Migraine in AdolescenceNCT05702528
A Wearable Nerve Stimulator for Chronic Migraine/Headache and Mood Disturbance in Adolescents
A study testing Apollo Neuro in people with Migraine in Adolescence and Headache, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Migraine in Adolescence, Headache, Mood Disturbance
- What is being tested?
- Apollo Neuro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of chronic headache/migraine
- The ability to follow simple instruction
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Prisma Health Pediatric Neurology
Columbia, South Carolina, 29203
Jacob Kay, PhD, 803-434-8885, jacob.kay@prismahealth.org
About this study
Official title: A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated Chronic Migraine/Headache and Mood Disturbance in Adolescents
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.
Read the 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.
- Conditions
- Migraine in Adolescence, Headache, Mood Disturbance
- Being tested
- Apollo Neuro
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo NeuroDevice
The group will complete daily use of the Apollo Neuro, a wrist-worn consumer wellness device
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | The group will begin using the Apollo Neuro device immediately upon entering the study Receives: Device: Apollo Neuro |
| Waitlist treatment | No intervention | The group will be assigned to a waitlist and begin using the Apollo Neuro device twelve weeks after entering the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and weeks 4, 8, 12
Changes in headache characteristics
Proportion of patients who report a change in headache type assessed via chart review
Measured: baseline and after 12 weeks of device use
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.
Measured: baseline and weeks 4, 8, 12
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.
Measured: baseline and weeks 4, 8, 12
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.
Measured: baseline and weeks 4, 8, 12
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.
Measured: baseline and weeks 4, 8, 12
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.
Measured: baseline and weeks 4, 8, 12
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.
Measured: baseline and weeks 4, 8, 12
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.
Measured: baseline and weeks 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start8 Dec 2022
- Primary completion2 Oct 2024 (estimated)
- Study completion2 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a waitlist design.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Midlands
- Responsible party
- Principal investigator, Robert Davis Moore, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702528
- Sponsor's protocol ID
- 1933744
- Status last verified
- Jan 2023
- First submitted
- 14 Dec 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated Chronic Migraine/Headache and Mood Disturbance in Adolescents
- ClinicalTrials.gov ID
- NCT05702528
- Acronym / sponsor ID
- 1933744
- Conditions
- Migraine in Adolescence, Headache, Mood Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Prisma Health-Midlands
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 2 Oct 2024 (estimated)
- Study completion
- 2 Oct 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will use a waitlist design.
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Device: Apollo NeuroThe group will begin using the Apollo Neuro device immediately upon entering the study |
| Waitlist treatment | No intervention | –The group will be assigned to a waitlist and begin using the Apollo Neuro device twelve weeks after entering the study |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of chronic headache/migraine
- The ability to follow simple instruction
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo NeuroThe group will complete daily use of the Apollo Neuro, a wrist-worn consumer wellness device | Device | Immediate treatment |
Primary outcome
Changes in headache burden
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and after 12 weeks of device use
Proportion of patients who report a change in headache type assessed via chart review
Changes in executive function
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and weeks 4, 8, 12
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
Time frame: baseline and weeks 4, 8, 12
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Neuro in people with Migraine in Adolescence and Headache, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R. Davis Moore, PhD (803-777-3278, moorerd3@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in headache burden (time frame: baseline and weeks 4, 8, 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.