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Verify the Effectiveness rTMS Using MEG (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 December 2013 by Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874444
First Posted: June 11, 2013
Last Update Posted: October 12, 2017
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
The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus

Condition Intervention
Tinnitus Device: 1 Device: 2 Device: 3 Device: 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Verify the Effectiveness rTMS Using MEG

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change in MEG Asymmetry Index and amplitude of the auditory area [ Time Frame: Baseline, After active treatment week ]

Secondary Outcome Measures:
  • Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention ]
  • Visual Analog Scales (VAS) [ Time Frame: Baseline, day 3, day 7, day 14, 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 ]
  • Beck Depression Inventory (BDI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ]

Estimated Enrollment: 28
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active rTMS1
Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .
Device: 1
repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS
Experimental: Active rTMS2
Temporal low frequency rTMS of left primary auditory cortex.
Device: 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.

Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.

Experimental: Active rTMS3
Frontal low frequency rTMS of left dorsolateral prefrontal cortex .
Device: 3

repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment.

Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.

Sham Comparator: Sham rTMS4
sham treatment Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
Device: 4

Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.

Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS.


Detailed Description:
Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)
  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
  • Pure tone average <50 dB HL in the ear where tinnitus is perceived
  • Dominant tinnitus frequency measured between 4 and 8 kHz
  • 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
  • Absolute thresholds > 60 dB on individual frequencies up to 8 kHz
  • 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
  • Severe depression
  • Severe anxiety
  • 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): NCT01874444


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
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: NCT01874444     History of Changes
Other Study ID Numbers: TN2447
First Submitted: June 4, 2013
First Posted: June 11, 2013
Last Update Posted: October 12, 2017
Last Verified: December 2013

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