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call: 1-877-844-4960

Compensation is available for qualified participants.

About the Study

Medical Researchers are conducting a study to determine the effectiveness of an investigational device for individuals with balance problems due to brain injury.

About the Investigational Device

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.

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About the Study

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.

You may be eligible if you:

  • Are between the ages 18 and 65,
  • Have experienced a concussion, head or brain injury, over 1 year ago,
  • Have difficulty with balance,
  • Are able to walk for at least 20 minutes (with support, if needed), and
  • Did not lose consciousness for more than 24 hours when you were injured.

 

If you qualify to participate in this 5 week study you will be asked to:

  • Use an investigational medical device while performing physical therapy exercises;
  • Spend the first 2 weeks (M-F, approx. 3 hrs/day) at the Medical Research Lab for initial physical therapy;
  • Continue physical therapy at home for 3 weeks (approx. 2 hrs per day);
  • Return to the Medical Research Lab for physical therapy sessions weekly and follow-up assessments.

 

Compensation

  • Compensation is available for qualified participants.

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About the Investigational Device

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.

How does the device work?

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.

What does the stimulation feel like?

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.

How do I know that this study is right for me?

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.

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Am I Eligible?

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.

Am I Eligible?

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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