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

NCT05702528 | Unknown

• 1 other identifier: 1933744
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Immediate treatment

EXPERIMENTAL

The group will begin using the Apollo Neuro device immediately upon entering the study

Device: Apollo Neuro

Waitlist treatment

NO INTERVENTION

The group will be assigned to a waitlist and begin using the Apollo Neuro device twelve weeks after entering the study

Interventions

Apollo Neuro DEVICE

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

Immediate treatment

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (1)

Prisma Health Pediatric Neurology

Columbia, South Carolina, 29203, United States

RECRUITING

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

R. Davis Moore, PhD

CONTACT

803-777-3278; moorerd3@mailbox.sc.edu

Jacob Kay, PhD

CONTACT

803-434-888; jacob.kay@prismahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will use a waitlist design.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 27, 2023
• Study Start: December 8, 2022
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)