Chronic TinnitusRELAXNCT01907022
Combined rTMS and Relaxation in Chronic Tinnitus
A study testing Left DLPFC Butterfly Coil in people with Chronic Tinnitus, run by University of Regensburg at 1 site in Germany.
Trial summary
Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds. 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?
- Left DLPFC Butterfly Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Oct 2014
- 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
- 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.
About this study
Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus
Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress 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. One significant modulator of tinnitus is stress. 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. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.
- Conditions
- Chronic Tinnitus
- Being tested
- Left DLPFC Butterfly Coil
- Keywords
- repetitive transcranial magnetic stimulation, chronic tinnitus, relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left DLPFC Butterfly CoilDevice
High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.
Arms: Left DLPFC Butterfly Coil
| Study group | Role | What they receive |
|---|---|---|
| Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil | Experimental | High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. Receives: Device: Left DLPFC Butterfly Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)
Measured: Week 12
Secondary outcomes (14)
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Measured: Week 4
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Measured: Week 4
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Measured: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Measured: Week 2
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Measured: Week 2
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Measured: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Measured: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Measured: Week 2
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
Measured: Week 2
Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)
Measured: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Measured: Week 12
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Measured: Week 12
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Measured: Week 12
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
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 posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 42 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 - Dept of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907022
- Sponsor's protocol ID
- Uni-Reg-Ti-CDC01-RELAX
- Acronym
- RELAX
- Status last verified
- Mar 2015
- First submitted
- 19 Jul 2013
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT01907022
- Acronym / sponsor ID
- RELAX / Uni-Reg-Ti-CDC01-RELAX
- Conditions
- Chronic Tinnitus
- Keywords
- repetitive transcranial magnetic stimulation, chronic tinnitus, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jul 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.
Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.
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. One significant modulator of tinnitus is stress. 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. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a 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 |
|---|---|---|
| Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil | Experimental | Device: Left DLPFC Butterfly CoilHigh frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. |
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
- Duration of tinnitus more than 6 months
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Left DLPFC Butterfly CoilHigh frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. Arms: Left DLPFC Butterfly Coil | Device | Left dorsolateral prefrontal cortex (DLPFC) Butterfly Coil |
Primary outcome
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)
Time frame: Week 12
14 secondary outcomes
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time frame: Week 2
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Week 2
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time frame: Week 2
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 4
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Week 2
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
Time frame: Week 2
Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)
Time frame: Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time frame: Week 12
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
Time frame: Week 12
Change of tinnitus severity as measured by the Tinnitus Severity Scale
Time frame: Week 12
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
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 12 Mar 2015.
Related trials for Chronic Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
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 - Dept of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left DLPFC Butterfly Coil 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 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 12 Mar 2015. 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 end of treatment) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2015.