Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation

Tinnitus Clinical Trial

— indiTMS  

Official title:

Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03957122
• Other study ID #: 17-820-101
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TFI	Tinnitus Functional Index	2 weeks
Secondary	TFI	Tinnitus Functional Index	12 weeks
Secondary	Mini-TQ	Tinnitus Questionnaire short version	12 weeks
Secondary	THI	Tinnitus Handicap inventory	12 weeks
Secondary	Tinnitus Severity	Tinnitus numeric Rating scales [0(best) - 10(worst)]	12 weeks
Secondary	MDI	Major Depression Inventory	12 weeks
Secondary	WHO-QOL BREF	Quality of life [4(worst) - 20(best)]	12 weeks
Secondary	CGI	clinical global Impression Change [1(best) - 7(worst)]	12 weeks