Improving Speech in Noise Using Noninvasive Stimulation

University of Florida

Status: Not yet enrolling

Conditions: Traumatic Brain Injury; Hearing Loss

Treatments: Device: Cymba Conchae stimulation; Device: Earlobe stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07176936

RH240016 (Other Grant/Funding Number)

IRB202500139

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Treatment A vs Treatment B

Other group

Description:

Participants will receive the stimulation at location A and then receive stimulation at location B, both on the outer ear.

Treatment:

Device: Earlobe stimulation

Device: Cymba Conchae stimulation

Treatment B then Treatment A

Other group

Description:

Participants will receive the stimulation at location B and then receive stimulation at location A, both on the outer ear.

Treatment:

Device: Earlobe stimulation

Device: Cymba Conchae stimulation