Chronic TinnitustRNS-tinNCT01965028
Daily Bi-temporal Transcranial Random Noise Stimulation in Tinnitus
A study testing Transcranial random noise stimulation (tRNS) in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
Trial summary
Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Tinnitus
- What is being tested?
- Transcranial random noise stimulation (tRNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jan 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bothersome, subjective chronic tinnitus
- Diagnosis: Duration of tinnitus more than 6 months
Who cannot join
- Objective tinnitus
- Irregular head shap below the electrodes
- Eczema on the head
- Treatable cause of the tinnitus
- Involvement in other treatments for tinnitus at the same time
- Clinically relevant psychiatric comorbidity
Show all 13Show fewer
- Clinically relevant unstable internal or neurological comorbidity
- History of or evidence of significant brain malformation or neoplasm, head injury
- Cerebral vascular events
- Neurodegenerative disorder affecting the brain or prior brain surgery
- Metal objects in and around body that can not be removed
- Pregnancy
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
Read the detailed description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.
- Conditions
- Chronic Tinnitus
- Being tested
- Transcranial random noise stimulation (tRNS)
- Keywords
- tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial random noise stimulation (tRNS)Device
High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS
| Study group | Role | What they receive |
|---|---|---|
| Transcranial random noise stimulation (tRNS) | Experimental | High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Receives: Device: Transcranial random noise stimulation (tRNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
Measured: Week 12
Secondary outcomes (12)
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Measured: Week 2
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Measured: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Measured: Week 12
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Measured: Week 2
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Measured: Week 4
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Measured: Week 12
Change of depressive symptoms as measured by the Major Depression Inventory
Measured: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory
Measured: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory
Measured: Week 12
Change in quality of life as measured by the WHOQoL-Bref
Measured: Week 2
Change in quality of life as measured by the WHOQoL-Bref
Measured: Week 4
Change in quality of life as measured by the WHOQoL-Bref
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, MD, Ph.D., Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965028
- Sponsor's protocol ID
- Uni-Reg-tRNS01
- Acronym
- tRNS-tin
- Status last verified
- Mar 2016
- First submitted
- 14 Oct 2013
- Last updated
- 7 Mar 2016
- Results posted
- No
Publications
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.
PubMed 31439873
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Daily Bi-temporal Transcranial Random Noise Stimulation in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT01965028
- Acronym / sponsor ID
- tRNS-tin / Uni-Reg-tRNS01
- Conditions
- Chronic Tinnitus
- Keywords
- tinnitus, transcranial random noise stimulation, tRNS, auditory cortex, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stimulation of the left and right auditory cortex with daily transcranial random noise stimulation (tRNS) is used to modulate the neural pathways involved in chronic tinnitus.
Detailed description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. These changes are represented by hyper-activity and hyper-synchronicity in the auditory pathway. Treatment remains difficult. Non-invasive brain stimulation methods has shown to be effective in the treatment of chronic tinnitus with moderate effect size. Preliminary data presented on international conferences suggest the use of transcranial random noise stimulation (tRNS) over both auditory cortices as new and highly effective treatment. High-frequency (hf; 100-650Hz) tRNS might be highly effective in tackling hyper-synchronised cell assemblies. Daily Hf-tRNS (2 weeks) will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in an one-arm pilot trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial random noise stimulation (tRNS) | Experimental | Device: Transcranial random noise stimulation (tRNS)High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of bothersome, subjective chronic tinnitus
- Diagnosis: Duration of tinnitus more than 6 months
Key exclusion criteria (13 listed)
- Objective tinnitus
- Irregular head shap below the electrodes
- Eczema on the head
- Treatable cause of the tinnitus
- Involvement in other treatments for tinnitus at the same time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial random noise stimulation (tRNS)High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS | Device | Transcranial random noise stimulation (tRNS) |
Primary outcome
Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12)
Time frame: Week 12
12 secondary outcomes
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time frame: Week 2
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionnaire
Time frame: Week 12
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time frame: Week 2
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Numeric Rating Scales
Time frame: Week 12
Change of depressive symptoms as measured by the Major Depression Inventory
Time frame: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory
Time frame: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory
Time frame: Week 12
Change in quality of life as measured by the WHOQoL-Bref
Time frame: Week 2
Change in quality of life as measured by the WHOQoL-Bref
Time frame: Week 4
Change in quality of life as measured by the WHOQoL-Bref
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Derived from this study: PubMed 31439873Kreuzer 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.
Related trials for Chronic Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruitingPhase 1/2
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
Tinnitus, Bilateral, Cochlear Synaptopathy
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruiting
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, MD, Ph.D. principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial random noise stimulation (tRNS) in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
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 2 inclusion and 13 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 7 Mar 2016. 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 Germany. 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. 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?
Number of treatment responders (response: Tinnitus Questionnaire total score reduction ≥ 5, contrast baseline versus end of treatment/week 12) (time frame: Week 12). 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 NCT01965028, which also lists 1 linked publication.
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 7 Mar 2016.