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Central Auditory DiseaseNCT06970444

taVNS Effect on Central Auditory Processing

A study testing transcutaneous auricular vagus nerve stimulation (taVNS) in people with Central Auditory Disease and Auditory Processing Disorder, Central, run by Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
transcutaneous auricular vagus nerve stimulation (taVNS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2023to 19 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Beykoz, 34000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Auditory Processing Abilities in Healthy Individuals

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.

Read the detailed description

Experimental procedure First, the participants were made to sign the 'Informed Volunteer Consent Form'. Then, the MoCA test was applied, and pure tone audiometry test was performed on those who scored 21 or above and were determined to have normal cognitive abilities. After air and bone conduction pure tone thresholds were determined, speech reception thresholds with three-syllable phonetically balanced words and Speech Discrimination Scores (SDS) with monosyllabic phonetically balanced words were measured. Participants with normal hearing were included in the study. Central Auditory Processing (CAP) tests, Frequency Patterns Test (FPT) and Duration Patterns Test (DPT) were applied to the participants in the study group separately for each ear, and the current situation in the CAP evaluation was recorded. Then, taVNS was applied to left ear for 15 minutes with a biphasic, square stimulus with a pulse width of 250 µs, a stimulus at the sensor threshold level and a frequency of 20 Hz. The control group received sham stimulation with the stimulator closed and electrodes placed. After the stimulations, CAP tests were repeated for each ear separately. Differences between the study and control groups were examined. The application was performed in a dimly lit, sound-insulated double-walled cabin (a sound-insulated room in accordance with Industrial Acoustics 18 Company [IAC] standards), while sitting in a comfortable chair. The audio file was opened from the desktop computer and sent via the aux cable to the clinical audiometer device (AC40 Clinical Audiometer). The participant listened to the sound through supraaural headphones (TDH39).

70 healthy participants with 140 ears were included in the study. Participants were 18-40 years old. 40 people; 20 females (23,20±2,35 mean of years) were included in the study group with active taVNS and 30 people; 15 females (23,30±3,48 mean of years) were included in the control group. All participants were native Turkish speakers with normal cognitive conditions and hearing which has been demonstrated by routine tests. Further inclusion criteria were: age 18-40 years, normal CAP performance. The age range of the study was determined by taking into account that CAP skills decrease with increasing age. In order to eliminate heterogeneity, male-female balance was taken into account. As the effect of hemispheric lateralization, those with left hand dominance had differences in language skills and spatial attention, and in verbal and non-verbal behavioral tasks, compared to those with right hand dominance, only individuals with right hand dominance were included in the study, taking into account that it may affect the test results. Musical training is an important factor in FPT performance as it provides better frequency discrimination perception. Therefore, individuals with a professional music background were not included in the study, as it was thought that it could affect brain organization and cause differences in test results.

To evaluate cognitive functions, the MoCA test, was applied to the participants. Who scored 21 or above were determined to have normal cognitive abilities.

To confirm that the hearing abilities of the individuals participating in the study were normal, a pure tone and speech audiometry test and FPT-DPT test batteries were performed using the Interacoustic AC40 (Denmark) audiometer device. The hearing thresholds of octave band frequencies thresholds of 250 Hz to 8000 Hz were 25 dB or lower were considered normal.

FPT and DPT were applied to the participants, respectively. During or at the end of the tests, breaks were taken according to the participants' wishes so that they could focus.

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. The test started when the participant indicated that she/he was ready. Stimuli were presented at 60 dB HL through TDH-39 over-ear headphones. Participants were presented with a total of 50 sets of stimuli, 25 triple stimuli for each ear, and FPT scores were calculated as a percentage for both ears separately.

It is a test set that measures another temporal sequencing skill known as DPT. 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 for both ears.

FPT and DPT allow participants to express some of the stimulus patterns presented to them in reverse. In the literature, 2 score types have been defined in which this situation is accepted as a right or wrong. In our study, scoring was done according to both score types.

These score types are listed below:

Rev Plus: Score type calculated by accepting the reversed patterns as correct that we mentioned as "Rev." in the tables.

Rev Minus: Score type calculated by accepting the reversed patterns as incorrect.

taVNS parameters After the first CAP evaluations of the participants in the study group, taVNS was applied via VAGUSTIM TENS (Vagustim Health Technologies, San Francisco, CA, USA) device. Stimulating electrodes were placed on the inner surface of the left ear between the tragus and concha (Figure2). Ultrasound gel was applied to the electrodes during placement to increase electrical conduction. Then, stimulation parameters adjusted and stimulation started. The stimulation amplitude increased gradually, with the guidance of the participants, at a comfortable level (sensory treshold level), where the stimulation was felt but did not cause pain or discomfort. Stimulation time was set as 15 minutes. Stimulation duration was limited to 15 minutes to prevent possible side effects like hypotension, dizziness, etc.

Stimulus parameters used when applying taVNS to the left ear: In the study of Peng et al., the stimulus parameters proven by f-MRI to create activity in the auditory cortex were taken as a reference. A biphasic modified square stimulus with a pulse width of 250 µs. Electric current amplitude threshold was adjusted according to participant tolerance. The stimulation frequency was kept at 20 Hz, which is known to activate nerve fibers.

Being tested
transcutaneous auricular vagus nerve stimulation (taVNS), Sham device
Keywords
central auditory processing, transcutaneous auricular vagus nerve stimulation, central auditory processing disorder, aural rehabilitation
Medical subject headings
Auditory Diseases, Central, Language Development Disorders, Auditory Perceptual Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Sham deviceOther

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

Study groups in NCT06970444
Study groupRoleWhat they receive
taVNS GroupExperimentalThe group which recieved taVNS stimulation through their left ear
Receives: Device: transcutaneous auricular vagus nerve stimulation (taVNS)
Sham (Placebo) g,GroupSham comparatorcontrol group received sham stimulation with the stimulator closed and electrodes placed in their left ear
Receives: Other: Sham device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2025
  2. Study start1 Apr 2023
  3. Primary completion1 May 2024
  4. Study completion19 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
We evaluate the Central Processing skills before and after the stimulations (real and sham stimulation). This was a non-invasive stimulation.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06970444
Sponsor's protocol ID
MedipolU-Aud-01
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24711167
  • 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.

    PubMed 29305037
  • 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

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

    PubMed 7949300

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous auricular vagus nerve stimulation (taVNS) in people with Central Auditory Disease and Auditory Processing Disorder, Central, run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency Patterns Test (FPT) (time frame: Immediately before and after the stimulation (totally: 30 min)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06970444, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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