Combined rTMS and Relaxation in Chronic Tinnitus

Not Applicable

Completed

• Conditions: Chronic Tinnitus

• Registration Number: NCT01907022
• Lead Sponsor: University of Regensburg

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)	Week 12

Secondary Outcome Measures

Name	Time	Method
Change of tinnitus severity as measured by the Tinnitus Severity Scale	Week 12
Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)	Week 12
Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)	Week 12
Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)	Week 4
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller	Week 12
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)	Week 2

Trial Locations

Locations (1)

University of Regensburg - Dept of Psychiatry; 🇩🇪 Regensburg, Germany