RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-12-08
Study Completion:2024-10-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05702528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A diagnosis of chronic headache/migraine
  2. * The ability to follow simple instruction
  1. * Previous diagnosis of moderate or severe traumatic brain injury
  2. * History of mild traumatic brain injury/concussion within the last six months
  3. * History of schizophrenia or bipolar disorder
  4. * History of epilepsy, cerebral palsy, or severe sensory disorders
  5. * History of stroke or neurodegenerative conditions

Contacts and Locations

Study Contact

R. Davis Moore, PhD
CONTACT
803-777-3278
moorerd3@mailbox.sc.edu
Jacob Kay, PhD
CONTACT
803-434-888
jacob.kay@prismahealth.org

Study Locations (Sites)

Prisma Health Pediatric Neurology
Columbia, South Carolina, 29203
United States

Collaborators and Investigators

Sponsor: University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-08
Study Completion Date2024-10-02

Study Record Updates

Study Start Date2022-12-08
Study Completion Date2024-10-02

Terms related to this study

Additional Relevant MeSH Terms

  • Migraine in Adolescence
  • Headache
  • Mood Disturbance