TinnitusdeepTMSNCT07885176
Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
A study testing DeepTms in people with Tinnitus and Tinnitus, Bilateral, run by University of Regensburg at 1 site in Germany.
Trial summary
Study of the efficacy of different H-coils in chronic tinnitus. Hypothesis: Active Deep repetitive transcranial magnetic stimulation deeprTMS reduces tinnitus distress more effectively than placebo stimulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus, Tinnitus, Bilateral
- What is being tested?
- DeepTms
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 19 Sep 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic tinnitus (> 6 months)
- Moderate tinnitus burden-corresponding to a score of ≥ 18 on the Tinnitus Handicap Inventory
- Stable medication regimen with psychoactive substances
Who cannot join
- Objective tinnitus
- Severe and unstable internal medicine, neurological, and psychiatric comorbidities (particularly acute psychosis, severe depression, or substance dependence; epilepsy; brain tumor; encephalitis; history of traumatic brain injury)
- Presence of contraindications for TMS (electrical implants or metallic objects in the body, such as a pacemaker or insulin pump)
- Currently undergoing or planning to undergo tinnitus treatment during the study
- Meniere's disease, otosclerosis, acoustic neuroma, or other clear-cut or treatment-requiring causes of tinnitus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Psychiatry and Psychotherapy, Center of Neuromodulation / TMS, University Regensburg
Regensburg, Bavaria, 93053
Susanne Staudinger, M.A., +49 941 941 2096, susanne.staudinger@medbo.de
Area Hofmann, +49 941 941 2098, area.hofmann@medbo.de
About this study
Study of the efficacy of different H-coils in chronic tinnitus. Hypothesis: Active Deep repetitive transcranial magnetic stimulation deeprTMS reduces tinnitus distress more effectively than placebo stimulation.
Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.
Read the detailed description
A two-week treatment study is planned to investigate the effectiveness of different deepTMS coils in the treatment of tinnitus. The study plans to enroll 60 patients with chronic subjective tinnitus. Recruitment will take place primarily through the affiliated interdisciplinary Tinnitus Center in Regensburg, as well as through posters or flyers at private practice physicians' offices and hearing aid specialists. After successful screening, standard audiological measurements (hearing threshold, tinnitus matching, etc.) and verification of the inclusion and exclusion criteria, study participants will be randomized into one of three treatment groups, each consisting of 20 patients: (1) 18 Hz deepTMS with the H1 coil; (2) 1 Hz deepTMS with the H4 coil; (3) 18 Hz placebo deepTMS with the H7 coil.
Two groups receive active deepTMS treatment, while the third group receives a placebo stimulation. The RCT version of the BrainsWay H7 coil is used for the placebo treatment. The placebo coil is integrated into the same stimulation helmet as the active treatment coil. The placebo stimulation generates acoustic and somatosensory stimuli comparable to those of the active stimulation but does not induce an electric field strong enough for therapeutic cortical stimulation.
The study plans to compare the H1 coil with the H4 coil. Furthermore, the treatment effects will be compared with a placebo treatment as well as with a matched historical control group of patients who were treated with conventional left temporal low-frequency rTMS at the Center for Neuromodulation at the University of Regensburg. The treatment phase corresponds to a standard rTMS treatment for tinnitus and consists of 10 weekday stimulation sessions over two weeks, with 2,000 pulses per session. Before treatment begins, each patient's individual resting motor threshold (RMT) is determined; this is used to set the stimulation intensity for the treatment. The stimulation intensity is gradually increased over the course of the first three treatment sessions from 100% to a maximum of 120% of the RMT. If the stimulation is perceived by the patients as too unpleasant or painful, the intensity is not increased further; treatment continues at the intensity level individually tolerated by each patient. Before and after the 2-week treatment period, patients are given several standardized tinnitus and health questionnaires, and standard audiological measurements are performed. In addition, a follow-up visit is scheduled ten weeks after the end of treatment to assess any potential lasting effects of the treatment. The following questionnaires are used:
- The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ)
- Tinnitus Sample Case History Questionnaire (TSCHQ)
- Tinnitus Handicap Inventory (THI)
- Tinnitus Functional Index (TFI)
- Mini Tinnitus Questionnaire (mini-TQ)
- Tinnitus Analogscales
- Major Depression Inventory (MDI )
- WHO-Quality of Life (WHOQoL-BREF)
- Clinical Global Impression Scale - Improvement (CGI-I) The primary endpoint is defined as the change in the Tinnitus Handicap Inventory (THI) from baseline (before treatment begins) to the end of treatment, as well as a comparison of this change between the treatment groups. Participants are also asked to rate the loudness of their tinnitus before and after active or placebo stimulation, respectively, in order to assess short-term changes in tinnitus perception. Patients in the placebo group will be given the opportunity to receive active treatment after the study is completed. This consists of a 10-day treatment course with 2,000 pulses per session using the H7 coil and an 18 Hz protocol.
There are no plans to calculate the required sample size, as only a single-case trial using deepTMS for tinnitus has been conducted to date. In addition, different coil geometries are used compared to conventional TMS studies. Therefore, it is difficult to estimate the potential effect size.
- Conditions
- Tinnitus, Tinnitus, Bilateral
- Being tested
- DeepTms
- Keywords
- Tinnitus, DeepTMS
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeepTmsDevice
2 weeks deepTMS with different H-coils, 2000 pulses per session, Follow Up 10 weeks after treatment end
| Study group | Role | What they receive |
|---|---|---|
| H1-coil | Experimental | 18 Hz, 2000 pulses Receives: Device: DeepTms |
| H4-coil | Experimental | 1 Hz, 2000 pulses Receives: Device: DeepTms |
| H7-coil | Sham comparator | 18 Hz, 2000 pulses placebo Receives: Device: DeepTms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Tinnitus Burden
Changes in Tinnitus Burden Measured Using the Tinnitus Handicap Inventory (THI) from Baseline to the End of Treatment, Including Group Comparisons.
The THI consists of 25 items designed to evaluate the perceived impact of tinnitus on an individual's daily life. Each item provides three response options: 'No', 'Sometimes' and 'Yes', which are scored as 0, 2 and 4 points respectively. The total THI score is obtained by summing the scores of all items, resulting in a score that ranges from 0 to 100, with higher scores indicating greater perceived handicap due to tinnitus.
Measured: 12 weeks: from enrollment to the end of treatment after two weeks, plus Follow Up after 10 weeks
Secondary outcomes (7)
Tinnitus Functional Index (TFI)
Changes in TFI:
The TFI measures the functional impact of tinnitus and consists of 25 items. It includes 8 subscales: cognitive interference, auditory perceptual difficulties, intrusiveness, sleep disturbances, disturbances of relaxation, quality of life impairment, emotional distress, and reduced sense of control. The total score ranges from 0 and 100. A lower score indicates greater perceived distress due to tinnitus.
Measured: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Tinnitus loudness
short-term changes in tinnitus loudness, ranging from 0% to 200% (0%=no tinnitus perception, 50% = half of the usually perceived tinnitus loudness, 100% usually perceived tinnitus loudness, 200%=twice as loud as usually perceived tinnitus loudness
Measured: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Clinical Global Inventory - Improvement Scale
Within 1 question, patients are asked to rate the overall improvement of their tinnitus complaints compared to before the treatment has started on a 7-point Likert scale (1-"very much better," 2-"much better," 3-"minimally better," 4-"no change," 5-"minimally worse," 6-"much worse," 7-"very much worse").
Measured: end of treatment after two weeks, plus Follow Up after 10 weeks
Mini-Tinnitus Questionnaire (Mini-TQ)
The Mini-TQ is a validated, 12-item patient-reported outcome measure designed to assess tinnitus-related psychological distress and its impact on daily life. Each item is scored on a 3-point scale: true (2 points), partly true (1 point), or not true (0 points), yielding a total score of 0-24, with higher scores indicating greater tinnitus-related distress.
Measured: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Major Depression Inventory (MDI)
The MDI is a validated 10-item self-report questionnaire assessing depressive symptoms. Items are rated from 0 (at no time) to 5 (all the time). For items 8 and 10, the higher sub-item score is used. The total score ranges from 0-50, with higher scores indicating greater depressive symptom severity.
Measured: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Tinnitus Analogue Scales
Participants rate the loudness of their tinnitus (0-not at all loud; 10-extremely loud), the tinnitus-induced discomfort (0-no discomfort; 10-severe discomfort), annoyance (0-not at all annoying; 10-extremely annoying), unpleasantness (0-not at all unpleasant; 10-extremely unpleasant) as well as the possibility to ignore their tinnitus (0-very easy to ignore; 10-impossible to ignore) on a Visual Analog Scale (VAS).
