Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

NCT07885176 | Recruiting

• 1 other identifier: 26-4807_1-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.

Conditions

Tinnitus; Tinnitus, Bilateral

Keywords

Tinnitus; DeepTMS

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks

• Tinnitus loudness

  12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks

• Clinical Global Inventory - Improvement Scale

  end of treatment after two weeks, plus Follow Up after 10 weeks

• Mini-Tinnitus Questionnaire (Mini-TQ)

  12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks

• Major Depression Inventory (MDI)

  12 weeks: from enrollment to end of treatment after 2 weeks, plus Follow Up after 10 weeks

Study Arms (3)

H1-coil

EXPERIMENTAL

18 Hz, 2000 pulses

Device: DeepTms

H4-coil

EXPERIMENTAL

1 Hz, 2000 pulses

Device: DeepTms

H7-coil

SHAM COMPARATOR

18 Hz, 2000 pulses placebo

Device: DeepTms

Interventions

DeepTms DEVICE

2 weeks deepTMS with different H-coils, 2000 pulses per session, Follow Up 10 weeks after treatment end

H1-coil; H4-coil; H7-coil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic tinnitus (\> 6 months)
• Moderate tinnitus burden-corresponding to a score of ≥ 18 on the Tinnitus Handicap Inventory
• Stable medication regimen with psychoactive substances

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

Psychiatry and Psychotherapy, Center of Neuromodulation / TMS, University Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 24685051 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Schoisswohl, Prof. Dr. hum sc

  Psychiatry and Psychotherapie University Regensburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Schoisswohl, Prof. Dr.

CONTACT

+49 941 941 1284; stefan.schoisswohl@ukr.de

Susanne Staudinger, M.A.

CONTACT

+49 941 941 2096; susanne.staudinger@medbo.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Randomized, placebo-controlled, parallel-group study with three treatment arms; additional comparison with a historical rTMS control group.

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 21, 2026
• Study Start: September 19, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)