Medical Researchers are conducting a study to determine the effectiveness of an investigational device for individuals with balance problems due to brain injury.
This study will test a new intervention that combines the use of an investigational device that provides mild electrical stimulation to the tongue with physical therapy exercises, to improve balance and walking.
Medical Researchers are conducting a double-blind, randomized, controlled study to evaluate whether balance can be improved using a device that delivers mild levels of electrical stimulation combined with physical therapy in individuals with mild to moderate brain injury.
The Brain Injury Trial, a double-blind, randomized, and controlled study, will evaluate a small, non-invasive medical device held in the mouth that delivers a mild electrical stimulation to the tongue while performing several physical therapy exercises.
The portable device is held lightly in place by the lips and teeth around a tab that rests on the top of the tongue. During treatment, the device delivers a mild electrical stimulation to the nerves in the tongue. Nerves found in the tongue extend to several important brain structures. Researchers are evaluating if the stimulation of these brain structures through the tongue, in combination with physical therapy may improve symptoms of brain injury.
Everyone’s tongue is unique. Some people feel almost nothing, some feel a mild sensation similar to carbonated beverages. Although the stimulation may feel unusual, it is mild enough that it will only be able to be felt by the tongue and lips. The study has been determined to be of non-significant risk.
If you have had limited success, or have reached a plateau with your post-brain injury physical therapy, this study may be an option for you.
Only the Research Trial Staff can fully determine if you qualify to enroll in the study,
however answering these 5 questions now can help determine your eligibility.
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Only the study doctor can fully determine if you qualify to enroll in the study, but answering these 5 questions now can help determine your eligibility.
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Thank you for your interest in the Brain Injury Trial. However, you do not meet the pre-screen requirements at this time. Please contact your doctor with any medical questions that you may have.
Are you 18-65 years old?
Have you experienced a concussion, head or brain injury?
Do you have difficulty with balance?
Are you able to walk for at least 20 minutes (with support, if needed)?
Did you lose consciousness for more than 24 hours after your injury?