rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network

Chronic Tinnitus Clinical Trial

— Multisite rTMS  

Official title:

Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus: Optimization by Stimulation of the Cortical Tinnitus Network

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663324
• Other study ID #: Uni-Reg-multisite-rTMS-Tin-01
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: May 17, 2016
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: May 2016
• 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 and non-auditory neural pathways contributing to the perception 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. Treatment remains difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus has been shown to be associated with functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) applied to the temporoparietal areas has been investigated for the treatment of tinnitus. Additionally, there is growing evidence that a neural network of both auditory and non-auditory cortical areas is involved in the pathophysiology of chronic subjective tinnitus. Targeting several core regions of this network by rTMS might constitute a promising strategy to enhance treatment effects. A new multisite treatment protocol which is supposed to have an effect on both auditory and non-auditory cortical areas 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: 50
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of subjective chronic tinnitus

• THI > 38

• 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:
• rTMS intervention 1
Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli. Arms: single site rTMS
• rTMS intervention 2
Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Arms: multisite rTMS

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, 

References & Publications (1)

Lehner A, Schecklmann M, Greenlee MW, Rupprecht R, Langguth B. Triple-site rTMS for the treatment of chronic tinnitus: a randomized controlled trial. Sci Rep. 2016 Mar 1;6:22302. doi: 10.1038/srep22302. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment responders (TQ reduction =5, contrast baseline versus day 12)		Day 12	No
Primary	Change of tinnitus severity as measured by the Tinnitus Questionnaire of Goebel&Hiller (contrast baseline versus day 12)		Day 12	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Day 12	No
Secondary	Change in quality of life as measured by the WHOQoL		Day 12	No
Secondary	Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"		Day 12	No
Secondary	Number of treatment responders (TQ reduction =5, contrast Baseline versus day 90)		Day 90	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale		Day 12	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale		Day 90	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) and Tinnitus Severity Scale		Day 180	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Day 180	No
Secondary	Change of depressive symptoms as measured by the Major Depression Inventory (MDI)		Day 90	No
Secondary	Change in quality of life as measured by the WHOQoL		Day 90	No
Secondary	Change in quality of life as measured by the WHOQoL		Day 180	No
Secondary	Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"		Day 90	No
Secondary	Change in hyperacusis as measured by the German questionnaire "Geräuschüberempfindlichkeitsfragebogen"		Day 180	No
Secondary	Number of treatment responders (TQ reduction =5, contrast Baseline versus day 180)		Day 180	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller		Day 90	No
Secondary	Change of tinnitus severity as measured by the Tinnitus Questionaire of Goebel&Hiller		Day 180	No