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

Primary Purpose

Migraine in Adolescence, Headache, Mood Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apollo Neuro
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine in Adolescence

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prisma Health Pediatric NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate treatment

Waitlist treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in headache burden
Index of headache-related burden using the Headache Impact Test-6. Scores range from 36 to 78 with higher scores indicating worse outcomes.
Changes in headache characteristics
Proportion of patients who report a change in headache type assessed via chart review
Changes in executive function
Parent-reported executive function will be measured with the Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF includes t-scores for comparison to sex- and age-normed data, with higher values indicating worse outcomes.
Changes in depressive symptoms
Index of depressive symptoms using the Beck Youth Inventory Depression scale. Raw scores range from 0 to 60, with higher scores indicating more depressive symptoms. T-scores are also included for comparison to normative data.
Changes in anxiety symptoms
Index of anxiety symptoms using the Beck Youth Inventory Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more anxiety symptoms. T-scores are also included for comparison to normative data.
Changes in fatigue
Index of fatigue using the Neurological Quality of Life (Neuro-QoL) fatigue sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse fatigue. T-scores are also included for comparison to normative data.
Changes in sleep disturbance
Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse sleep disturbance. T-scores are also included for comparison to normative data.
Changes in pain
Index of pain using the Neurological Quality of Life (Neuro-QoL) pain sub-scale. Raw scores range from 0 to 40, with higher scores indicating worse pain. T-scores are also included for comparison to normative data.
Changes in concussion symptoms
Index of symptoms related to concussion using the Sport Concussion Assessment Tool-5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 concussion symptoms, each rated on a scale from 0 to 6 with higher scores indicating more severe symptoms.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
January 25, 2023
Sponsor
University of South Carolina
Collaborators
Prisma Health-Midlands
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1. Study Identification

Unique Protocol Identification Number
NCT05702528
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
October 2, 2024 (Anticipated)
Study Completion Date
October 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Prisma Health-Midlands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine in Adolescence, Headache, Mood Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will use a waitlist design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate treatment
Arm Type
Experimental
Arm Description
The group will begin using the Apollo Neuro device immediately upon entering the study
Arm Title
Waitlist treatment
Arm Type
No Intervention
Arm Description
The group will be assigned to a waitlist and begin using the Apollo Neuro device twelve weeks after entering the study
Intervention Type
Device
Intervention Name(s)
Apollo Neuro
Intervention Description
The group will complete daily use of the Apollo Neuro, a wrist-worn consumer wellness device
Primary Outcome Measure Information:
Title
Changes in headache burden
Description
Index of headache-related burden using the Headache Impact Test-6. Scores range from 36 to 78 with higher scores indicating worse outcomes.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in headache characteristics
Description
Proportion of patients who report a change in headache type assessed via chart review
Time Frame
baseline and after 12 weeks of device use
Title
Changes in executive function
Description
Parent-reported executive function will be measured with the Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF includes t-scores for comparison to sex- and age-normed data, with higher values indicating worse outcomes.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in depressive symptoms
Description
Index of depressive symptoms using the Beck Youth Inventory Depression scale. Raw scores range from 0 to 60, with higher scores indicating more depressive symptoms. T-scores are also included for comparison to normative data.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in anxiety symptoms
Description
Index of anxiety symptoms using the Beck Youth Inventory Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more anxiety symptoms. T-scores are also included for comparison to normative data.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in fatigue
Description
Index of fatigue using the Neurological Quality of Life (Neuro-QoL) fatigue sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse fatigue. T-scores are also included for comparison to normative data.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in sleep disturbance
Description
Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep sub-scale. Raw scores range from 0 to 32, with higher scores indicating worse sleep disturbance. T-scores are also included for comparison to normative data.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in pain
Description
Index of pain using the Neurological Quality of Life (Neuro-QoL) pain sub-scale. Raw scores range from 0 to 40, with higher scores indicating worse pain. T-scores are also included for comparison to normative data.
Time Frame
baseline and weeks 4, 8, 12
Title
Changes in concussion symptoms
Description
Index of symptoms related to concussion using the Sport Concussion Assessment Tool-5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 concussion symptoms, each rated on a scale from 0 to 6 with higher scores indicating more severe symptoms.
Time Frame
baseline and weeks 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R. Davis Moore, PhD
Phone
803-777-3278
Email
moorerd3@mailbox.sc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Kay, PhD
Phone
803-434-888
Email
jacob.kay@prismahealth.org
Facility Information:
Facility Name
Prisma Health Pediatric Neurology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Kay, PhD
Phone
803-434-8885
Email
jacob.kay@prismahealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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