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

University of South Carolina

Status: Enrolling

Conditions: Migraine in Adolescence; Headache; Mood Disturbance

Treatments: Device: Apollo Neuro

Study type: Interventional

Funder types: Other

Identifiers

NCT05702528

1933744

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immediate treatment

Experimental group

Description:

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

Treatment:

Device: Apollo Neuro

Waitlist treatment

No Intervention group

Description:

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