NCT05702528

A Wearable Nerve Stimulator for Chronic Migraine/Headache and Mood Disturbance in Adolescents

A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated Chronic Migraine/Headache and Mood Disturbance in Adolescents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Migraine in Adolescence
• Headache
• Mood Disturbance

Interventions

Type	Name	Description
DEVICE	Apollo Neuro	The group will complete daily use of the Apollo Neuro, a wrist-worn consumer wellness device

Timeline

• Start date: 2022-12-08
• Primary completion: 2024-10-02
• Completion: 2024-10-02
• First posted: 2023-01-27
• Last updated: 2023-01-27

Locations

1 site across 1 country: United States