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Trial record 3 of 141 for:    "Tinnitus"

Tinnitus rTMS 2013

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Turku University Hospital
Sponsor:
Collaborator:
Satakunta Central Hospital
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01929837
First received: June 24, 2013
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention
Tinnitus
Device: E-fied navigated rTMS
Device: non-navigated rTMS
Device: sham E-field navigated rTMS
Device: Navigated rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Tinnitus With Transcranial Magnetic Stimulation

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary [ Time Frame: Change from baseline and 2-3 days after treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E-fied navigated rTMS
Electrical field navigated transcranial magnetic stimulation
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
Sham Comparator: sham E-field navigated rTMS
Sham electrical field navigated rTMS
Device: sham E-field navigated rTMS
Experimental: non-navigated rTMS
non-navigated rTMS
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)
Experimental: Experimental, Navigated rTMS
Navigated rTMS,
Device: Navigated rTMS
1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929837

Contacts
Contact: Hanna Sahlsten hanna.sahlsten@hotmail.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Varsinais-Suomi, Finland, 20521
Contact: Hanna Sahlsten       hanna.sahlsten@hotmail.fi   
Sponsors and Collaborators
Turku University Hospital
Satakunta Central Hospital
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01929837     History of Changes
Other Study ID Numbers: T69/2013
Study First Received: June 24, 2013
Last Updated: November 17, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
Tinnitus
Transcranial magnetic stimulation

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014