AzTrials
AzTrials

Chronic TinnitusMultisite rTMSNCT01663324

rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network

A study testing rTMS intervention 1 and rTMS intervention 2 in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.

Completed

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

Official record
Search all trials

Trial summary

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Tinnitus
What is being tested?
rTMS intervention 1 and rTMS intervention 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGermany
Study dates
Jul 2012to Jan 2015
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosis of subjective chronic tinnitus
  • THI > 38
  • Duration of tinnitus more than 6 months

Who cannot join

  • Objective tinnitus
  • Treatable cause of the tinnitus
  • Involvement in other treatments for tinnitus at the same time
  • Clinically relevant psychiatric comorbidity
  • Clinically relevant unstable internal or neurological comorbidity
  • History of or evidence of significant brain malformation or neoplasm, head injury
Show all 12Show fewer
  • 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
  • Prior treatment with TMS

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Regensburg- Dept of Psychiatry

    Regensburg, 93053

Other trials in Germany

About this study

Official title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.

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. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Being tested
rTMS intervention 1, rTMS intervention 2
Keywords
Tinnitus, chronic subjective Tinnitus, transcranial magnetic stimulation, rTMS, hearing disorders
Medical subject headings
Tinnitus, Hearing Disorders

What participants receive

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

  • rTMS intervention 1Device

    Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.

    Arms: single site rTMS

  • rTMS intervention 2Device

    Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold).

    Arms: multisite rTMS

Study groups in NCT01663324
Study groupRoleWhat they receive
single site rTMSExperimentalLow frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1
Receives: Device: rTMS intervention 1
multisite rTMSExperimentalCombined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2
Receives: Device: rTMS intervention 2

What is being measured

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

  1. Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)

    Measured: Day 12

  2. Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)

    Measured: Day 12

Secondary outcomes (16)

  1. Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

    Measured: Day 12

  2. Change in quality of life as measured by the WHOQoL

    Measured: Day 12

  3. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Measured: Day 12

  4. Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)

    Measured: Day 90

  5. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Measured: Day 12

  6. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Measured: Day 90

  7. Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale

    Measured: Day 180

  8. Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

    Measured: Day 180

  9. Change of depressive symptoms as measured by the Major Depression Inventory (MDI)

    Measured: Day 90

  10. Change in quality of life as measured by the WHOQoL

    Measured: Day 90

  11. Change in quality of life as measured by the WHOQoL

    Measured: Day 180

  12. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Measured: Day 90

  13. Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"

    Measured: Day 180

  14. Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)

    Measured: Day 180

  15. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

    Measured: Day 90

  16. Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller

    Measured: Day 180

Timeline

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

  1. First posted13 Aug 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionAug 2014
  4. Study completionJan 2015

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01663324
Sponsor's protocol ID
Uni-Reg-multisite-rTMS-Tin-01
Acronym
Multisite rTMS
Status last verified
May 2016
First submitted
23 Jul 2012
Last updated
18 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Lehner A, Schecklmann M, Greenlee MW, Rupprecht R, Langguth B. Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial. Sci Rep. 2016 Mar 1;6:22302. doi: 10.1038/srep22302.

    PubMed 26927363

  • Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269.

    PubMed 23968498

Questions about this trial

What is this clinical trial studying?

A study testing rTMS intervention 1 and rTMS intervention 2 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 3 inclusion and 12 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 18 May 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 (TQ reduction ≥5, contrast baseline versus day 12) (time frame: Day 12). 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 NCT01663324, which also lists 2 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 18 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in