TinnitusNCT01261949
Combined Low Frequency Frontal and Temporal rTMS Treatment in Chronic Tinnitus
A study testing Combined frontal and temporal rTMS and Temporal low frequency rTMS in people with Tinnitus, run by University of Regensburg at 1 site in Germany.
Trial summary
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Combined frontal and temporal rTMS and Temporal low frequency rTMS
- 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
- Apr 2009to Dec 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of subjective chronic tinnitus
- Duration of tinnitus more than 3 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, Bavaria
About this study
Official title: Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.
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 is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
- Conditions
- Tinnitus
- Being tested
- Combined frontal and temporal rTMS, Temporal low frequency rTMS
- Keywords
- Tinnitus, chronic subjective tinnitus, transcranial magnetic stimulation, sensation disorders, hearing disorders
- Medical subject headings
- Tinnitus, Sensation Disorders, Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined frontal and temporal rTMSDevice
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
Temporal low frequency rTMSDevice
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
| Study group | Role | What they receive |
|---|---|---|
| Combined frontal and temporal rTMS | Experimental | Combined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC Receives: Device: Combined frontal and temporal rTMS |
| Temporal low frequency rTMS | Experimental | temporal low frequency rTMS of auditory cortex Receives: Device: Temporal low frequency rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Measured: Baseline, Day 12
Secondary outcomes (3)
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Measured: Baseline vs. all follow-up visits
Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)
Measured: Baseline vs. all follow-up visits
Change in quality of life as measured by the WHOQoL
Measured: Baseline vs. all follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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, Principal investigator, University of Regensburg - Dep. of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261949
- Sponsor's protocol ID
- Uni-Reg-rTMS-Tinnitus-02
- Status last verified
- Jan 2016
- First submitted
- 16 Dec 2010
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.
PubMed 22069382
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT01261949
- Acronym / sponsor ID
- Uni-Reg-rTMS-Tinnitus-02
- Conditions
- Tinnitus
- Keywords
- Tinnitus, chronic subjective tinnitus, transcranial magnetic stimulation, sensation disorders, hearing disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Dec 2010 (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.
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.
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 is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined frontal and temporal rTMS | Experimental | Device: Combined frontal and temporal rTMSCombined low frequency frontal and temporal transcranial magnetic stimulation of auditory cortex and right DLPFC |
| Temporal low frequency rTMS | Experimental | Device: Temporal low frequency rTMStemporal low frequency rTMS of auditory cortex |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of subjective chronic tinnitus
- Duration of tinnitus more than 3 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 |
|---|---|---|
| Combined frontal and temporal rTMSExperimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold) | Device | Combined frontal and temporal rTMS |
| Temporal low frequency rTMSExperimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold) | Device | Temporal low frequency rTMS |
Primary outcome
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller
Time frame: Baseline, Day 12
3 secondary outcomes
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12
Time frame: Baseline vs. all follow-up visits
Change of depressive symptoms as measured by the Beck Depression Inventory (BDI)
Time frame: Baseline vs. all follow-up visits
Change in quality of life as measured by the WHOQoL
Time frame: Baseline vs. all follow-up visits
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 8 Jan 2016.
- Results publication: PubMed 22069382Kreuzer PM, Landgrebe M, Schecklmann M, Poeppl TB, Vielsmeier V, Hajak G, Kleinjung T, Langguth B. Can Temporal Repetitive Transcranial Magnetic Stimulation be Enhanced by Targeting Affective Components of Tinnitus with Frontal rTMS? A Randomized Controlled Pilot Trial. Front Syst Neurosci. 2011 Nov 4;5:88. doi: 10.3389/fnsys.2011.00088. eCollection 2011.
- Tinnitus Research and Treatment Center at the University of RegensburgLink provided by the sponsor.
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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 principal investigator
University of Regensburg - Dep. 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 Combined frontal and temporal rTMS and Temporal low frequency rTMS in people with 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 8 Jan 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?
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller (time frame: Baseline, Day 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 NCT01261949, 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 8 Jan 2016.