Clinical trial NCT03957122: Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Official title: Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
transcranial magnetic stimulation
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: TFI
timeFrame: 2 weeks
Secondary outcomes:
measure: TFI
timeFrame: 12 weeks
measure: Mini-TQ
timeFrame: 12 weeks
measure: THI
timeFrame: 12 weeks
measure: Tinnitus Severity
timeFrame: 12 weeks
measure: MDI
timeFrame: 12 weeks
measure: WHO-QOL BREF
timeFrame: 12 weeks
measure: CGI
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References: