Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation (indiTMS)

• ClinicalTrials.gov Identifier: NCT03957122
• Recruitment Status: Terminated
• First Posted: May 21, 2019
• Last Update Posted: December 19, 2019
• Sponsor: University of Regensburg
• Information provided by (Responsible Party): Berthold Langguth, MD, Ph.D., University of Regensburg

Study Description

Brief Summary:

In the first visit a magnetic resonance imaging measurement will be done for the use of a neuronavigation System with the aim to control for stable coil position over the course of the trial. EEG positions CP5/CP6 will be used for positioning the coil. Two test sessions will examine the temporary reductions in tinnitus loudness after 1Hz, 10Hz, 20Hz and 0.1Hz rTMS as control condition over left and right temporo-parietal junction accompanied by electroencephalography. For the two-week treatment three arms will be evaluated: standard treatment (1Hz left-sided) in the groups with and without temporary reductions in test sessions and the best protocol as elicited in test sessions.

Condition or disease	Intervention/treatment	Phase
Tinnitus	Device: repetitive transcranial magnetic stimulation	Not Applicable

Detailed Description:

Efficacy of repetitive transcranial magnetic stimulation (rTMS) in chronic tinnitus is moderate. So far single sessions and daily treatment of rTMS were rarely combined. Thus it is not clear if temporary reductions in tinnitus loudness as elicited by short single rTMS sessions can be transferred to daily rTMS treatment. Thus, the aim of the study is to investigate the efficacy and reliability of single sessions of rTMS in chronic tinnitus with respect to temporary reductions in tinnitus loudness accompanied with resting state electroencephalography measurements to investigate the neurophysiological correlates of tinnitus reductions. Two test sessions within one week will be done on the left and right temporoparietal junction using 1Hz, 10Hz, 20Hz and 0.1Hz as active control condition. In the next step patients are divided into three arms with the aim to investigate the efficacy of individualized rTMS. The three arms are 1) patients with temporary tinnitus reductions in test sessions: treatment with the best, most reliable, controlled and most tolerable protocol, 2) patients with temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS, 3) patients with no temporary tinnitus reductions in test sessions: treatment with 1Hz left-sided rTMS. Treatment will be done for 10 days (Monday - Friday) using 2000 pulses with 110% resting motor threshold. Coil position will be tracked with neuronavigation to ensure stable coil Position over the course of the trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: November 30, 2019
• Actual Study Completion Date: November 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: individualized rTMS; Treatment with the best (highest reduction in tinnitus loudness, most reliable, superior to control condition, most tolerable) protocol as obtained in the test sessions (left vs. right temporoparietal junction, 1Hz, 10Hz, 20Hz, 0.1Hz as active control condition).	Device: repetitive transcranial magnetic stimulation; Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation; 2000 pulses; intensity of 110% resting motor threshold; 10 sessions (daily from Monday to Friday); positioning of coil according to EEG position CP5/CP6
Active Comparator: standard rTMS in responders; Treatment with standard protocol: left-sided 1Hz in the group of patients who showed temporary reductions in tinnitus loudness in test sessions.	Device: repetitive transcranial magnetic stimulation; Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation; 2000 pulses; intensity of 110% resting motor threshold; 10 sessions (daily from Monday to Friday); positioning of coil according to EEG position CP5/CP6
Active Comparator: standard rTMS in non-responders; Treatment with standard protocol: left-sided 1Hz in the group of patients who did not show temporary reductions in tinnitus loudness in test sessions.	Device: repetitive transcranial magnetic stimulation; Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation; 2000 pulses; intensity of 110% resting motor threshold; 10 sessions (daily from Monday to Friday); positioning of coil according to EEG position CP5/CP6

Outcome Measures

Primary Outcome Measures :

1. TFI [ Time Frame: 2 weeks ]
   Tinnitus Functional Index

Secondary Outcome Measures :

1. TFI [ Time Frame: 12 weeks ]
   Tinnitus Functional Index
2. Mini-TQ [ Time Frame: 12 weeks ]
   Tinnitus Questionnaire short version
3. THI [ Time Frame: 12 weeks ]
   Tinnitus Handicap inventory
4. Tinnitus Severity [ Time Frame: 12 weeks ]
   Tinnitus numeric Rating scales [0(best) - 10(worst)]
5. MDI [ Time Frame: 12 weeks ]
   Major Depression Inventory
6. WHO-QOL BREF [ Time Frame: 12 weeks ]
   Quality of life [4(worst) - 20(best)]
7. CGI [ Time Frame: 12 weeks ]
   clinical global Impression Change [1(best) - 7(worst)]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria:

• chronic tinnitus (> 6 months)
• at least moderate tinnitus distress
• no or consistent medication
• no or consistent Treatments
• residence in Germany and German speaking

Exclusion Criteria:

• objective tinnitus
• serious and not stable illness (e.g. acute psychosis, severe depression or substance dependence, epilepsy, brain tumor)
• meeting the contraindications for transcranial magnetic stimulation or magnetic resonance imaging (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
• neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
• addictive disorder with consumption in the last two years
• regular intake of benzodiazepines
• participation in another study parallel to the trial
• pregnancy or breastfeeding period
• psychiatric confinement

Contacts and Locations

Locations

Germany

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, Germany, 93053

Sponsors and Collaborators

University of Regensburg

Investigators

• Principal Investigator: Berthold Langguth; University of Regensburg

More Information

• Responsible Party: Berthold Langguth, MD, Ph.D., Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy, University of Regensburg
• ClinicalTrials.gov Identifier: NCT03957122
• Other Study ID Numbers: 17-820-101
• First Posted: May 21, 2019
• Last Update Posted: December 19, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Berthold Langguth, MD, Ph.D., University of Regensburg:

tinnitus; transcranial magnetic stimulation

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases