Clinical trial NCT05702528: A Wearable Nerve Stimulator for Chronic Migraine/Headache and Mood Disturbance in Adolescents
Official title: A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated Chronic Migraine/Headache and Mood Disturbance in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine in Adolescence
Headache
Mood Disturbance
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Prisma Health-Midlands
First posted: 2023-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will use a waitlist design.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in headache burden
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in headache characteristics
timeFrame: baseline and after 12 weeks of device use
measure: Changes in executive function
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in depressive symptoms
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in anxiety symptoms
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in fatigue
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in sleep disturbance
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in pain
timeFrame: baseline and weeks 4, 8, 12
measure: Changes in concussion symptoms
timeFrame: baseline and weeks 4, 8, 12
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prisma Health Pediatric Neurology
state: South Carolina
Study officials:
References: