A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated With Persistent Post-Concussive Symptoms in Adolescents

Conditions
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Concussion, Brain

Intervention / Treatment
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* Device: Apollo Neuro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: concussion diagnosis able to follow simple instruction able to sit upright in a chair for at least 30 minutes without rest Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apollo Neuro Group<br>The group will use the Apollo Neuro device daily for six weeks as an adjunct to their standard treatment plan. | Device: Apollo Neuro<br>* The device is a wearable nerve stimulator.<br>|
| No Intervention: Standard Treatment Group<br>The group will follow their standard treatment plan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | pre-intervention and after three and six weeks of device use |