Measured: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
World Health Organization-Quality of Life instrument (WHOQOL-BREF)
A 26-item validated, self-report questionnaire assessing quality of life across four domains: physical health (items 3, 4, 10, 15-18), psychological health (items 5-7, 11, 19, 26), social relationships (items 20-22), and environment (items 8, 9, 12-14, 23-25). Items 1 and 2 assess overall quality of life and general health, respectively.
Scoring: Items are rated on a 5-point scale (1-5). Domain scores are transformed to a 4-20 or 0-100 scale, with higher scores indicating better quality of life. Items 3, 4, and 26 are reverse-scored.
Measured: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start19 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
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
- Model description
- Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
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
- Stefan Schoisswohl, Prof. Dr. hum sc, Principal investigator, Psychiatry and Psychotherapie University Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885176
- Sponsor's protocol ID
- 26-4807_1-101
- Acronym
- deepTMS
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salviati M, Bersani FS, Calabria LF, Rapinesi C, Kotzalidis GD, Minichino A, Romano A, Moraschi M, Chiacchiararelli L, Bozzao A, Cianfrone G, Girardi P. Deep transcranial magnetic stimulation in a woman with chronic tinnitus: clinical and FMRI findings. Seeking relief from a symptom and finding vivid memories by serendipity. Brain Stimul. 2014 May-Jun;7(3):492-4. doi: 10.1016/j.brs.2014.02.005. Epub 2014 Feb 20. No abstract available.
PubMed 24685051
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT07885176
- Acronym / sponsor ID
- deepTMS / 26-4807_1-101
- Conditions
- Tinnitus, Tinnitus, Bilateral
- Keywords
- Tinnitus, DeepTMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 19 Sep 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 21 Oct 2026 (actual)
- 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.
Study of the efficacy of different H-coils in chronic tinnitus. Hypothesis: Active Deep repetitive transcranial magnetic stimulation deeprTMS reduces tinnitus distress more effectively than placebo stimulation.
Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.
Detailed description
A two-week treatment study is planned to investigate the effectiveness of different deepTMS coils in the treatment of tinnitus. The study plans to enroll 60 patients with chronic subjective tinnitus. Recruitment will take place primarily through the affiliated interdisciplinary Tinnitus Center in Regensburg, as well as through posters or flyers at private practice physicians' offices and hearing aid specialists. After successful screening, standard audiological measurements (hearing threshold, tinnitus matching, etc.) and verification of the inclusion and exclusion criteria, study participants will be randomized into one of three treatment groups, each consisting of 20 patients: (1) 18 Hz deepTMS with the H1 coil; (2) 1 Hz deepTMS with the H4 coil; (3) 18 Hz placebo deepTMS with the H7 coil.
Two groups receive active deepTMS treatment, while the third group receives a placebo stimulation. The RCT version of the BrainsWay H7 coil is used for the placebo treatment. The placebo coil is integrated into the same stimulation helmet as the active treatment coil. The placebo stimulation generates acoustic and somatosensory stimuli comparable to those of the active stimulation but does not induce an electric field strong enough for therapeutic cortical stimulation.
The study plans to compare the H1 coil with the H4 coil. Furthermore, the treatment effects will be compared with a placebo treatment as well as with a matched historical control group of patients who were treated with conventional left temporal low-frequency rTMS at the Center for Neuromodulation at the University of Regensburg. The treatment phase corresponds to a standard rTMS treatment for tinnitus and consists of 10 weekday stimulation sessions over two weeks, with 2,000 pulses per session. Before treatment begins, each patient's individual resting motor threshold (RMT) is determined; this is used to set the stimulation intensity for the treatment. The stimulation intensity is gradually increased over the course of the first three treatment sessions from 100% to a maximum of 120% of the RMT. If the stimulation is perceived by the patients as too unpleasant or painful, the intensity is not increased further; treatment continues at the intensity level individually tolerated by each patient. Before and after the 2-week treatment period, patients are given several standardized tinnitus and health questionnaires, and standard audiological measurements are performed. In addition, a follow-up visit is scheduled ten weeks after the end of treatment to assess any potential lasting effects of the treatment. The following questionnaires are used:
- The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ)
- Tinnitus Sample Case History Questionnaire (TSCHQ)
- Tinnitus Handicap Inventory (THI)
- Tinnitus Functional Index (TFI)
- Mini Tinnitus Questionnaire (mini-TQ)
- Tinnitus Analogscales
- Major Depression Inventory (MDI )
- WHO-Quality of Life (WHOQoL-BREF)
- Clinical Global Impression Scale - Improvement (CGI-I) The primary endpoint is defined as the change in the Tinnitus Handicap Inventory (THI) from baseline (before treatment begins) to the end of treatment, as well as a comparison of this change between the treatment groups. Participants are also asked to rate the loudness of their tinnitus before and after active or placebo stimulation, respectively, in order to assess short-term changes in tinnitus perception. Patients in the placebo group will be given the opportunity to receive active treatment after the study is completed. This consists of a 10-day treatment course with 2,000 pulses per session using the H7 coil and an 18 Hz protocol.
