A Prospective, Single Arm, Open Label Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of New Daily Headache Persistence (NDHP) in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain relief at 2 hours post-treatment
研究概览
简要总结
The goal of this study is to examine the effects of the Remote Electrical Neuromodulation (REN) device on adolescents ages 12-17 who have been diagnosed with New Daily Persistent Headache (NDPH). Pediatric patients with a diagnosis of new daily persistent headache are typically resistant to standard pharmacologic treatments and often experience systemic side effects related to medications; thus, REN offers the potential for an exciting new treatment option for patients with refractory headache disorders. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. Ultimately, the investigators hope to gain insights into the safety and efficacy of Nerivio™ for the acute treatment of NDPH in adolescents. The goal of this study is to demonstrate headache relief without unexpected device-related adverse effects
详细描述
This is a research study to evaluate a new non-invasive drug-free acute treatment of headache in adolescents aged 12-17 years old. Participants are being asked to take part in this study because they suffer from persistent headaches.
Device description:
The device is a wireless wearable battery-operated stimulation unit controlled by a dedicated smartphone application. Treatments with Nerivio™ are self-administered by the user at the onset of a headache. The Nerivio™ includes several main components:
- A pair of electrodes covered with hydrogel and a removeable protective film
- An electronic circuitry and a battery
- A software that includes firmware and a software application for mobile platforms
- An armband to secure the attachment of the device and enable a discreet treatment
Procedures and duration of participation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants age 12-17 years old at the time of informed consent, inclusive.
- •Participants have at least a 6-month history of headaches that meet the diagnostic criteria for New Daily Persistent Headache (NDPH)
- •Participants who are on stable dosing of prophylaxis agents for at least three months.
- •Participants have personal access to a smartphone (24/7)
- •Participants must be able and willing to comply with the protocol
- •Parents/Guardians must be able and willing to provide written informed consent
- •Participants must be able and willing to provide informed assent
排除标准
- •Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- •Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- •Participants with epilepsy.
- •Participants who have undergone nerve block (occipital or other) in the head or neck, or treatment with onabotulinum toxin A (Botox) to the head and/or neck in the prior four months.
- •Current participation in any other clinical interventional study
- •Participants without basic cognitive and motor skills required for operating a smartphone.
- •Pregnant or breastfeeding females
- •Participants who have previous experience with the device
- •Participants with arm circumference below 7.9 inches (20 cm)
结局指标
主要结局
Pain relief at 2 hours post-treatment
时间窗: 2 hours post-treatment
The proportion of participants achieving pain relief at 2 hours post-treatment in the test treatment, with no use of rescue/abortive medication (Pain relief defined as a change from severe to moderate, mild or none, moderate to mild or none, or mild to none)
Within-patient consistency
时间窗: Before and at 1 Month after initiation of treatment with REN
The repeatability of headache change, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks
Disappearance of associated symptoms at 2 hours post-treatment
时间窗: 2 hours post-treatment
Disappearance of nausea, photophobia and phonophobia at 2 hours post- treatment
Functional disability at 2 hours post-treatment
时间窗: 2 hours post-treatment
The proportion of participants achieving a change of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication
Improve of quality of life assessed by PedsMIDAS questionnaire
时间窗: Before and at 1 Month after initiation of treatment with REN
Change in average headache disability as measured by PedsMIDAS before and at 1 month after initiation of treatment with REN.
次要结局
未报告次要终点
研究者
Marc DiSabella
Principal Investigator
Children's National Research Institute