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RECRUITINGINTERVENTIONAL

Improving Speech in Noise Using Noninvasive Stimulation

Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Traumatic brain injury, a common injury in military service personnel, often leads to poor processing of speech in noisy environments. The goal of the current study is to better understand the brain basis for this difficulty and evaluate a new approach to improving speech in noise perception.

Who May Be Eligible (Plain English)

Who May Qualify: - 25-55 years old - Proficiency in English - TBI group: history of traumatic brain injury by blast or physical trauma - Normal hearing group: no history of traumatic brain injury Who Should NOT Join This Trial: - Other neurological diseases or related conditions will be excluded (e.g., large vessel stroke, seizures). We will exclude patients with severe medical diseases that may be associated with impaired cognition (e.g., heart failure, dialysis dependent kidney disease, brain cancer). Further, psychiatric diseases that are unlikely to be related to trauma will be excluded (e.g., schizophrenia). Patients with histories of severe psychiatric disease prior to trauma exposure will be excluded. - Current illicit or prescription drug abuse (within the last two months) - Any taVNS contraindication, including but not limited to the presence of unremovable metal in the left ear, known heart conditions, medications that influence neurotransmitters thought to be critical for vagus nerve stimulation (norepinephrine, acetylcholine, and serotonin), or implanted medical devices such as a pacemaker. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 25-55 years old * Proficiency in English * TBI group: history of traumatic brain injury by blast or physical trauma * Normal hearing group: no history of traumatic brain injury Exclusion Criteria: * Other neurological diseases or related conditions will be excluded (e.g., large vessel stroke, seizures). We will exclude patients with severe medical diseases that may be associated with impaired cognition (e.g., heart failure, dialysis dependent kidney disease, brain cancer). Further, psychiatric diseases that are unlikely to be related to trauma will be excluded (e.g., schizophrenia). Patients with histories of severe psychiatric disease prior to trauma exposure will be excluded. * Current illicit or prescription drug abuse (within the last two months) * Any taVNS contraindication, including but not limited to the presence of unremovable metal in the left ear, known heart conditions, medications that influence neurotransmitters thought to be critical for vagus nerve stimulation (norepinephrine, acetylcholine, and serotonin), or implanted medical devices such as a pacemaker.

Treatments Being Tested

DEVICE

Cymba Conchae stimulation

Electrical stimulation applied to the cymba conchae region of the outer ear

DEVICE

Earlobe stimulation

Electrical stimulation applied to the earlobe region of the outer ear

Locations (1)

UF Health at the University of Florida
Gainesville, Florida, United States