There are no plans to calculate the required sample size, as only a single-case trial using deepTMS for tinnitus has been conducted to date. In addition, different coil geometries are used compared to conventional TMS studies. Therefore, it is difficult to estimate the potential effect size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.
| Arm | Type | Receives |
|---|---|---|
| H1-coil | Experimental | Device: DeepTms18 Hz, 2000 pulses |
| H4-coil | Experimental | Device: DeepTms1 Hz, 2000 pulses |
| H7-coil | Sham comparator | Device: DeepTms18 Hz, 2000 pulses placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic tinnitus (> 6 months)
- Moderate tinnitus burden-corresponding to a score of ≥ 18 on the Tinnitus Handicap Inventory
- Stable medication regimen with psychoactive substances
Key exclusion criteria (5 listed)
- Objective tinnitus
- Severe and unstable internal medicine, neurological, and psychiatric comorbidities (particularly acute psychosis, severe depression, or substance dependence; epilepsy; brain tumor; encephalitis; history of traumatic brain injury)
- Presence of contraindications for TMS (electrical implants or metallic objects in the body, such as a pacemaker or insulin pump)
- Currently undergoing or planning to undergo tinnitus treatment during the study
- Meniere's disease, otosclerosis, acoustic neuroma, or other clear-cut or treatment-requiring causes of tinnitus
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 |
|---|---|---|
| DeepTms2 weeks deepTMS with different H-coils, 2000 pulses per session, Follow Up 10 weeks after treatment end | Device | H1-coil, H4-coil, H7-coil |
Primary outcome
Changes in Tinnitus Burden
Time frame: 12 weeks: from enrollment to the end of treatment after two weeks, plus Follow Up after 10 weeks
Changes in Tinnitus Burden Measured Using the Tinnitus Handicap Inventory (THI) from Baseline to the End of Treatment, Including Group Comparisons. The THI consists of 25 items designed to evaluate the perceived impact of tinnitus on an individual's daily life. Each item provides three response options: 'No', 'Sometimes' and 'Yes', which are scored as 0, 2 and 4 points respectively. The total THI score is obtained by summing the scores of all items, resulting in a score that ranges from 0 to 100, with higher scores indicating greater perceived handicap due to tinnitus.
7 secondary outcomes
Tinnitus Functional Index (TFI)
Time frame: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Tinnitus loudness
Time frame: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Clinical Global Inventory - Improvement Scale
Time frame: end of treatment after two weeks, plus Follow Up after 10 weeks
Mini-Tinnitus Questionnaire (Mini-TQ)
Time frame: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Major Depression Inventory (MDI)
Time frame: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Tinnitus Analogue Scales
Time frame: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
World Health Organization-Quality of Life instrument (WHOQOL-BREF)
Time frame: 12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 24685051Salviati M, Bersani FS, Calabria LF, Rapinesi C, Kotzalidis GD, Minichino A, Romano A, Moraschi M, Chiacchiararelli L, Bozzao A, Cianfrone G, Girardi P. Deep transcranial magnetic stimulation in a woman with chronic tinnitus: clinical and FMRI findings. Seeking relief from a symptom and finding vivid memories by serendipity. Brain Stimul. 2014 May-Jun;7(3):492-4. doi: 10.1016/j.brs.2014.02.005. Epub 2014 Feb 20. No abstract available.
- Individual participant dataSharing planned: No
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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.
Stefan Schoisswohl, Prof. Dr. hum sc principal investigator
Psychiatry and Psychotherapie University 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 DeepTms in people with Tinnitus and Tinnitus, Bilateral, 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 5 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Schoisswohl, Prof. Dr. (+49 941 941 1284, stefan.schoisswohl@ukr.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Tinnitus Burden (time frame: 12 weeks: from enrollment to the end of treatment after two weeks, plus Follow Up after 10 weeks). 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 NCT07885176, 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 21 Oct 2026.