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Tinnitus rTMS 2013

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
E-fied navigated rTMS
non-navigated rTMS
sham E-field navigated rTMS
Navigated rTMS
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Transcranial magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Turku University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Experimental

Arm Label

E-fied navigated rTMS

sham E-field navigated rTMS

non-navigated rTMS

Experimental, Navigated rTMS

Arm Description

Electrical field navigated transcranial magnetic stimulation

Sham electrical field navigated rTMS

non-navigated rTMS

Navigated rTMS,

Outcomes

Primary Outcome Measures

The change of loudness and pitch of the tinnitus is psychophysically measured, VAS questionnaires, Tinnitus Handicap Inventory, Tinnitus diary

Secondary Outcome Measures

Full Information

First Posted
June 24, 2013
Last Updated
August 30, 2016
Sponsor
Turku University Hospital
Collaborators
Satakunta Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01929837
Brief Title
Tinnitus rTMS 2013
Official Title
Treatment of Tinnitus With Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
Satakunta Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-fied navigated rTMS
Arm Type
Experimental
Arm Description
Electrical field navigated transcranial magnetic stimulation
Arm Title
sham E-field navigated rTMS
Arm Type
Sham Comparator
Arm Description
Sham electrical field navigated rTMS
Arm Title
non-navigated rTMS
Arm Type
Experimental
Arm Description
non-navigated rTMS
Arm Title
Experimental, Navigated rTMS
Arm Type
Experimental
Arm Description
Navigated rTMS,
Intervention Type
Device
Intervention Name(s)
E-fied navigated rTMS
Intervention Description
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
Intervention Name(s)
non-navigated rTMS
Intervention Description
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
Intervention Name(s)
sham E-field navigated rTMS
Intervention Type
Device
Intervention Name(s)
Navigated rTMS
Intervention Description
1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29188734
Citation
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.
Results Reference
derived

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Tinnitus rTMS 2013

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