TinnitusNCT01929837
Tinnitus rTMS 2013
A study testing E-fied navigated rTMS, non-navigated rTMS and Navigated rTMS in people with Tinnitus, run by Turku University Hospital at 1 site in Finland.
Trial summary
Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- E-fied navigated rTMS, non-navigated rTMS and Navigated rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2013to Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic tinnitus 6 months-10 years
- age 18-65 years
- tinnitus intensity VAS at least 4/10
Who cannot join
- pulsatile tinnitus
- objective tinnitus
- epilepsy, brain disease
- severe/recent heart disease
- pregnancy
- alcohol abuse
- metallic implants etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Tinnitus With Transcranial Magnetic Stimulation
Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. Pathophysiology of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies
- Conditions
- Tinnitus
- Being tested
- E-fied navigated rTMS, non-navigated rTMS, sham E-field navigated rTMS, Navigated rTMS
- Keywords
- Tinnitus, Transcranial magnetic stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-fied navigated rTMSDevice
1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus
non-navigated rTMSDevice
1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations)
sham E-field navigated rTMSDevice
Navigated rTMSDevice
1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)
| Study group | Role | What they receive |
|---|---|---|
| E-fied navigated rTMS | Experimental | Electrical field navigated transcranial magnetic stimulation Receives: Device: E-fied navigated rTMS |
| sham E-field navigated rTMS | Sham comparator | Sham electrical field navigated rTMS Receives: Device: sham E-field navigated rTMS |
| non-navigated rTMS | Experimental | non-navigated rTMS Receives: Device: non-navigated rTMS |
| Experimental, Navigated rTMS | Experimental | Navigated rTMS, Receives: Device: Navigated rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary
Measured: Change from baseline and 2-3 days after treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2016
- Study completionAug 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 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Satakunta Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929837
- Sponsor's protocol ID
- T69/2013
- Status last verified
- Aug 2016
- First submitted
- 24 Jun 2013
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sahlsten H, Taiminen T, Karukivi M, Sjosten N, Nikkila J, Virtanen J, Paavola J, Joutsa J, Niinivirta-Joutsa K, Takala M, Holm A, Rauhala E, Loyttyniemi E, Johansson R, Jaaskelainen SK. Psychiatric (Axis I) and personality (Axis II) disorders and subjective psychiatric symptoms in chronic tinnitus. Int J Audiol. 2018 Apr;57(4):302-312. doi: 10.1080/14992027.2017.1409440. Epub 2017 Nov 30.
PubMed 29188734
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tinnitus With Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT01929837
- Acronym / sponsor ID
- T69/2013
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Satakunta Central Hospital
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Aug 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.
Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. Pathophysiology of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E-fied navigated rTMS | Experimental | Device: E-fied navigated rTMSElectrical field navigated transcranial magnetic stimulation |
| sham E-field navigated rTMS | Sham comparator | Device: sham E-field navigated rTMSSham electrical field navigated rTMS |
| non-navigated rTMS | Experimental | Device: non-navigated rTMSnon-navigated rTMS |
| Experimental, Navigated rTMS | Experimental | Device: Navigated rTMSNavigated rTMS, |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic tinnitus 6 months-10 years
- age 18-65 years
- tinnitus intensity VAS at least 4/10
Key exclusion criteria (7 listed)
- pulsatile tinnitus
- objective tinnitus
- epilepsy, brain disease
- severe/recent heart disease
- pregnancy
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 |
|---|---|---|
| E-fied navigated rTMS1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus | Device | E-fied navigated rTMS |
| non-navigated rTMS1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations) | Device | non-navigated rTMS |
| sham E-field navigated rTMS | Device | sham E-field navigated rTMS |
| Navigated rTMS1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor) | Device | Experimental, Navigated rTMS |
Primary outcome
The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary
Time frame: Change from baseline and 2-3 days after treatment period
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 31 Aug 2016.
- Derived from this study: PubMed 29188734Sahlsten H, Taiminen T, Karukivi M, Sjosten N, Nikkila J, Virtanen J, Paavola J, Joutsa J, Niinivirta-Joutsa K, Takala M, Holm A, Rauhala E, Loyttyniemi E, Johansson R, Jaaskelainen SK. Psychiatric (Axis I) and personality (Axis II) disorders and subjective psychiatric symptoms in chronic tinnitus. Int J Audiol. 2018 Apr;57(4):302-312. doi: 10.1080/14992027.2017.1409440. Epub 2017 Nov 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-fied navigated rTMS, non-navigated rTMS and Navigated rTMS in people with Tinnitus, run by Turku University Hospital at 1 site in Finland.
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 7 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 31 Aug 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 Finland. 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. Some participants in this study may receive a placebo. 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?
The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary (time frame: Change from baseline and 2-3 days after treatment period). 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 NCT01929837, 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 31 Aug 2016.