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

NCT05685121 | Unknown

• 1 other identifier: 1926452
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Apollo Neuro Group

EXPERIMENTAL

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

Device: Apollo Neuro

Standard Treatment Group

NO INTERVENTION

The group will follow their standard treatment plan.

Interventions

Apollo Neuro DEVICE

The device is a wearable nerve stimulator.

Apollo Neuro Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Prisma Health-Midlands: collaborator

Study Sites (1)

Prisma Health Pediatric Concussion Clinic

Columbia, South Carolina, 29203, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

R. Davis Moore, PhD

CONTACT

803-777-3278; moorerd3@mailbox.sc.edu

Jacob Kay, PhD

CONTACT

803-434-8885; jacob.kay@prismahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 13, 2023
• Study Start: October 22, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)