Hearing Loss, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
DEVICECymba Conchae stimulation
Electrical stimulation applied to the cymba conchae region of the outer ear
DEVICEEarlobe stimulation
Electrical stimulation applied to the earlobe region of the outer ear
Sponsors
University of Florida
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and feasibility | From enrollment to the end of treatment is between 2 days and 2 weeks. | quantify attrition as well as frequency and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech in Noise performance | Baseline and one week | Percent correct on a speech in noise perception task when receiving Treatment A compared to Treatment B |
| Brain response patterns | Baseline and one week | Pattern of brain response while listening to speech in background noise while receiving Treatment A compared to Treatment B |
Countries
United States
Outcome results
None listed