Recruiting

Wearable Nerve Stimulator

Sponsor:

University of South Carolina

Code:

NCT05702528

Conditions

Migraine in Adolescence

Headache

Mood Disturbance

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

Apollo Neuro

Study Details

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

Study ID

NCT05702528

Start date

Dec 8, 2022

Status verified date

Jan, 2023

Completion date

Oct 2, 2024

Anticipated

Primary completion date

Oct 2, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate treatment

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

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

Interventions

Apollo Neuro

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

Primary outcome measure

  • Changes in headache burden [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in headache characteristics [ Time Frame: baseline and after 12 weeks of device use ]
  • Changes in executive function [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in depressive symptoms [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in anxiety symptoms [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in fatigue [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in sleep disturbance [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in pain [ Time Frame: baseline and weeks 4, 8, 12 ]
  • Changes in concussion symptoms [ Time Frame: baseline and weeks 4, 8, 12 ]

Central Contacts and Locations

Central contacts

R. Davis Moore, PhD

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

Jacob Kay, PhD

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

Locations

Prisma Health Pediatric Neurology

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Jacob Kay, PhD

803-434-8885jacob.kay@prismahealth.org

More Information

Sponsor

University of South Carolina

Last update posted

Jan 27, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2023-01-27.