Repetitive Transcranial Magnetic Stimulation With Double Cone Coil in Chronic Tinnitus

Chronic Tinnitus Clinical Trial

— Ti-CDC  

Official title:

Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) With Double-Cone-Coil in Patients With Chronic Tinnitus (Ti-CDC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663311
• Other study ID #: Uni-Reg-Ti-CDC01
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: April 25, 2014
• Start date: July 2012
• Est. completion date: September 2013

Study information

• Verified date: April 2014
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

Device:
• 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
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.

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/ day 12)		Day 12	No
Secondary	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	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Baseline vs. day 90	No
Secondary	Change in quality of life as measured by the WHOQoL		Baseline vs. day 90	No