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

NCT ID: NCT03957122

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Tinnitus

Keywords

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tinnitus transcranial magnetic stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Berthold Langguth, MD, Ph.D.

Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berthold Langguth

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

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Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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17-820-101

Identifier Type: -

Identifier Source: org_study_id