Effectiveness Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Tinnitus Clinical Trial

Official title:

Effectiveness of Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876720
• Other study ID #: Uni-Reg-rTMS-Tinnitus-01
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: November 12, 2010
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.

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 is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by high frequency rTMS of the left dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether high frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of subjective chronic tinnitus

• Duration of tinnitus more than 3 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, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• rTMS - Intervention 1
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 20Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
• rTMS - Intervention 2
Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tinnitus severity as measured by the Tinnitus Questionnaire of Goebel and Hiller		Baseline, Day 12	No

External Links

•   Tinnitus Research and Treatment Center at the University of Regensburg