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

January 6, 2023 updated by: Robert Davis Moore, University of South Carolina

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Pediatric Concussion Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apollo Neuro Group
The group will use the Apollo Neuro device daily for six weeks as an adjunct to their standard treatment plan.
Device: Apollo Neuro
The device is a wearable nerve stimulator.
No Intervention: Standard Treatment Group
The group will follow their standard treatment plan.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weekly changes in concussion symptoms
Time Frame: pre-intervention and weekly during the intervention
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
Changes in executive function
Time Frame: pre-intervention and after three and six weeks of device use
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
Change in concussion symptoms from pre-injury levels
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in anxiety symptoms
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in depression symptoms
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in psycho-affective health
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in sleep disturbance
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in pain severity
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in fatigue
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in headache burden
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in cognitive function
Time Frame: pre-intervention and after three and six weeks of device use
Performance on the CogState, a validated brain injury cognitive battery.
pre-intervention and after three and six weeks of device use
Changes in vestibular/ocular motor screening
Time Frame: pre-intervention and after three and six weeks of device use
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
Changes in balance
Time Frame: pre-intervention and after three and six weeks of device use
Neuromuscular control assessed via the Modified Balance Error Scoring Screen (mBESS).
pre-intervention and after three and six weeks of device use
Changes in heart rate variability
Time Frame: pre-intervention and after three and six weeks of device use
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prisma Health-Midlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1926452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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