Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03957122
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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




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)]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957122


Contacts
Layout table for location contacts
Contact: Martin Schecklmann, PhD +49-941-941-2054 martin.schecklmann@medbo.de
Contact: Berthold Langguth, PhD, MD

Locations
Layout table for location information
Germany
Department of Psychiatry and Psychotherapy, University of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Berthold Langguth    +49-941-941-2099    berthold.langguth@medbo.de   
Sponsors and Collaborators
University of Regensburg
Investigators
Layout table for investigator information
Principal Investigator: Berthold Langguth University of Regensburg

Layout table for additonal 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     History of Changes
Other Study ID Numbers: 17-820-101
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms