taVNS Effect on Central Auditory Processing

NCT06970444 | Completed

• 1 other identifier: MedipolU-Aud-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The behavioral effects of vagus nerve stimulation (VNS) and observed activation in the auditory cortex with transcutaneous auricular VNS (taVNS) raise questions about their potential impact on auditory processing. This study aims to investigate whether taVNS, which has not been studied in the context of central auditory processing (CAP), has any effects on CAP.

Conditions

Central Auditory Disease; Auditory Processing Disorder, Central; Auditory Processing Disorders; Vagus Nerve Stimulation

Keywords

central auditory processing; transcutaneous auricular vagus nerve stimulation; central auditory processing disorder; aural rehabilitation

Outcome Measures

Primary Outcomes (2)

• Frequency Patterns Test (FPT)

  FPT is a test battery developed to evaluate temporal sequencing ability, which is one of the subcategories of temporal processing. In our study, for FPT, an audio -mp3- file based on the parameters determined by Musiek was applied. The high frequency sound used as test stimulus frequencies was determined as 1122 Hz, and the low frequency sound was determined as 880 Hz. The length of the stimulus period was determined as 200 ms, and the inter-stimulus interval was 150 ms. There is a 10 ms rise-fall time between the stimuli. There were six possible combinations of tones (Low-Low-High (LLH), LHL, LHH, HLH, HLL and HHL). Participants were asked to verbally rank the sounds they heard according to their frequency and order of occurrence, and several stimulus sets were presented for trial purposes before the test, not to be included in the scoring.

  Immediately before and after the stimulation (totally: 30 min)

• Duration Patterns Test (DPT)

  It is a test set that measures another temporal sequencing skill known as DPT (Musiek et al., 1990). In our study, sound recording for DPT was made using an audiometer in line with the criteria determined by Musiek. Stimuli were presented at a frequency of 1000 Hz. Long duration sounds were determined as 500 ms, and short duration sounds were determined as 250 ms. There was a 10 ms rise and fall time between stimuli. The interstimulus interval was set at 300 ms. There were six possible combinations of tones (Long-Long-Short (LLS), LSS, LSL, SLL, SSL, SLS). Participants were asked to verbally rank the sounds they heard according to their duration and the order in which they were presented, and stimulus sets were presented for trial purposes not to be included in the scoring. Before the test began, participants were asked to indicate their readiness. Stimuli were presented in a total of 50 sets, 25 triple stimuli for each ear, at 60 dB HL level, and separate DPT scores were calculated.

  Immediately before and after the stimulation (totally: 30 min)

Study Arms (2)

taVNS Group

EXPERIMENTAL

The group which recieved taVNS stimulation through their left ear

Device: transcutaneous auricular vagus nerve stimulation (taVNS)

Sham (Placebo) g,Group

SHAM COMPARATOR

control group received sham stimulation with the stimulator closed and electrodes placed in their left ear

Other: Sham device

Interventions

transcutaneous auricular vagus nerve stimulation (taVNS) DEVICE

Transcutaneous auricular vagus nerve stimulation (taVNS) is an emerging non-invasive therapy that modulates brain activity by delivering electrical impulses to the auricular branch of the vagus nerve at the outer ear (Badran et al., 2018). taVNS subsequently stimulates the nucleus of tractus solitarius via the afferent vagus nerve fibers. The nucleus solitarius sends outputs to the hypothalamus, which is critical for sensory processing, including auditory processing, and also activates various brain regions, including the locus coeruleus, resulting in the release of neurotransmitters such as norepinephrine and serotonin, which are involved in neural plasticity and cognitive function, which is important for CAP. Another theory for taVNS effects is the release of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, which may further help to balance abnormal neural activity in auditory circuits.

taVNS Group

Sham device OTHER

the control group received sham stimulation with the stimulator closed and electrodes placed in their left ear

Sham (Placebo) g,Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 18-40 years old
• Having a score of 21 or above on the MoCA test
• Having a normal range on the bilateral pure tone audiometry test
• Having no problems on any scanner
• Having no professional music background
• Having right hand dominance
• Having no contraindication to T-a-VNS

You may not qualify if:

• Peripheral hearing disorders
• Professional music history
• Physical and emotional disorders that may affect the test results
• Left-hand dominance
• Persons in whom the use of T-a-VSU is contraindicated

Sponsors & Collaborators

• Medipol University: lead
• Bahçeşehir University: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34000, Turkey (Türkiye)

Location

Related Publications (4)

• De Taeye L, Vonck K, van Bochove M, Boon P, Van Roost D, Mollet L, Meurs A, De Herdt V, Carrette E, Dauwe I, Gadeyne S, van Mierlo P, Verguts T, Raedt R. The P3 event-related potential is a biomarker for the efficacy of vagus nerve stimulation in patients with epilepsy. Neurotherapeutics. 2014 Jul;11(3):612-22. doi: 10.1007/s13311-014-0272-3.

  PMID: 24711167 BACKGROUND

• Peng L, Mu K, Liu A, Zhou L, Gao Y, Shenoy IT, Mei Z, Chen Q. Transauricular vagus nerve stimulation at auricular acupoints Kindey (CO10), Yidan (CO11), Liver (CO12) and Shenmen (TF4) can induce auditory and limbic cortices activation measured by fMRI. Hear Res. 2018 Mar;359:1-12. doi: 10.1016/j.heares.2017.12.003. Epub 2017 Dec 24.

  PMID: 29305037 BACKGROUND

• Musiek, F. E. (2002). The frequency pattern test: A guide. Hearing Journal, 55(6), 58. https://doi.org/10.1097/01.HJ.0000293280.99394.DD

  BACKGROUND

• Musiek FE. Frequency (pitch) and duration pattern tests. J Am Acad Audiol. 1994 Jul;5(4):265-8.

  PMID: 7949300 BACKGROUND

MeSH Terms

Conditions

Auditory Diseases, Central; Language Development Disorders; Auditory Perceptual Disorders

Condition Hierarchy (Ancestors)

Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ayberk Aydin Tunç, Master of Science

  Istanbul Medipol University, Audiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Audiologist, M.Sc.

Model Details: We evaluate the Central Processing skills before and after the stimulations (real and sham stimulation). This was a non-invasive stimulation.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: May 14, 2025
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 19, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)