Medical researchers in the United States and Canada are investigating whether using a new medical device—the Portable Neuromodulation Stimulator (PoNS™)—in combination with physical therapy can improve chronic symptoms of TBI.
The Brain Injury Clinical Trial is a randomized, controlled study that is taking place at various medical centers.
Compensation for time and travel is available for qualified participants.
Cranial nerves in the tongue extend to several important brain structures. Researchers are investigating whether the stimulation of these brain structures, through the tongue, in combination with physical therapy, may improve chronic symptoms of concussion, head or brain injury.
During treatment, the portable PoNS™ device* is held in the mouth and delivers a mild electrical stimulation to the nerves in the tongue while participants perform physical therapy exercises.
*It is important to note that PoNS™ is an investigational device still being tested and is not cleared or approved for commercial distribution in the United States or Canada.
Clinical trials are scientific research studies that test how safe and effective a new treatment is for a particular condition or disease. The US Food and Drug Administration (FDA) and Health Canada are the agencies that oversee clinical trials in the United States and Canada, respectively. The Brain Injury Clinical Trial is in phase III of testing, which is the phase that determines whether or not a treatment receives regulatory clearance.
Clinical trials might be described as pipelines of hope for the development of new, more effective treatments that improve lives. People participate for various reasons, including a desire to help advance scientific research and to help themselves and others potentially gain access to new treatments.
A TBI is an injury to the head (eg, concussion, or head or brain injury) that disrupts the normal functions of the brain. A TBI can be caused in a variety of ways, including playing sports, vehicle accidents, military combat, violent assaults, and slips or falls, among others.
Each year in the United States, approximately 2.5 million emergency room visits and hospitalizations are associated with TBI, according to the Centers for Disease Control. Additionally, it’s estimated that, at any point in time, more than 5 million people live with lingering TBI symptoms.
Symptoms of a mild traumatic brain injury may take days, weeks, or months to appear and may include: headaches, nausea, head or neck pain, seizures, slurred speech, loss of balance, fatigue, dizziness, weakness or numbness in arms or legs, vision disturbances, and balance problems, among others. Talk with your doctor if you have or think you may have experienced a TBI.
Leading medical researchers are partnering with Helius Medical Technologies to conduct this study at medical centers in the United States and Canada. The Brain Injury Association of America is another partner in raising awareness about the trial and TBI.
You may qualify to participate if you:
Take the brief questionnaire to see if you qualify. Complete eligibility may only be determined once study staff is contacted.
If you qualify to participate in this 5-week study, you will be asked to:
Sensations vary. You may feel a sensation similar to what it feels like to drink a carbonated beverage. The stimulation is mild enough that it will only be able to be felt by the tongue and lips.
If you have limited success or have reached a plateau with your post–brain injury physical therapy, this study may be an option for you. Take the brief questionnaire to see if you’re eligible.
FDA regulation 21 CFR 812 is focused on the classification of the device. The device has been determined to not meet the definition of a significant risk device under 812.3(m), therefore it has been given the determination of a nonsignificant risk (NSR) device by the FDA. Participants will review any additional risks associated with the conduct of the study during the informed consent process.
Please note that compensation for time and travel is available for qualified participants.