Double Blind, Randomized, Sham Controlled Study of Safety and Effectiveness of the Portable Neuromodulation Stimulator (PoNS) Device for Cranial Nerve Noninvasive Neuromodulation Training for Chronic Balance Deficit Due to Mild/Moderate TBI
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Helius Medical Inc
- Enrollment
- 122
- Locations
- 3
- Primary Endpoint
- Response to treatment defined as an 8 point change in the Sensory Organization Test (SOT) from baseline
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of the study device in conjunction with physical therapy will improve balance and gait in patients suffering from a TBI. The effects of using the device and undergoing therapy will be measured using standardized tests of movement control, gait, headache and other TBI symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, 18-65 years of age
- •Documentation on initial TBI (defined as closed-head, non-penetrating, blunt, whiplash, or explosive blast-induced brain injury) severity (at time of injury): Glasgow Coma Scale (GCS) score 9-15, with loss of consciousness \< 24 hours, post-traumatic amnesia ≤7 days, or hospital admission ≤ 7 days post TBI
- •If female, subject is not pregnant, not lactating, has a negative pregnancy test prior to receipt of the PoNS™ device, and agrees to use contraception from screening to end of the study
- •Balance disorder with SOT composite score at least 16 points below normal resulting from a mild/moderate TBI without any concomitant pathologies
- •At least 1 year post injury
- •Stable neurologic status
- •Prior participation in a focused physical rehabilitation program for TBI and deemed by their treating clinician/themselves to have reached a plateau
- •Able to walk continuously on a treadmill for 20 minutes, level grade and at any speed, with support if needed
- •Access to a treadmill and commitment to utilize this for the at-home portion of the study
- •Able to understand the study procedures and give informed consent
Exclusion Criteria
- •Medical finding from screening history and physical examination that is clinically significant or would otherwise impact patient safety or data integrity
- •Medical finding from prior neuroradiologic study or recent MRI that is significant or that would impact patient safety or data integrity
- •Planned use or use of any investigational product, pharmaceutical or device within 30 days preceding receipt of the PoNS device and during the entire study
- •Balance or gait deficits due to lower extremity injury or neurological condition other than TBI
- •Penetrating brain injury, craniotomy or refractory subdural hematoma
- •Oral health problems at the time of recruitment
- •Oral surgery within 3 months of screening
- •History of oral cancer
- •Non-removable metal orthodontic devices that could interfere with PoNS use
- •Presence of metallic implant or other MRI-incompatible device
Outcomes
Primary Outcomes
Response to treatment defined as an 8 point change in the Sensory Organization Test (SOT) from baseline
Time Frame: 5 weeks after the start of the intervention
The SOT is an objective, automated measure of sensory-motor integration that evaluates the functional contribution of the somatosensory, visual, and vestibular components of balance. A composite score is calculated and compared with a database normalized for age and height.
Secondary Outcomes
- Increase in SOT score from pre-training SOT score at the end of 2 weeks in lab training(Two weeks after start of the intervention)