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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UF Health at the University of Florida

Gainesville, Florida, United States, 32610