An interventional study of tDCS and sound therapy in Tinnitus and Acute, sponsored by Newcastle University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Newcastle University · Not applicable, Interventional, and Treatment
Tinnitus is a common condition, in which people hear continuous sounds in the absence of an external source producing those sounds. Most people experience tinnitus for short periods of time throughout their life, for instance after exposure to loud noise, and some people experience long-term tinnitus. In most cases of tinnitus, there is a degree of hearing loss (often only mild), but it is rare for tinnitus to represent any serious disorder of the brain or ear. There are no widely effective treatments for tinnitus to reduce its loudness or eliminate it, but the majority of people with long-term tinnitus lead a normal life, without any impairment in quality of life on account of the tinnitus. A minority of people with long-term tinnitus experience distress as a result of it, and most people with long-term tinnitus gradually get used to the sound, and notice it less and less over time.
Previous studies have shown that applying a weak electrical current to the scalp (electrical stimulation) can lead to a small reduction in the loudness and impact of tinnitus for some people who have had tinnitus for many months or years already, and that this is significantly more effective, on average, than applying placebo (i.e. pretend) electrical stimulation. Electrical stimulation has never been tested in people who have recently developed their tinnitus.
Certain specific sounds, tailored to individuals' tinnitus, can significantly quieten tinnitus for some people, when these are listened to for an hour or so each day for weeks or months. However, the average quieting effect is quite modest. Like with electrical stimulation, these have only been tested by people with tinnitus already present for months to years.
Aims of study
The researchers believe that electrical stimulation and tailored sounds may be more effective in quieting tinnitus when given early in the course of tinnitus, compared to later on. Many researchers also believe that combining different types of tinnitus treatment may have a stronger effect than the sum of the effects of each individually.
Finally, the researchers want to test whether using interventions to quieten tinnitus early on in its course, even just for one month, might have a long-lasting or permanent effect in reducing tinnitus symptoms.
The benefits of treating tinnitus early, and using combination interventions, are currently theoretical, and one main aim of the study is to test whether they do exist.
The other main aim is to see how acceptable people find the course of combined intervention in the time period shortly after their tinnitus begins.
The volunteers are being approached because the volunteers have indicated that they have newly developed tinnitus.
What taking part involves
If they take part in the study, they will attend the researcher's laboratory on a total of 10 sessions over one month, to do the following:
The first session may take up to 2 hours, and other sessions last around 1 hour each. The exact timing of the sessions can be negotiated with the research team to suit their schedule as far as possible. Weekday, evening and weekend appointments are all possible.
Separately to these sessions, we provide a copy of their personalised sound files to take home, and encourage you to listen to these for up to 60 minutes per day.
We will also contact them 6 months after the onset of their tinnitus to ask for them to report their current tinnitus symptoms, in the form of a questionnaire. This can be completed online, and does not require another visit.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Newcastle University is the lead sponsor of 60 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In addition to these criteria, the researcher might have other reasons to suspect that participation is either , or might be unsuitable. In such cases, the researcher should discuss these concerns with the potential participant and/or a senior member of the research team. Participation should only proceed if all those involved in these discussions agree it should.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
would present active tDCS and sound therapy for 40 minutes
Device: tDCS · Device: sound therapy
would provide a sham tDCS and sound therapy
Device: tDCS · Device: sound therapy
would provide direct current for 40 minutes in 20 minute interval at 2 mA
Also known as: transcranial direct current stimulation
would provide acoustic ripples along with tDCS
Numerical Rating Scale
Primary outcome will be perceived tinnitus loudness assessed using a self-reported Numerical Rating Scale (NRS), where participants rate the loudness of their tinnitus on a scale from 0 to 10. Higher scores indicate greater perceived loudness. The NRS will be administered at baseline and post-intervention to evaluate changes in subjective tinnitus loudness.
Time frame: 6 months for each participant
Tinnitus Distress using Tinnitus Handicap Inventory
Tinnitus-related distress will be assessed using the Tinnitus Handicap Inventory (THI), a 25-item self-report questionnaire measuring the emotional, functional, and catastrophic impact of tinnitus. Higher scores indicate greater perceived handicap. The THI will be administered at baseline and post-intervention to evaluate changes in tinnitus-related distress.
Time frame: 6 months
Tinnitus distress using Tinnitus Functional Index
Tinnitus-related functional impact will be measured using the Tinnitus Functional Index (TFI), a validated 25-item questionnaire assessing tinnitus severity across eight subscales including sleep, emotional distress, and concentration. Higher scores reflect greater tinnitus-related burden. The TFI will be completed at baseline and post-intervention to assess changes in tinnitus-related impact.
Time frame: 6 months
Changes in tinnitus loudness
In addition to self-reported tinnitus distress, tinnitus loudness will be assessed using audiometric loudness matching, where participants adjust the intensity of a pure tone or narrowband noise presented to the ear ipsilateral to the tinnitus until it matches the perceived loudness of their tinnitus. The matched level will be recorded in decibels sensation level (dB SL), with measurements taken at baseline and post-intervention to evaluate changes in perceived loudness.
Time frame: 6 months
Changes in source localized power and resting state functional connectivity
Exploratory measures will comprise resting-state electroencephalography (EEG) before and after the course of treatment, which will be analysed exploratively in terms of source-localised power and connectivity to indicate predictors of treatment success, correlates of treatment, and correlates of treatment success. 64-channel resting-state EEG data will be preprocessed in EEGlab, and transformed into source-level power and connectivity using the sLORETA toolbox. The following comparisons will be made using two-samples T tests or linear regression analyses with multiple comparisons correction:
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Yes — Raw datas including participant's numerical rating scales, tinnitus questionnaires, and tinnitus pitch and loudness
Supporting information: Study protocol
Time frame: Tentative from march 2027
Access criteria: Access to raw data and study protocols
Start is estimated for Aug 2025; primary completion for Dec 2026, 16 months later.
Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 16 months is close to that.
Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Newcastle University