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Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus (rTMS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Seoul National University Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01886092
First Posted: June 25, 2013
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seoul National University Hospital
  Purpose
Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus

Condition Intervention
Tinnitus Device: Active rTMS 1 Device: Active rTMS 2 Device: Active rTMS 3 Device: sham condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI) [ Time Frame: Change from Baseline inTinnitus Handicap Inventory at 3 months ]

Secondary Outcome Measures:
  • Beck's Depression Inventory (BDI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ]
  • State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ]
  • visual analogue scale (VAS) [ Time Frame: Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention ]

Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Device: Active rTMS 1
repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
Active Comparator: Active rTMS2
Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex
Device: Active rTMS 2
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects)
Active Comparator: Active rTMS3
Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex
Device: Active rTMS 3
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
Sham Comparator: Sham Condition
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex
Device: sham condition
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)

Detailed Description:
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic tinnitus
  • Chronic subjective tinnitus for more than 6 months
  • Subject is naive regarding rTMS
  • Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study
  • Stable enough to complete this study per the opinion of the Study Physician
  • No restrictions, provided the dosages have been in place for at least 3 months
  • A three month washout from any other tinnitus treatment or management program is required prior to entering this study.

Exclusion Criteria:

  • Objective tinnitus or tinnitus with treatable cause
  • Presence of intracranial or intraocular ferromagnetic materiel or particles
  • Cardiac pacemaker or other electronic implants (including cochlear implant) Serious heart disease or other unstable major medical condition
  • Personal history of central nervous system disorder, head injury, stroke or seizures
  • Familial history of epilepsy
  • Concomitant medication with antidepressants and antipsychotics
  • Pregnant women
  • Others known contraindications to rTMS or brain MRI
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886092


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Myung-Whan Suh, MD, ph.D Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01886092     History of Changes
Other Study ID Numbers: H-1212-081-451
SNUHT1 ( Other Identifier: SNUHT1 )
First Submitted: June 4, 2013
First Posted: June 25, 2013
Last Update Posted: October 30, 2015
Last Verified: September 2015

Keywords provided by Seoul National University Hospital:
tinnitus

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