Tinnitus rTMS 2013

Tinnitus Clinical Trial

Official title:

Treatment of Tinnitus With Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929837
• Other study ID #: T69/2013
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: August 30, 2016
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus affects approximately 10-15 % of the population. The prevalence increases with age and it is estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety, depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most therapies focus on alleviating the condition rather than treating the cause. Pathophysiology of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus patients and animal models suggest that tinnitus is associated with increased neuronal activity, increased synchronicity, and functional reorganization within the auditory cortex either uni- or bilaterally, but there are also functional alterations in brain areas outside the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique based on the principle of electromagnetic induction of an electric field in the brain by means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been shown to decrease cortical excitability both in experimental settings and humans, which forms the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom hyperactivity of the auditory cortex has been observed in functional brain imaging studies

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• chronic tinnitus 6 months-10 years

• age 18-65 years

• tinnitus intensity VAS at least 4/10

Exclusion Criteria:

• pulsatile tinnitus

• objective tinnitus

• epilepsy, brain disease

• severe/recent heart disease

• pregnancy

• alcohol abuse

• metallic implants etc.

Study Design

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• E-fied navigated rTMS
1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus
• non-navigated rTMS
1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations)
• sham E-field navigated rTMS

• Navigated rTMS
1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku	Varsinais-Suomi

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Satakunta Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary		Change from baseline and 2-3 days after treatment period	No