Recruiting

Nerve Stimulator

Sponsor:

University of South Carolina

Code:

NCT05685121

Conditions

Concussion, Brain

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

Apollo Neuro

Study Details

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

Study ID

NCT05685121

Start date

Oct 22, 2021

Status verified date

Jan, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Apollo Neuro Group

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

no intervention: Standard Treatment Group

The group will follow their standard treatment plan.

Interventions

Apollo Neuro

The device is a wearable nerve stimulator.

Primary outcome measure

  • Weekly changes in concussion symptoms [ Time Frame: pre-intervention and weekly during the intervention ]
  • Changes in executive function [ Time Frame: 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 ]
  • Changes in anxiety symptoms [ Time Frame: 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 ]
  • Changes in psycho-affective health [ Time Frame: 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 ]
  • Changes in pain severity [ Time Frame: 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 ]
  • Changes in headache burden [ Time Frame: 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 ]
  • Changes in vestibular/ocular motor screening [ Time Frame: 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 ]
  • Changes in heart rate variability [ Time Frame: pre-intervention and after three and six weeks of device use ]

Central Contacts and Locations

Central contacts

R. Davis Moore, PhD

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

Jacob Kay, PhD

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

Locations

Prisma Health Pediatric Concussion Clinic

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Jacob Kay, PhD

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

More Information

Sponsor

University of South Carolina

Last update posted

Jan 13, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2023-01-13.