Transcranial Electrical and Acoustic Stimulation for Tinnitus (tEAS)
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|ClinicalTrials.gov Identifier: NCT04551404|
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : November 28, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus Tinnitus, Subjective||Other: transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS) Other: transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)||Not Applicable|
|Study Type :||Interventional|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
The crossover within-person design with 2 groups, 2 active conditions and appropriate control/pseudo-placebo/sham session is double-blinded. Overall, participants will undergo 20 stimulation visits and 6 additional assessment visits.
Prior to conducting the above study, a pilot study of 40 patients and just 6 visits will be conducted to validate clinical procedures and outcomes. This procedure was approved by the ethics committee.
|Official Title:||Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||December 1, 2024|
Experimental: Study Intervention(s) A
TRNS bilateral temporal regions combined with AS for 20 minutes
Sham-tRNS bilateral temporal regions combined with Sham-AS for 20 minutes
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.
Experimental: Study Intervention(s) B = Control Intervention
TRNS bilateral temporal regions for 20 minutes
Sham-tRNS bilateral temporal regions for 20 minutes
Other: transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)
The study intervention consists of a bilateral tRNS application over temporal regions
- Change of self-report Visual Analogue Scale (VAS) ratings on tinnitus severity (loudness, distress) [ Time Frame: up to 6 months ]Minmum value = 1, maximum value =10. The higher scores means a worse outcome.
- Change of minimum masking level (MML) [ Time Frame: up to 6 months ]
- event-related EEG power in alpha band [ Time Frame: up to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551404