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

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ClinicalTrials.gov Identifier: NCT03957122
Recruitment Status : Terminated (The number of responders in the test sessions was too low.)
First Posted : May 21, 2019
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date December 19, 2019
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
TFI [ Time Frame: 2 weeks ]
Tinnitus Functional Index
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • TFI [ Time Frame: 12 weeks ]
    Tinnitus Functional Index
  • Mini-TQ [ Time Frame: 12 weeks ]
    Tinnitus Questionnaire short version
  • THI [ Time Frame: 12 weeks ]
    Tinnitus Handicap inventory
  • Tinnitus Severity [ Time Frame: 12 weeks ]
    Tinnitus numeric Rating scales [0(best) - 10(worst)]
  • MDI [ Time Frame: 12 weeks ]
    Major Depression Inventory
  • WHO-QOL BREF [ Time Frame: 12 weeks ]
    Quality of life [4(worst) - 20(best)]
  • CGI [ Time Frame: 12 weeks ]
    clinical global Impression Change [1(best) - 7(worst)]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • TFI [ Time Frame: 12 weeks ]
    Tinnitus Functional Index
  • Mini-TQ [ Time Frame: 12 weeks ]
    Tinnitus Questionnaire short version
  • THI [ Time Frame: 12 weeks ]
    Tinnitus Handicap inventory
  • Tinnitus Severity [ Time Frame: 12 weeks ]
    Tinnitus numeric Rating scales
  • MDI [ Time Frame: 12 weeks ]
    Major Depression Inventory
  • WHO-QOL BREF [ Time Frame: 12 weeks ]
    Quality of life
  • CGI [ Time Frame: 12 weeks ]
    clinical global Impression change
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
Official Title  ICMJE Individualized Treatment of Patients With Chronic Tinnitus With Repetitive Transcranial Magnetic Stimulation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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).
    Intervention: Device: repetitive transcranial magnetic stimulation
  • 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.
    Intervention: Device: repetitive transcranial magnetic stimulation
  • 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.
    Intervention: Device: repetitive transcranial magnetic stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 17, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2019)
50
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957122
Other Study ID Numbers  ICMJE 17-820-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Berthold Langguth, MD, Ph.D., University of Regensburg
Study Sponsor  ICMJE University of Regensburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Berthold Langguth University of Regensburg
PRS Account University of Regensburg
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP