Status:
NOT_YET_RECRUITING
Improving Speech in Noise Using Noninvasive Stimulation
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Traumatic Brain Injury
Hearing Loss
Eligibility:
All Genders
25-55 years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT07176936
Start Date
January 15 2026
End Date
August 31 2027
Last Update
December 5 2025
Active Locations (1)
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1
UF Health at the University of Florida
Gainesville, Florida, United States, 32610