and those in the waitlist group will follow the standard plan of care for twelve weeks. At twelve weeks the initial treatment group will conclude their time in the study and the waitlist group will begin use of the device for another twelve weeks. Patients will complete surveys when they are given the Apollo Neuro Device, monthly while using the device, and after twelve weeks of use. The waitlist group will also complete surveys upon enrolling in the study and monthly thereafter until the completion of their intervention. The findings of this study will further the understanding of autonomic dysfunction symptomology and recovery in the diagnosis of adolescent chronic headache/migraine and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction and reducing symptoms in these patients.
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
- 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
- •A diagnosis of chronic headache/migraine
- •The ability to follow simple instruction
排除标准
- •Previous diagnosis of moderate or severe traumatic brain injury
- •History of mild traumatic brain injury/concussion within the last six months
- •History of schizophrenia or bipolar disorder
- •History of epilepsy, cerebral palsy, or severe sensory disorders
- •History of stroke or neurodegenerative conditions
结局指标
主要结局
Changes in headache burden
时间窗: baseline and weeks 4, 8, 12
Index of headache-related burden using the Headache Impact Test-6. Scores range from 36 to 78 with higher scores indicating worse outcomes.
Changes in headache characteristics
时间窗: baseline and after 12 weeks of device use
Proportion of patients who report a change in headache type assessed via chart review
Changes in anxiety symptoms
时间窗: baseline and weeks 4, 8, 12
Index of anxiety symptoms using the Beck Youth Inventory Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more anxiety symptoms. T-scores are also included for comparison to normative data.
Changes in fatigue
时间窗: baseline and weeks 4, 8, 12
Index of fatigue 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 executive function
时间窗: baseline and weeks 4, 8, 12
Parent-reported executive function will be measured 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 sleep disturbance
时间窗: baseline and weeks 4, 8, 12
Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep sub-scale. 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 depressive symptoms
时间窗: baseline and weeks 4, 8, 12
Index of depressive symptoms using the Beck Youth Inventory Depression scale. Raw scores range from 0 to 60, with higher scores indicating more depressive symptoms. T-scores are also included for comparison to normative data.
Changes in pain
时间窗: baseline and weeks 4, 8, 12
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 concussion symptoms
时间窗: baseline and weeks 4, 8, 12
Index of symptoms related to concussion using the Sport Concussion Assessment Tool-5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 concussion symptoms, each rated on a scale from 0 to 6 with higher scores indicating more severe symptoms.
次要结局
未报告次要终点
研究者
Robert Davis Moore
Assistant Professor
University of South Carolina