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

University of South Carolina

Status: Enrolling

Conditions: Concussion, Brain

Treatments: Device: Apollo Neuro

Study type: Interventional

Funder types: Other

Identifiers

NCT05685121

1926452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Apollo Neuro Group

Experimental group

Description:

The group will use the Apollo Neuro device daily for six weeks as an adjunct to their standard treatment plan.

Treatment:

Device: Apollo Neuro

Standard Treatment Group

No Intervention group

Description:

The group will follow their standard treatment plan.