rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network (Multisite rTMS)
Primary Purpose
Chronic Tinnitus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
rTMS intervention 1
rTMS intervention 2
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Tinnitus focused on measuring Tinnitus, chronic subjective Tinnitus, transcranial magnetic stimulation, rTMS, hearing disorders
Eligibility 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
Sites / Locations
- University of Regensburg- Dept of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
single site rTMS
multisite rTMS
Arm Description
Low frequency temporoparietal transcranial magnetic stimulation Intervention: Device: rTMS intervention 1
Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation Intervention: Device: rTMS Intervention 2
Outcomes
Primary Outcome Measures
Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)
Secondary Outcome Measures
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Change in quality of life as measured by the WHOQoL
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Change in quality of life as measured by the WHOQoL
Change in quality of life as measured by the WHOQoL
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01663324
Brief Title
rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network
Acronym
Multisite rTMS
Official Title
Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory neural pathways contributing to the perception of phantom sounds.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus
Keywords
Tinnitus, chronic subjective Tinnitus, transcranial magnetic stimulation, rTMS, hearing disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single site rTMS
Arm Type
Experimental
Arm Description
Low frequency temporoparietal transcranial magnetic stimulation
Intervention: Device: rTMS intervention 1
Arm Title
multisite rTMS
Arm Type
Experimental
Arm Description
Combined high frequency dorsolateral prefrontal (unilateral) and low frequency temporoparietal (bilateral) stimulation
Intervention: Device: rTMS Intervention 2
Intervention Type
Device
Intervention Name(s)
rTMS intervention 1
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
rTMS intervention 2
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)
Time Frame
Day 12
Title
Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)
Time Frame
Day 12
Secondary Outcome Measure Information:
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Day 12
Title
Change in quality of life as measured by the WHOQoL
Time Frame
Day 12
Title
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame
Day 12
Title
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)
Time Frame
Day 90
Title
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame
Day 12
Title
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame
Day 90
Title
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
Time Frame
Day 180
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Day 180
Title
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
Time Frame
Day 90
Title
Change in quality of life as measured by the WHOQoL
Time Frame
Day 90
Title
Change in quality of life as measured by the WHOQoL
Time Frame
Day 180
Title
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame
Day 90
Title
Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
Time Frame
Day 180
Title
Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)
Time Frame
Day 180
Title
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame
Day 90
Title
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
Time Frame
Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD, Ph.D.
Organizational Affiliation
University of Regensburg, Dept of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg- Dept of Psychiatry
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26927363
Citation
Lehner A, Schecklmann M, Greenlee MW, Rupprecht R, Langguth B. Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial. Sci Rep. 2016 Mar 1;6:22302. doi: 10.1038/srep22302.
Results Reference
result
PubMed Identifier
23968498
Citation
Lehner A, Schecklmann M, Kreuzer PM, Poeppl TB, Rupprecht R, Langguth B. Comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial. Trials. 2013 Aug 23;14:269. doi: 10.1186/1745-6215-14-269. Erratum In: Trials. 2014;5:148.
Results Reference
derived
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rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network
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