Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus

Not Applicable

Completed

• Conditions: Chronic Tinnitus
• Interventions: Device: Medial Frontal rTMS Double-Cone-Coil; Device: Left DLPFC Butterfly Coil

• Registration Number: NCT01663311
• Lead Sponsor: University of Regensburg

Brief Summary

Transcranial Magnetic Stimulation is used to modulate both the auditory neural pathways contributing to the perception of phantom sounds, and the regulatory neural network responsible for the generation of the individual amount of suffering caused by chronic tinnitus.

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 generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Low-frequency rTMS applied to the temporoparietal areas has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that taking into account affective components of the multiple overlapping neural networks responsible for the generation of a bothersome subjective tinnitus might enhance the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in chronic tinnitus. A newly developed coil, the so-called double cone coil will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a controlled pilot trial.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of bothersome, subjective chronic tinnitus
• Duration of tinnitus more than 6 months

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medial Frontal rTMS Double-Cone-Coil	Medial Frontal rTMS Double-Cone-Coil	High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 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.
Left DLPFC Butterfly Coil	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller, Tinnitus Handicap Inventory (THI), Tinnitus Severity Scale and TBF-12	Baseline vs. day 90
Change of depressive symptoms as measured by the Major Depression Inventory (MDI)	Baseline vs. day 90
Change in quality of life as measured by the WHOQoL	Baseline vs. day 90

Trial Locations

Locations (1)

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