Nerivio Device for New Daily Persistent Headache
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's National Research Institute
Must be taking: Prophylaxis agents
Disqualifiers: Epilepsy, Congestive heart failure, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a wearable device that sends mild electrical pulses to help reduce headache pain in adolescents aged 12-17 with persistent headaches. The device is controlled by a smartphone app and works by triggering the brain's natural pain relief mechanisms. Data from several trials suggest that a device applying gentle electrical pulses can reduce headache pain.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of any preventive medications for at least three months before joining the study.
What data supports the effectiveness of the Nerivio treatment for New Daily Persistent Headache?
Nerivio, a wearable device using remote electrical neuromodulation, has been shown to be effective and safe for treating migraines, as supported by multiple clinical trials and real-world studies. While specific data for New Daily Persistent Headache is not available, its success in treating migraines suggests potential effectiveness for similar headache conditions.
12345Is the Nerivio device safe for use in humans?
The Nerivio device has been shown to be safe for treating migraines, with studies reporting a high safety profile and very few mild adverse events. In a real-world analysis, only 0.48% of users reported any device-related adverse events, and none were severe.
12356How is the Nerivio treatment different from other treatments for new daily persistent headache?
Nerivio is unique because it is a wearable device that uses remote electrical neuromodulation (stimulation of nerves) to treat headaches, unlike traditional medications that are taken orally or injected. This non-invasive approach offers an alternative for those who prefer not to use drugs or have not found relief with standard treatments.
7891011Eligibility Criteria
This trial is for adolescents aged 12-17 with New Daily Persistent Headache (NDPH) who haven't responded well to standard treatments. They must have had NDPH for at least six months, be on stable headache prevention medication for three months, and can operate a smartphone. It's not open to those with implanted devices like pacemakers, severe heart conditions, epilepsy, recent nerve blocks or Botox in the head/neck area, current participation in other trials, cognitive/motor issues affecting smartphone use, pregnancy/breastfeeding status or an arm circumference below 7.9 inches.Inclusion Criteria
Parents/Guardians must be able and willing to provide written informed consent
I am willing and able to agree to participate in the study.
I have been on a stable dose of preventive medication for at least three months.
+6 more
Exclusion Criteria
Current participation in any other clinical interventional study
I have epilepsy.
I have severe heart or brain blood vessel disease.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (in-person)
Run-in
Participants complete a headache diary whenever they experience a new headache
4 weeks
1 visit (in-person)
Device Training
Participants receive the device and are trained on its use and intensity adjustment
1 week
1 visit (in-person)
Treatment
Participants use the device for headache treatment and report feedback through the app
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The Nerivio device is being tested as a new treatment option for adolescent patients with NDPH. This non-drug therapy uses Remote Electrical Neuromodulation (REN) delivered through the upper arm to help relieve headaches by activating natural pain suppression pathways in the brain.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Participants will receive a device and will be asked to treat headaches with it and report in the app the characteristics of the attacks at the beginning of the attack as well as at 2 hours after the treatment.
Nerivio is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Nerivio for:
- Migraine treatment and prevention
🇺🇸 Approved in United States as Nerivio for:
- Acute and preventive treatment of migraine with or without aura in individuals 8 years and older
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's National Medical CenterWashington, United States
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Who Is Running the Clinical Trial?
Children's National Research InstituteLead Sponsor
TheranicaIndustry Sponsor
References
Nerivio® remote electrical neuromodulation for acute treatment of chronic migraine. [2022]Nerivio® (by Theranica Bio-Electronics Ltd, Tel Aviv, Israel) is a wireless, wearable, noninvasive, battery-operated, remote electrical neuromodulation device controlled by a smartphone application. It is US FDA authorized for the acute treatment of migraine with or without aura in people 12 years and older in the US, and European Conformity (CE) marked for the same indication in the EU. The American Headache Society Consensus Statement recommends Nerivio as a tier 2 treatment for migraines. This review summarizes a series of five independent clinical trials and two real-world evidence studies that established safety, tolerability and efficacy of Nerivio in treating migraine attacks. It further provides up-to-date practical information on device usability. Based on findings of this review, Nerivio offers a safe and effective nonpharmacological alternative for acute treatment in patients with chronic (and nonchronic) migraine.
Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety. [2020]Introduction: Noninvasive neuromodulation devices represent an emerging field in the acute treatment of migraine. High efficacy, favorable safety profile, good tolerability and low cost are important factors for the desired shift to non-pharmacological treatments. This will have the potential to improve the quality of life of people with migraine and reduce the risk for adverse events and medication overuse headache (MOH).Areas covered: Nerivio™ (Theranica Bio-Electronics, Israel) is a novel FDA-cleared remote electrical neuromodulation (REN) device for acute treatment of migraine. This review highlights the mechanism of action of REN and summarizes the clinical data. Nerivio™ has been studied in two randomized trials which provide support for the efficacy and safety of the device. Post-hoc analyses suggest that the efficacy of REN is non-inferior to usual care in general and to acute pharmacological treatments specifically.Expert commentary: Nerivo™ integrates clinically meaningful efficacy with a high safety profile, satisfying a great unmet need in migraine acute care. The unique mechanism of action, in which the electrical stimulation is applied to peripheral nerves in the upper arm, permits the introduction of an innovative device with high efficacy and superior and improved usability aspects compared with acute pharmacological treatments and other approved devices.
Device profile of Nerivio for the acute and preventive treatment of episodic or chronic migraine in patients 12 years and older. [2023]Migraine is a prevalent, inherited and disabling brain disease with multiple symptoms and a variety of treatment options. Nerivio, utilizing remote electrical neuromodulation (REN) a wearable device, offers users good efficacy, tolerability and safety. It is user-friendly, affordable, non-addictive and cleared by the FDA and the European Conformity.
Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">Remote electrical neuromodulation (REN) is a novel acute treatment of migraine. Upper arm peripheral nerves are stimulated to induce conditioned pain modulation (CPM)-an endogenous analgesic mechanism in which conditioning stimulation inhibits pain in remote body regions. The REN device (Nerivio®, Theranica Bio-Electronics LTD., Israel) is FDA-authorized for acute treatment of migraine in adults who do not have chronic migraine. The current study assessed the consistency of response over multiple migraine attacks in people with chronic migraine who are typically characterized with severe pain intensity, high disability, and less robust response to triptans.
Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine. [2022]Introduction: Migraine is a chronic neurological disease that is the primary cause of years lived with disability in people under the age of 50. Remote electrical neuromodulation (REN) is a novel drug-free acute treatment of migraine, that is FDA cleared for episodic and chronic migraine. As a prescribed digital therapeutic, REN enables large-scale post-marketing research, thus providing real-world information on the use of the intervention in a wide range of populations, environments, and situations. Methods: The REN device (®Nerivio) includes a secured, personal migraine diary, which patients can use to record their symptoms before treatment and 2 h post-treatment. Real-world data on REN treatments were collected via the app from patients across the United States who used Nerivio between October 1st, 2019, and May 24th, 2021. Data analysis focused on four metrics: 1. Per-treatment patterns of REN use as a standalone treatment vs. in combination with medications. 2. Per-user intra-individual efficacy across multiple treatments. 3. Distribution of treatment intensity among users (the electroceutical equivalent to treatment dose). 4. Prevalence and severity of adverse events. Results: 1. Out of 23,151 treatments, in 66.5% of treatments REN was used as a standalone treatment, in 12.9% it was followed by over-the-counter medications, and in 20.6% followed by prescription medications. 2. Out of 2,514 patients, response in at least 50% of treatments was achieved in 66.5% of cases for pain relief, and in 22.6% for pain freedom. 3. Out of 117,583 treatments, in 80% of cases intensity levels were between 18 and 55% of the stimulator's range. The mean intensity was 34.3% of the stimulator's output (±16.6%). 4. Out of 12,368 users (121,947 treatments), there were 59 users (0.48%) who reported device related adverse events, 56 (0.45%) of which were mild, three (0.03%) were moderate, and none were severe. Conclusions: The current analysis of real-world clinical data indicates that REN provides an efficacious, stable, and safe treatment option for acute treatment of migraine in real-world settings, both as a standalone replacement of pharmaceuticals, as well as an adjunct to medications.
Using a graphical risk tool to examine willingness to take migraine prophylactic medications. [2022]Many migraine sufferers use daily prophylactic therapy to reduce the frequency of their headache attacks. The Food and Drug Administration has approved several different medications for migraine prophylaxis, but it is not clear whether sufferers perceive these treatments to provide clinically significant benefits given their side effect profiles. Three hundred headache sufferers were recruited from the community and local headache clinics using print and television advertising. Participants reported experiencing problematic headache attacks with a median (IQR) frequency of 7.0 (4-13) headache days per month. These sufferers participated in a cross-sectional, single-site, study that used a specially designed computer assessment task. Participants were instructed on the probability of experiencing the 3 most commonly experienced side effects for several blinded medication profiles: divalproex sodium, venlafaxine, gabapentin, propranolol, and topiramate. After learning the likelihood of experiencing side effect profiles of each medication, participants were asked whether they would be willing to take the medication for a given headache reduction level, which ranged from 0 to 7 days per month. The side effect profile for divalproex sodium was associated with the smallest willingness to take, with gabapentin, propranolol, and topiramate perceived to be much more agreeable. However,
[The daily experience of the patient with an implantable cardioverter defibrillator]. [2010]To describe the daily experience of patients with an automatic defibrillator (AD) implant and the adaptive changes of the patient.
Detection of Recurrent Atrial Fibrillation Utilizing Novel Technology. [2022]The true prevalence of AF is likely underestimated because episodes are often sporadic and challenging to detect in a "real world" setting. This case report will describe a 58-year-old atrial fibrillation patient with multiple cardiac risk factors. After two ablations and one cardioversion, the patient failed to remain in normal sinus rhythm. Shortly after AF returned, the decision was made to perform a second cardioversion. Post-procedure, the patient was given a novel FDA-approved, wireless ECG monitoring device compatible with the iPhone®. This device has the capability of recording and transmitting a single-channel ECG. Within days, the patient began feeling symptomatic again and used his device to transmit an ECG to his healthcare provider. Recurrent AF was detected and the patient was directed to seek further evaluation. The success of this novel device to detect recurrent AF highlights the "real world" applicability of using mHealth technology more readily in patient care.
New generations of implantable pacemaker defibrillators for ventricular and atrial tachyarrhythmias. [2009]Implantable defibrillation devices have now been extensively applied to patients requiring cardioversion and defibrillation of sustained ventricular tachyarrhythmias. The focus of new developments is in improving technology, achieving physiologic operation in the atrium and ventricle, seeking new indications and identifying patient populations amenable to this therapy. Ventricular application technology is focusing on simplifying and improving robustness of lead systems yet seeking lower defibrillation thresholds. Dual chamber pacing, sensing and defibrillation are being developed. New populations for ventricular application include non-sustained ventricular tachycardia patients with coronary artery disease, dilated cardiomyopathy at risk for sudden death, long QT syndrome, pediatric patients with risk of sudden death and high risk postoperative coronary bypass patients. New applications include atrial defibrillation combined with atrial pacing in future devices. These devices are planned to have capabilities of ventricular defibrillation as a backup to address proarrhythmia concerns. It can be anticipated that implantable cardioverter defibrillator devices will be used for arrhythmia reversion in an expanding group of patients in the future.
Application-Based Early Interventions of Hardware-Related Infection After Invasive Neuromodulation Prevent Implant Removal. [2022]This study aimed to establish a mobile health application to diagnose and treat postdischarge hardware-related infections in a timely manner and prevent the complete removal of hardware or an implantable pulse generator (IPG).
Description and evaluation of the Res-Q Arrhythmia Control Device. [2019]The Res-Q Arrhythmia Control Device (Intermedics Inc.) is one of the latest entries into the growing implantable cardioverter defibrillator (ICD) market. Dysrhythmias are classified according to their zone of detection, with a bradycardia zone, up to 3 tachycardia zones, and a fibrillation zone. Detection criterion, therapies, and redetection criterion within each zone are independently programmable, tailoring the setup to each individual's needs. In a hierarchical manner, this allows efficacy, urgency, and patient comfort to be appropriately balanced. Tachycardia therapy options include antitachycardia pacing (ATP), low-energy cardioversion, and high-energy shock, while VVI pacing provides bradycardia therapy. ATP programming is extremely flexible. Biphasic waveform and a maximum output of 700 V have yielded a high rate of successful implantation. Unique features include the multiprogrammable sensing autogain, which tracks evoked T waves during pacing, as well as the use of the pulse generator to perform implant testing. Major strengths include programming flexibility and individualized therapy for multiple dysrhythmias. The major shortcoming relates to a lack of stored electrograms. Although long-term follow-up is not yet available, the Res-Q appears to be a capable challenger to a peer group of advanced generation ICDs.