Clinical trial NCT01907022: Combined rTMS and Relaxation in Chronic Tinnitus
Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Tinnitus
Keywords: repetitive transcranial magnetic stimulation
chronic tinnitus
relaxation
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress 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. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. Treatment remains difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS applied to the left frontal cortex. Newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bothersome, subjective chronic tinnitus
* 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 end of treatment)
timeFrame: Week 12
Secondary outcomes:
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
timeFrame: Week 4
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
timeFrame: Week 4
measure: Change of tinnitus severity as measured by the Tinnitus Severity Scale
timeFrame: Week 4
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
timeFrame: Week 2
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
timeFrame: Week 2
measure: Change of tinnitus severity as measured by the Tinnitus Severity Scale
timeFrame: Week 2
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Week 4
measure: Change of depressive symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Week 2
measure: Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
timeFrame: Week 2
measure: Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)
timeFrame: Week 4
measure: Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller
timeFrame: Week 12
measure: Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)
timeFrame: Week 12
measure: Change of tinnitus severity as measured by the Tinnitus Severity Scale
timeFrame: Week 12
measure: Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)
timeFrame: Week 12
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: