Concussion, BrainNCT05685121
A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents
A study testing Apollo Neuro in people with Concussion, Brain, run by University of South Carolina at 1 site in United States.
Trial summary
The goal of this study is to test a wearable nerve stimulator in adolescents with persistent post-concussive symptoms. The main questions it aims to answer is whether the device will reduce clinical symptom burden, reduce cognitive deficits, and aid in the recovery of clinical symptoms. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Concussion, Brain
- 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to Sep 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
- concussion diagnosis
- able to follow simple instruction
- able to sit upright in a chair for at least 30 minutes without rest
Who cannot join
- previous diagnosis of moderate or severe traumatic brain injury
- neuropsychiatric conditions of schizophrenia or bipolar disorder
- neurophysiological conditions of epilepsy, cerebral palsy, or severe sensory disorders
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Prisma Health Pediatric Concussion Clinic
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 With Persistent Post-Concussive Symptoms in Adolescents
The goal of this study is to test a wearable nerve stimulator in adolescents with persistent post-concussive symptoms. The main questions it aims to answer is whether the device will reduce clinical symptom burden, reduce cognitive deficits, and aid in the recovery of clinical symptoms.
Participants will wear the device daily for six weeks and complete a series of assessments.
Read the detailed description
The primary aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical symptoms, cognitive deficits and physical symptoms of those patients struggling with persisting post-concussive symptoms. The Apollo Neuro Device offers a convenient novel, non-invasive, non-habit-forming solution to improve performance and recovery under stress by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time. The investigators will carry out a prospective study including any individual over the age of ten years presenting with persisting post-concussive symptoms. An Apollo Neuro Device will be offered as part of a treatment plan to patients with chronic neurological symptoms and will be used as an adjunct along with typical treatment. Patients will follow-up for a comprehensive evaluation, per discretion of specialty physicians and weekly symptom surveys will also be emailed to patients to track status. The results of this study will further the understanding of autonomic dysfunction symptomology and recovery and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction in these patients.
- Conditions
- Concussion, Brain
- Being tested
- Apollo Neuro
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo NeuroDevice
The device is a wearable nerve stimulator.
| Study group | Role | What they receive |
|---|---|---|
| Apollo Neuro Group | Experimental | The group will use the Apollo Neuro device daily for six weeks as an adjunct to their standard treatment plan. Receives: Device: Apollo Neuro |
| Standard Treatment Group | No intervention | The group will follow their standard treatment plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly changes in concussion symptoms
Index of concussion symptoms using the Sport Concussion Assessment Tool 5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 common concussion symptoms, each rated on a scale from 0 (not present) to 6 (severe).
Measured: pre-intervention and weekly during the intervention
Changes in executive function
Observed functioning will be reported by parents/guardians 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: pre-intervention and after three and six weeks of device use
Change in concussion symptoms from pre-injury levels
Current severity of concussion symptoms in comparison to severity prior to injury will be assessed with the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). The RPQ includes 16 concussion symptoms that are rated in comparison to pre-injury levels from 0 to 4, with higher scores indicating more severe symptoms.
Measured: pre-intervention and after three and six weeks of device use
Changes in anxiety symptoms
Intensity of anxiety symptoms assessed with the Beck Youth Inventory - Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more severe symptoms. T-scores are also included for comparison to normative data.
Measured: pre-intervention and after three and six weeks of device use
Changes in depression symptoms
Index of depression symptoms using the Beck Youth Inventory - Depression scale. Raw scores range from 0 to 60, with higher scores indicating more severe symptoms. T-scores are also included for comparison to normative data.
Measured: pre-intervention and after three and six weeks of device use
Changes in psycho-affective health
Index of psycho-affective health using the Profile of Mood States (POMS). Higher scores on the POMS indicate more intensely experienced mood states.
Measured: pre-intervention and after three and six weeks of device use
Changes in sleep disturbance
Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep subscale. 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: pre-intervention and after three and six weeks of device use
Changes in pain severity
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: pre-intervention and after three and six weeks of device use
Changes in fatigue
Index of pain 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: pre-intervention and after three and six weeks of device use
Changes in headache burden
Index of headache-related burden using the Headache Impact Test-6 (HIT-6). Scores range from 36-78 with higher scores indicating worse outcomes.
Measured: pre-intervention and after three and six weeks of device use
Changes in cognitive function
Performance on the CogState, a validated brain injury cognitive battery.
Measured: pre-intervention and after three and six weeks of device use
Changes in vestibular/ocular motor screening
Visuomotor processing issues associated with concussion, assessed via the Vestibular/Ocular Motor Screening assessment (VOMS).
Measured: pre-intervention and after three and six weeks of device use
Changes in balance
Neuromuscular control assessed via the Modified Balance Error Scoring Screen (mBESS).
Measured: pre-intervention and after three and six weeks of device use
Changes in heart rate variability
Cardio-autonomic function recorded at rest and while under increased physiological demand during a hand grip task.
