rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Multisite rTMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Regensburg
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01663324
First received: July 23, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.


Condition Intervention
Chronic Tinnitus
Device: rTMS intervention 1
Device: rTMS intervention 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12) [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12) [ Time Frame: Day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Change of depressive symptoms as measured by the Major Depression Inventory (MDI) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change in quality of life as measured by the WHOQoL [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen" [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single site rTMS

Low frequency temporoparietal transcranial magnetic stimulation

Intervention: Device: rTMS intervention 1

Device: rTMS intervention 1

Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.

Arms: single site rTMS

Experimental: multisite rTMS

Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation

Intervention: Device: rTMS Intervention 2

Device: rTMS intervention 2

Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold).

Arms: multisite rTMS


Detailed Description:

Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of subjective chronic tinnitus
  • THI > 38
  • Duration of tinnitus more than 6 months

Exclusion Criteria:

  • Objective tinnitus
  • Treatable cause of the tinnitus
  • Involvement in other treatments for tinnitus at the same time
  • Clinically relevant psychiatric comorbidity
  • Clinically relevant unstable internal or neurological comorbidity
  • History of or evidence of significant brain malformation or neoplasm, head injury
  • Cerebral vascular events
  • Neurodegenerative disorder affecting the brain or prior brain surgery;
  • Metal objects in and around body that can not be removed
  • Pregnancy
  • Alcohol or drug abuse
  • Prior treatment with TMS
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663324

Contacts
Contact: Berthold Langguth, MD, Ph.D. +49 941 941 ext 1256 berthold.langguth@medbo.de

Locations
Germany
University of Regensburg- Dept of Psychiatry Recruiting
Regensburg, Germany, 93053
Contact: Berthold Langguth, MD, Ph.D.    +49 941 941 ext 1256    berthold.langguth@medbo.de   
Principal Investigator: Berthold Langguth, MD, Ph.D.         
Sub-Investigator: Peter Kreuzer, MD, Dr.         
Sub-Investigator: Timm Pöppl, MD, Dr.         
Sub-Investigator: Martin Schecklmann, Ph.D.         
Sub-Investigator: Astrid Lehner, Dipl. Psych.         
Sponsors and Collaborators
University of Regensburg
Investigators
Principal Investigator: Berthold Langguth, MD, Ph.D. University of Regensburg, Dept of Psychiatry
  More Information

No publications provided by University of Regensburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berthold Langguth, MD, Ph.D., MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier: NCT01663324     History of Changes
Other Study ID Numbers: Uni-Reg-multisite-rTMS-Tin-01
Study First Received: July 23, 2012
Last Updated: April 7, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
Tinnitus
chronic subjective Tinnitus
transcranial magnetic stimulation
rTMS
hearing disorders

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014