Improving Speech in Noise Using Noninvasive Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cymba Conchae stimulation, Earlobe stimulation.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury, Hearing Loss. Basic parameters: 25 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Noninvasive Vagus Nerve Stimulation for Improved Speech in Noise Perception
Overview
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
- Device Cymba Conchae stimulation
Electrical stimulation applied to the cymba conchae region of the outer ear - Device Earlobe stimulation
Electrical stimulation applied to the earlobe region of the outer ear
Primary outcome measures
- Safety and feasibility [Time frame: From enrollment to the end of treatment is between 2 days and 2 weeks.]
Secondary outcome measures (2)
- Speech in Noise performance [Time frame: Baseline and one week]
- Brain response patterns [Time frame: Baseline and one week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- UF Health at the University of Florida — Gainesville
Identifiers
NCT: NCT07176936 · IRB202500139 · RH240016