Combined rTMS and Relaxation in Chronic Tinnitus

Chronic Tinnitus Clinical Trial

— RELAX  

Official title:

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) in Combination With Relaxation Therapy in Patients With Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907022
• Other study ID #: Uni-Reg-Ti-CDC01-RELAX
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: March 11, 2015
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

Device:
• Left DLPFC Butterfly Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions. Arms: Left DLPFC Butterfly Coil

Locations

Country	Name	City	State
Germany	University of Regensburg - Dept of Psychiatry	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment responders (TQ reduction > 5, contrast Baseline versus end of treatment)		Week 12	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller		Week 4	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)		Week 4	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Severity Scale		Week 4	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller		Week 2	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)		Week 2	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Severity Scale		Week 2	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Week 4	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Week 2	No
Secondary	Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)		Week 2	No
Secondary	Change in quality of life as measured by the World Health Organization Quality of Life(WHOQoL)		Week 4	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller		Week 12	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)		Week 12	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Severity Scale		Week 12	No
Secondary	Change in quality of life as measured by the World Health Organization Quality of Life (WHOQoL)		Week 12	No