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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 8, 12
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with chronic headaches or migraines.
Select...
I have been diagnosed with chronic headaches or migraines.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in anxiety symptoms
Changes in concussion symptoms
Changes in depressive symptoms
+6 more

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?

University of South CarolinaLead Sponsor
210 Previous Clinical Trials
120,369 Total Patients Enrolled
Prisma Health-MidlandsOTHER
23 Previous Clinical Trials
2,766 Total Patients Enrolled

Media Library

Apollo Neuro (Nerve Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05702528 — N/A
Migraine Research Study Groups: Immediate treatment, Waitlist treatment
Migraine 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total capacity of this research endeavor?

"Affirmative, information found on clinicaltrials.gov clearly states that recruitment for this medical trial is ongoing. The initial posting date was December 8th 2022 and the latest update was January 25th 2023; 60 volunteers are needed from 1 site to complete it successfully."

Answered by AI

Are investigators still looking for participants in this experiment?

"Affirmative. Clinicaltrials.gov has published information that indicates this medical trial is actively recruiting participants, having been initially posted on December 8th 2022 and updated as recently as January 25th 2023. The study needs 60 individuals to be recruited from 1 centre in particular."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Prisma Health Pediatric Neurology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~17 spots leftby Oct 2024