Summary:
A clinical research study is evaluating a new medical device that may improve balance and walking for those affected by mild to moderate TBI.
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 traumatic brain injury (TBI).
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
Sensations when using the PoNS™ device 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.
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.
The study has been determined to be of nonsignificant risk.
Participation for this study would require a 6-7 week commitment for screening, in-clinic training, and at home training. Please note that compensation for time and travel is available for eligible participants.
Study Criteria:
You may be eligible to participate if you:
- Have experienced a concussion or head or brain injury more than a year ago
- Are between the ages of 18 and 65
- Have difficulty with balance
- Are able to walk for at least 20 minutes (with support, if needed)
- Did not lose consciousness for more than 24 hours when you were injured
- Have previously participated in a physical rehabilitation program for TBI and saw limited success or reached a plateau
Eligibility can only be determined by contacting study staff.
PoNS™ is an investigational device still being tested, and is not cleared or approved for commercial distribution in the United States or Canada.