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Nerve Stimulator

Wearable Nerve Stimulation for Migraines and Mood Disorders

N/A
Recruiting
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of chronic headache/migraine
A diagnosis of chronic headache/migraine
Must not have
Previous diagnosis of moderate or severe traumatic brain injury
History of stroke or neurodegenerative conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 8, 12
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a wrist-worn nerve stimulator to see if it can reduce pain, anxiety, depression & sleep disruption in adolescents with chronic headaches & mood trouble. Participants wear device & complete monthly surveys for 12 weeks.

Who is the study for?
This trial is for adolescents with chronic migraines or headaches and mood disturbances, who can follow simple instructions. It's not suitable for those with epilepsy, cerebral palsy, severe sensory disorders, stroke, neurodegenerative conditions, recent traumatic brain injury/concussion, schizophrenia or bipolar disorder.
What is being tested?
The study tests a wrist-worn nerve stimulator called Apollo Neuro to see if it helps relieve pain from chronic migraine/headache and improves mood issues like anxiety and depression in adolescents over twelve weeks.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort at the site of wearing the device or skin irritation. Since it's non-invasive stimulation therapy, serious side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic headaches or migraines.
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I have been diagnosed with chronic headaches or migraines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a moderate or severe brain injury in the past.
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I have had a stroke or suffer from a condition that affects my brain function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 8, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 4, 8, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in anxiety symptoms
Changes in concussion symptoms
Changes in depressive symptoms
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate treatmentExperimental Treatment1 Intervention
The group will begin using the Apollo Neuro device immediately upon entering the study
Group II: Waitlist treatmentActive Control1 Intervention
The group will be assigned to a waitlist and begin using the Apollo Neuro device twelve weeks after entering the study

Find a Location

Who is running the clinical trial?

Prisma Health-MidlandsOTHER
23 Previous Clinical Trials
2,735 Total Patients Enrolled
University of South CarolinaLead Sponsor
223 Previous Clinical Trials
120,418 Total Patients Enrolled

Media Library

Apollo Neuro (Nerve Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05702528 — N/A
Headache Research Study Groups: Immediate treatment, Waitlist treatment
Headache Clinical Trial 2023: Apollo Neuro Highlights & Side Effects. Trial Name: NCT05702528 — N/A
Apollo Neuro (Nerve Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05702528 — N/A
~21 spots leftby Dec 2025
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