Measured: pre-intervention and after three and six weeks of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start22 Oct 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT05685121
- Sponsor's protocol ID
- 1926452
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- 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 13 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 With Persistent Post-Concussive Symptoms in Adolescents
- ClinicalTrials.gov ID
- NCT05685121
- Acronym / sponsor ID
- 1926452
- Conditions
- Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Prisma Health-Midlands
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 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 goal of this study is to test a wearable nerve stimulator in adolescents with persistent post-concussive symptoms. The main questions it aims to answer is whether the device will reduce clinical symptom burden, reduce cognitive deficits, and aid in the recovery of clinical symptoms.
Participants will wear the device daily for six weeks and complete a series of assessments.
Detailed description
The primary aim of this study is to evaluate the effectiveness of the Apollo Neuro Device on remediating clinical symptoms, cognitive deficits and physical symptoms of those patients struggling with persisting post-concussive symptoms. The Apollo Neuro Device offers a convenient novel, non-invasive, non-habit-forming solution to improve performance and recovery under stress by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time. The investigators will carry out a prospective study including any individual over the age of ten years presenting with persisting post-concussive symptoms. An Apollo Neuro Device will be offered as part of a treatment plan to patients with chronic neurological symptoms and will be used as an adjunct along with typical treatment. Patients will follow-up for a comprehensive evaluation, per discretion of specialty physicians and weekly symptom surveys will also be emailed to patients to track status. The results of this study will further the understanding of autonomic dysfunction symptomology and recovery and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apollo Neuro Group | Experimental | Device: Apollo NeuroThe group will use the Apollo Neuro device daily for six weeks as an adjunct to their standard treatment plan. |
| Standard Treatment Group | No intervention | –The group will follow their standard treatment plan. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- concussion diagnosis
- able to follow simple instruction
- able to sit upright in a chair for at least 30 minutes without rest
Key exclusion criteria (3 listed)
- previous diagnosis of moderate or severe traumatic brain injury
- neuropsychiatric conditions of schizophrenia or bipolar disorder
- neurophysiological conditions of epilepsy, cerebral palsy, or severe sensory disorders
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 device is a wearable nerve stimulator. | Device | Apollo Neuro Group |
Primary outcome
Weekly changes in concussion symptoms
Time frame: pre-intervention and weekly during the intervention
Index of concussion symptoms using the Sport Concussion Assessment Tool 5 (SCAT-5). The SCAT-5 assesses the presence and severity of 22 common concussion symptoms, each rated on a scale from 0 (not present) to 6 (severe).
Changes in executive function
Time frame: pre-intervention and after three and six weeks of device use
Observed functioning will be reported by parents/guardians 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.
Change in concussion symptoms from pre-injury levels
Time frame: pre-intervention and after three and six weeks of device use
Current severity of concussion symptoms in comparison to severity prior to injury will be assessed with the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). The RPQ includes 16 concussion symptoms that are rated in comparison to pre-injury levels from 0 to 4, with higher scores indicating more severe symptoms.
Changes in anxiety symptoms
Time frame: pre-intervention and after three and six weeks of device use
Intensity of anxiety symptoms assessed with the Beck Youth Inventory - Anxiety scale. Raw scores range from 0 to 60, with higher scores indicating more severe symptoms. T-scores are also included for comparison to normative data.
Changes in depression symptoms
Time frame: pre-intervention and after three and six weeks of device use
Index of depression symptoms using the Beck Youth Inventory - Depression scale. Raw scores range from 0 to 60, with higher scores indicating more severe symptoms. T-scores are also included for comparison to normative data.
Changes in psycho-affective health
Time frame: pre-intervention and after three and six weeks of device use
Index of psycho-affective health using the Profile of Mood States (POMS). Higher scores on the POMS indicate more intensely experienced mood states.
Changes in sleep disturbance
Time frame: pre-intervention and after three and six weeks of device use
Index of sleep disturbance using the Neurological Quality of Life (Neuro-QoL) sleep subscale. 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 severity
Time frame: pre-intervention and after three and six weeks of device use
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 fatigue
Time frame: pre-intervention and after three and six weeks of device use
Index of pain 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 headache burden
Time frame: pre-intervention and after three and six weeks of device use
Index of headache-related burden using the Headache Impact Test-6 (HIT-6). Scores range from 36-78 with higher scores indicating worse outcomes.
Changes in cognitive function
Time frame: pre-intervention and after three and six weeks of device use
Performance on the CogState, a validated brain injury cognitive battery.
Changes in vestibular/ocular motor screening
Time frame: pre-intervention and after three and six weeks of device use
Visuomotor processing issues associated with concussion, assessed via the Vestibular/Ocular Motor Screening assessment (VOMS).
Changes in balance
Time frame: pre-intervention and after three and six weeks of device use
Neuromuscular control assessed via the Modified Balance Error Scoring Screen (mBESS).
Changes in heart rate variability
Time frame: pre-intervention and after three and six weeks of device use
Cardio-autonomic function recorded at rest and while under increased physiological demand during a hand grip task.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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 Concussion, Brain, 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 3 inclusion and 3 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 13 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?
Weekly changes in concussion symptoms (time frame: pre-intervention and weekly during the intervention). The study lists 14 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 13 Jan 2023.