Clinical trial NCT05685121: A Wrist-Worn Nerve Stimulator for Remediating Persistent Post-Concussive Symptoms in Adolescents
Official title: A Wearable Wrist-Worn Nerve Stimulator for Remediating Autonomic Dysfunction Associated With Persistent Post-Concussive Symptoms in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Prisma Health-Midlands
First posted: 2023-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weekly changes in concussion symptoms
timeFrame: pre-intervention and weekly during the intervention
measure: Changes in executive function
timeFrame: pre-intervention and after three and six weeks of device use
measure: Change in concussion symptoms from pre-injury levels
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in anxiety symptoms
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in depression symptoms
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in psycho-affective health
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in sleep disturbance
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in pain severity
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in fatigue
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in headache burden
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in cognitive function
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in vestibular/ocular motor screening
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in balance
timeFrame: pre-intervention and after three and six weeks of device use
measure: Changes in heart rate variability
timeFrame: pre-intervention and after three and six weeks of device use
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Prisma Health Pediatric Concussion Clinic
state: South Carolina
Study officials:
References: