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| ID | Type | Description | Link |
|---|---|---|---|
| RH240016 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A vs Treatment B | Other | Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear. |
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| Treatment B then Treatment A | Other | Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cymba Conchae stimulation | Device | Electrical stimulation applied to the cymba conchae region of the outer ear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and feasibility | quantify attrition as well as frequency and severity of adverse events | From enrollment to the end of treatment is between 2 days and 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech in Noise performance | Percent correct on a speech in noise perception task when receiving Treatment A compared to Treatment B | Baseline and one week |
| Brain response patterns | Pattern of brain response while listening to speech in background noise while receiving Treatment A compared to Treatment B |
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Inclusion Criteria:
Exclusion Criteria:
Patients with histories of severe psychiatric disease prior to trauma exposure will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
De-identified data will be shared at the time of data publication
Data will be shared at the time of publication and will be available indefinitely
Data and protocols will be shared openly.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Earlobe stimulation | Device | Electrical stimulation applied to the earlobe region of the outer ear |
|
|
| Baseline and one week |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |