Clinical trial NCT01663324: rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network
Official title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Keywords: Tinnitus
chronic subjective Tinnitus
transcranial magnetic stimulation
rTMS
hearing disorders
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of treatment responders (TQ reduction ≥5, contrast baseline versus day 12)
timeFrame: Day 12
measure: Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)
timeFrame: Day 12
Secondary outcomes:
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Day 12
measure: Change in quality of life as measured by the WHOQoL
timeFrame: Day 12
measure: Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
timeFrame: Day 12
measure: Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 90)
timeFrame: Day 90
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
timeFrame: Day 12
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
timeFrame: Day 90
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale
timeFrame: Day 180
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Day 180
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Day 90
measure: Change in quality of life as measured by the WHOQoL
timeFrame: Day 90
measure: Change in quality of life as measured by the WHOQoL
timeFrame: Day 180
measure: Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
timeFrame: Day 90
measure: Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"
timeFrame: Day 180
measure: Number of treatment responders (TQ reduction ≥5, contrast Baseline versus day 180)
timeFrame: Day 180
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
timeFrame: Day 90
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
timeFrame: Day 180
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University of Regensburg- Dept of Psychiatry
Study officials:
affiliation: University of Regensburg, Dept of Psychiatry
name: Berthold Langguth, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.