Tinnitus rTMS 2013

NCT ID: NCT01929837

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-08-31

Brief 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

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

E-fied navigated rTMS

Electrical field navigated transcranial magnetic stimulation

Group Type: EXPERIMENTAL

E-fied navigated rTMS

Intervention Type: DEVICE

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

sham E-field navigated rTMS

Sham electrical field navigated rTMS

Group Type: SHAM_COMPARATOR

sham E-field navigated rTMS

Intervention Type: DEVICE

non-navigated rTMS

non-navigated rTMS

Group Type: EXPERIMENTAL

non-navigated rTMS

Intervention Type: DEVICE

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)

Experimental, Navigated rTMS

Navigated rTMS,

Group Type: EXPERIMENTAL

Navigated rTMS

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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)

Intervention Type: DEVICE

sham E-field navigated rTMS

Intervention Type: DEVICE

Navigated rTMS

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satakunta Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Turku University Hospital

Turku, Southwest Finland, Finland

Countries

Finland

References

Sahlsten H, Taiminen T, Karukivi M, Sjosten N, Nikkila J, Virtanen J, Paavola J, Joutsa J, Niinivirta-Joutsa K, Takala M, Holm A, Rauhala E, Loyttyniemi E, Johansson R, Jaaskelainen SK. Psychiatric (Axis I) and personality (Axis II) disorders and subjective psychiatric symptoms in chronic tinnitus. Int J Audiol. 2018 Apr;57(4):302-312. doi: 10.1080/14992027.2017.1409440. Epub 2017 Nov 30.

Reference Type: DERIVED

PMID: 29188734 (View on PubMed)

Other Identifiers

T69/2013

Identifier Type: -

Identifier Source: org_study_id