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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-22

Study Completion Date

2024-09-30

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.

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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.

Conditions

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Concussion, Brain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apollo Neuro Group

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

Group Type EXPERIMENTAL

Apollo Neuro

Intervention Type DEVICE

The device is a wearable nerve stimulator.

Standard Treatment Group

The group will follow their standard treatment plan.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Apollo Neuro

The device is a wearable nerve stimulator.

Intervention Type DEVICE

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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No