Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)

Not Applicable

Completed

Conditions: Chronic Balance Disorder
Traumatic Brain Injury

Interventions: Device: Cranial nerve non-invasive neuromodulation via PoNS device
Device: Sham PoNS device

Registration Number: NCT02429167

Lead Sponsor: Helius Medical Inc

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 122

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
Willing and able to adhere to the study schedule
Willing to complete a neuropsychological evaluation prior to inclusion

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
Blood pressure abnormalities considered clinically significant
Use of Coumadin or other anticoagulant except aspirin in the last 6 months
Untreated or undiagnosed diabetes
Diabetic neuropathy
Active or recent (within 1 year) treatment for any cancer, excluding basal cell carcinoma.
Neurological disorders other than those attributed to the primary diagnosis (neurodegenerative diseases such as Multiple Sclerosis, Parkinson's disease, Alzheimer's disease or other dementia, Amyotrophic Lateral Sclerosis)
History of epileptic or other seizure disorders
Known ischemic heart disease and/or history or atrial or ventricular arrhythmias with or without syncope
Any other untreated or unstable acute or chronic, clinically significant medical condition for which the subject is currently undergoing treatment that the study investigator deems unsuitable for inclusion
Use of a lower extremity biomechanical prosthetic with the exception of a splint for foot drop
Females who are pregnant, lactating, or planning to become pregnant during the study
Chronic use of any potentially interfering medication, or use of any medication that would compromise the ability to function or perform the study activities
Addition of and/or major change in type or dosage of any prescription medication within 3 months prior to receipt of the PoNS device
Active alcoholism. The study investigator will have the right to exclude subject participation if the subject seems intoxicated at time of screening and/or during any study appointment.
History of drug abuse will be assessed
Recent history of smokeless tobacco use
Any reason that may be a threat to health or safety
Any finding in the neuropsychological evaluation that makes the subject unsuitable for inclusion

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PoNS Device	Cranial nerve non-invasive neuromodulation via PoNS device	Cranial nerve non-invasive neuromodulation via PoNS device. The system delivers 19 V pulses to the tongue (a nominal 5.5 kilo-ohm load).
Sham PoNS Device	Sham PoNS device	The sham control device appears physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, thereby providing minimal, if any, cranial nerve non-invasive neuromodulation via PoNS device

Primary Outcome Measures

Name	Time	Method
Response to treatment defined as an 8 point change in the Sensory Organization Test (SOT) from baseline	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3): Orlando Health
🇺🇸
Orlando, Florida, United States
The Montreal Neurofeedback Center
🇨🇦
Montreal, Quebec, Canada
Oregon Health and Science University Center for Regenerative Medicine
🇺🇸
Portland, Oregon, United States