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

Concussion, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685121
• Other study ID #: 1926452
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: September 2024

Study information

• Verified date: January 2023
• Source: University of South Carolina
• Contact: R. Davis Moore, PhD
• Phone: 803-777-3278
• Email: moorerd3[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants will wear the device daily for six weeks and complete a series of assessments.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain
• Post-Concussion Syndrome

Intervention

Device:
• Apollo Neuro
The device is a wearable nerve stimulator.

Locations

Country	Name	City	State
United States	Prisma Health Pediatric Concussion Clinic	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Prisma Health-Midlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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