Digital Care Program for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a digital care program in reducing migraines. It involves a wearable neuromodulation device called Enso, personalized exercise therapy, and support from a care team. The study targets individuals who have experienced migraines (with or without aura) for at least a year and have at least four migraine days per month. Participants must be able to use a smartphone app and continue their usual migraine medications.
As an unphased trial, this study provides a unique opportunity to explore innovative migraine management strategies.
Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current medications. You need to stay on your current preventive and as-needed medications and not start any new treatments during the trial.
What prior data suggests that the Enso Neuromodulation Wearable Device is safe for migraine management?
Research has shown that the Enso Neuromodulation Wearable Device is generally safe for treating migraines. This device uses transcutaneous electrical nerve stimulation (TENS), a technique with minimal risks. Some users might experience slight skin irritation or discomfort from wearing the device and the electrical pulses, but serious side effects are rare.
The FDA has cleared the Enso device, indicating it meets the safety standards set by the Food and Drug Administration. This approval strongly supports its safety. Additionally, similar non-invasive devices, like Enso, are well-tolerated by most people who use them for migraine relief.12345Why are researchers excited about this trial?
Researchers are excited about the Enso Neuromodulation Wearable Device for migraine because it offers a non-drug approach to treating acute migraine attacks. Unlike standard treatments like triptans or NSAIDs, which involve medication, this device uses neuromodulation to provide relief. Neuromodulation involves delivering gentle electrical pulses to modulate nerve activity, potentially reducing pain without the side effects associated with pills. Additionally, the integration of this device with a digital care program via the Hinge Health app allows for personalized management, making it a promising option for those seeking a more holistic and tech-driven approach to migraine care.
What evidence suggests that the Enso Neuromodulation Wearable Device is effective for reducing migraine frequency?
Research has shown that the Enso Neuromodulation Wearable Device, used by participants in this trial, effectively treats migraines. Specifically, studies found that 56% of users experienced a reduction in pain from moderate or severe to mild after using the device. This wearable eases migraine pain by targeting the trigeminal nerve with gentle electrical signals. Users have found it safe and well-tolerated, reporting lasting relief without needing to increase the treatment's strength. Overall, the Enso device, combined with digital support, offers a promising approach to managing migraines.12456
Who Is on the Research Team?
Jeffrey Krauss, MD
Principal Investigator
Hinge Health, Inc
Are You a Good Fit for This Trial?
This trial is for adults who have either episodic or chronic migraines. Participants should be willing to use a wearable device and take part in a digital care program. People with other serious health issues or conditions that could interfere with the study may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Baseline Run-in
Participants complete a 28-day electronic diary (eDiary) to establish baseline migraine frequency
Intervention
Participants receive full access to the digital care program, including the neuromodulation wearable device and guided exercise therapy
Follow-up
Participants are monitored for safety and effectiveness after the intervention phase
What Are the Treatments Tested in This Trial?
Interventions
- Enso Neuromodulation Wearable Device
Trial Overview
The study tests the Enso for Migraine program, which includes an FDA-cleared neuromodulation wearable device, personalized exercise therapy, and support from a care team. The goal is to see if this approach can reduce how often people get migraines.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1) and, if eligible, receive 12 weeks of access to the digital care program (weeks 1-12). Participants continue daily eDiary throughout the intervention phase. The program combines the FDA-cleared neuromodulation wearable device for acute migraine treatment with a digital care program delivered via the Hinge Health app.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hinge Health, Inc
Lead Sponsor
Citations
Evaluation of a Wearable Device for Acute Treatment ...
The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the head and neck to relieve ...
A Comprehensive Digital Care Program for Migraine ...
This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an ...
Update on Neuromodulation for Migraine and Other Primary ...
Non-invasive neuromodulation devices remain a safe, well-tolerated, and effective therapy for patients with primarily migraine and trigeminal autonomic ...
4.
app.trialscreen.org
app.trialscreen.org/trials/evaluation-wearable-device-acute-treatment-migraines-trial-nct07015125Wearable Device for Acute Migraine Treatment
Study Goals. This study aims to determine the effectiveness of a new wearable device that uses electrical nerve stimulation to reduce migraine pain intensity ...
5.
linkedin.com
linkedin.com/posts/jonfortt_hinge-health-ceo-daniel-perez-told-me-the-activity-7455363648673189888-dn_QHinge Health Launches Migraine Care Program with Enso ...
... Enso wearable, now indicated for migraine via trigeminal-nerve neuromodulation. In trials, 56% of users dropped from moderate/severe pain to ...
6.
hingehealth.com
hingehealth.com/resources/press-releases/hinge-health-launches-comprehensive-migraine-care-program/Hinge Health launches comprehensive Migraine Care ...
Hinge Health's FDA-cleared Enso, a specialized wearable device designed for pain relief, now reduces migraine pain in minutes. Personalized ...
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