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

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.

Study Overview

• Status: Recruiting
• Conditions: Headache; Mood Disturbance; Migraine in Adolescence
• Intervention / Treatment: Device: Apollo Neuro

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: R. Davis Moore, PhD; Phone Number: 803-777-3278; Email: moorerd3@mailbox.sc.edu
• Study Contact Backup: Name: Jacob Kay, PhD; Phone Number: 803-434-888; Email: jacob.kay@prismahealth.org

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Recruiting
      • Prisma Health Pediatric Neurology
      • Contact: Jacob Kay, PhD; Phone Number: 803-434-8885; Email: jacob.kay@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A diagnosis of chronic headache/migraine
• The ability to follow simple instruction

Exclusion Criteria:

• Previous diagnosis of moderate or severe traumatic brain injury
• History of mild traumatic brain injury/concussion within the last six months
• History of schizophrenia or bipolar disorder
• History of epilepsy, cerebral palsy, or severe sensory disorders
• History of stroke or neurodegenerative conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate treatment; The group will begin using the Apollo Neuro device immediately upon entering the study	Device: Apollo Neuro; The group will complete daily use of the Apollo Neuro, a wrist-worn consumer wellness device
No Intervention: Waitlist treatment; The group will be assigned to a waitlist and begin using the Apollo Neuro device twelve weeks after entering the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in headache burden	Index of headache-related burden using the Headache Impact Test-6. Scores range from 36 to 78 with higher scores indicating worse outcomes.	baseline and weeks 4, 8, 12
Changes in headache characteristics	Proportion of patients who report a change in headache type assessed via chart review	baseline and after 12 weeks of device use
Changes in executive function	Parent-reported executive function will be measured with the Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF includes t-scores for comparison to sex- and age-normed data, with higher values indicating worse outcomes.	baseline and weeks 4, 8, 12
Changes in depressive symptoms	Index of depressive symptoms using the Beck Youth Inventory Depression scale. Raw scores range from 0 to 60, with higher scores indicating more depressive symptoms. T-scores are also included for comparison to normative data.	baseline and weeks 4, 8, 12
Changes in anxiety symptoms	Index of anxiety symptoms using the Beck Youth Inventory Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more anxiety symptoms. T-scores are also included for comparison to normative data.	baseline and weeks 4, 8, 12
Changes in fatigue	Index of fatigue using the Neurological Quality of Life (Neuro-QoL) fatigue sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse fatigue. T-scores are also included for comparison to normative data.	baseline and weeks 4, 8, 12
Changes in sleep disturbance	Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse sleep disturbance. T-scores are also included for comparison to normative data.	baseline and weeks 4, 8, 12
Changes in pain	Index of pain using the Neurological Quality of Life (Neuro-QoL) pain sub-scale. Raw scores range from 0 to 40, with higher scores indicating worse pain. T-scores are also included for comparison to normative data.	baseline and weeks 4, 8, 12
Changes in concussion symptoms	Index of symptoms related to concussion using the Sport Concussion Assessment Tool-5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 concussion symptoms, each rated on a scale from 0 to 6 with higher scores indicating more severe symptoms.	baseline and weeks 4, 8, 12

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Prisma Health-Midlands

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Anticipated): October 2, 2024
• Study Completion (Anticipated): October 2, 2024

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: 1933744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No