Clinical Trials Logo
  1. Home
  2. Headache
  3. NCT05702528

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

Headache Clinical Trial

Official title:
A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated Chronic Migraine/Headache and Mood Disturbance in Adolescents

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05702528
Study type Interventional
Source University of South Carolina
Contact R. Davis Moore, PhD
Phone 803-777-3278
Email moorerd3@mailbox.sc.edu
Status Recruiting
Phase N/A
Start date December 8, 2022
Completion date October 2, 2024
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT03472872 - A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache Phase 4
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Withdrawn NCT02866084 - Neuromodulation Treatment of Vestibular Migraines N/A
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Not yet recruiting NCT04352218 - Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache Phase 2
Completed NCT02734992 - Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers N/A
Completed NCT01327118 - Prostaglandin F2alpha in a Human Headache Model N/A
Completed NCT01153789 - Study of Oculomotor Dysfunction Leading to Children Vertigo N/A
Not yet recruiting NCT00969995 - Identification of Inflammatory Markers in Migraine Patients N/A
Not yet recruiting NCT00752921 - Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache Phase 4
Completed NCT00212810 - Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache. Phase 4
Terminated NCT00291395 - PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers Phase 1
Completed NCT00263094 - An End to the Yom Kippur (and Ramadan) Headache N/A
Completed NCT00135122 - Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache Phase 3
Completed NCT02475005 - An Intervention to Improve Adolescent Headache Self-management N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Completed NCT01664585 - Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life N/A
Completed NCT04632420 - Evaluation of Headache and Childbirth in a Chronic Pain Population
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease