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

Last updated: January 6, 2023
Sponsor: University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Treatment

N/A

Clinical Study ID

NCT05685121
1926452
  • Ages > 10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • concussion diagnosis
  • able to follow simple instruction
  • able to sit upright in a chair for at least 30 minutes without rest

Exclusion

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

Study Design

Total Participants: 100
Study Start date:
October 22, 2021
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Prisma Health Pediatric Concussion Clinic

    Columbia, South Carolina 29203
    United States

    Active - Recruiting

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