Transcranial Electrical and Acoustic Stimulation for Tinnitus

Tinnitus Clinical Trial

— tEAS  

Official title:

Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551404
• Other study ID #: tEAS
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcranial electrical stimulation (tES) is an umbrella term for non-invasive brain stimulation using weak currents. It comprises transcranial direct current stimulation (tDCS), which is the most established and used method applying constant direct current, transcranial alternating current stimulation (tACS) with sinusoidal current in a fixed frequency, and finally transcranial random noise stimulation (tRNS), which is a subform of tACS generating a random range of low and high frequency alternating currents.

A pilot study conducted by Shekhawat and colleagues in 2015 tested the effects of simultaneous electrical and acoustic stimulation. Using tDCS and bilateral broadband noise simultaneously, they found that more tinnitus patients report an improvement in tinnitus perception in comparison to conditions only using tDCS or sham. Further similar approaches very published in recent years, namely a pilot study conducted by Teissmann et al in 2014; study protocols of Rabau et al. in 2015 and Shekhawat et al. in 2015; and an experimental study by Lee et al. in 2017. Results were indicative of a superior efficacy of combined electrical and acoustic approaches, while large-scale controlled studies have not been performed. The need for extension and replication of these approaches is therefore timely.

The aim behind our proposed approach, similar to the bimodal approaches above, is to couple the effects of tRNS and acoustic stimulation (AS) for better temporary tinnitus suppression and possible reversal of maladaptive neuroplasticity related to tinnitus. We aim at targeting the (bilateral) auditory cortex with tRNS as in former studies and combine it with white noise (WN) stimulation. This specific combination is novel in its nature and is building on cortical excitability following tRNS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male and female patients 18 years to 75 years of age

• Persistent chronic tinnitus with duration of more than 3 months

• Signed Informed Consent after being informed about the study

• Fluent in German

• Tinnitus with a THI Grade 2 to 4 (18-76 points)

• Willing and able to attend the study visits

Exclusion Criteria:

• Actual neurological or psychiatric disorders

• Hyperacusis

• Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics)

• Implanted pacemaker

• Surgical implants in the head region, such as cochlea implants

• Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss > 40dB in any measured frequency up to 2kHz

• Women who are pregnant or breast feeding

• Intention to become pregnant during the course of the study

• Known or suspected non-compliance, drug or alcohol abuse

• Participation in another study with investigational drug within the 30 days preceding and during the present study,

• Enrolment of the investigator, his/her family members, employees and other dependent persons

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Other:
• transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions, parallel to the application of AS with WN 15 dB above the individual MML in one study arm. TRNS will be applied using two electrodes (35 qcm, 0,9% saline -soaked). Stimulus intensity will be below individual sensation threshold, but max. 2 mA. AS will never surpass 85 dB SPL at the ears.
• transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, University Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3. — View Citation

Claes L, Stamberger H, Van de Heyning P, De Ridder D, Vanneste S. Auditory cortex tACS and tRNS for tinnitus: single versus multiple sessions. Neural Plast. 2014;2014:436713. doi: 10.1155/2014/436713. Epub 2014 Dec 22. — View Citation

Joos K, De Ridder D, Vanneste S. The differential effect of low- versus high-frequency random noise stimulation in the treatment of tinnitus. Exp Brain Res. 2015 May;233(5):1433-40. doi: 10.1007/s00221-015-4217-9. Epub 2015 Feb 19. — View Citation

Kreuzer PM, Poeppl TB, Rupprecht R, Vielsmeier V, Lehner A, Langguth B, Schecklmann M. Daily high-frequency transcranial random noise stimulation of bilateral temporal cortex in chronic tinnitus - a pilot study. Sci Rep. 2019 Aug 22;9(1):12274. doi: 10.1038/s41598-019-48686-0. — View Citation

Lee HY, Choi MS, Chang DS, Cho CS. Combined Bifrontal Transcranial Direct Current Stimulation and Tailor-Made Notched Music Training in Chronic Tinnitus. J Audiol Otol. 2017 Apr;21(1):22-27. doi: 10.7874/jao.2017.21.1.22. Epub 2017 Mar 30. — View Citation

Mohsen S, Mahmoudian S, Talebian S, Pourbakht A. Prefrontal and auditory tRNS in sequence for treating chronic tinnitus: a modified multisite protocol. Brain Stimul. 2018 Sep-Oct;11(5):1177-1179. doi: 10.1016/j.brs.2018.04.018. Epub 2018 Apr 25. No abstract available. — View Citation

Rabau S, Van Rompaey V, Van de Heyning P. The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial. Trials. 2015 Nov 10;16:514. doi: 10.1186/s13063-015-1041-2. — View Citation

Shekhawat GS, Kobayashi K, Searchfield GD. Methodology for studying the transient effects of transcranial direct current stimulation combined with auditory residual inhibition on tinnitus. J Neurosci Methods. 2015 Jan 15;239:28-33. doi: 10.1016/j.jneumeth.2014.09.025. Epub 2014 Oct 5. — View Citation

Teismann H, Wollbrink A, Okamoto H, Schlaug G, Rudack C, Pantev C. Combining transcranial direct current stimulation and tailor-made notched music training to decrease tinnitus-related distress--a pilot study. PLoS One. 2014 Feb 25;9(2):e89904. doi: 10.1371/journal.pone.0089904. eCollection 2014. — View Citation

Van Doren J, Langguth B, Schecklmann M. Electroencephalographic effects of transcranial random noise stimulation in the auditory cortex. Brain Stimul. 2014 Nov-Dec;7(6):807-12. doi: 10.1016/j.brs.2014.08.007. Epub 2014 Aug 26. — View Citation

Vanneste S, Fregni F, De Ridder D. Head-to-Head Comparison of Transcranial Random Noise Stimulation, Transcranial AC Stimulation, and Transcranial DC Stimulation for Tinnitus. Front Psychiatry. 2013 Dec 18;4:158. doi: 10.3389/fpsyt.2013.00158. eCollection 2013. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of self-report Visual Analogue Scale (VAS) ratings on tinnitus severity (loudness, distress)	Minmum value = 1, maximum value =10. The higher scores means a worse outcome.	up to 6 months
Primary	Change of minimum masking level (MML)		up to 6 months
Secondary	event-related EEG power in alpha band	The influence of simultaneous tRNS and AS stimulation on neurophysiology will be investigated as a secondary outcome. Resting state and event-related EEG (auditory oddball) (Attias et al., 1993) will be recorded for that purpose.	up to 6 months