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

NCT05702528 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-27

No results posted yet for this study

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.

Conditions

  • Migraine in Adolescence
  • Headache
  • Mood Disturbance

Interventions

DEVICE

Apollo Neuro

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

Sponsors & Collaborators

  • Prisma Health-Midlands

    collaborator OTHER
  • University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2024-10-02
Completion
2024-10-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05702528 on ClinicalTrials.gov