Verify the Effectiveness rTMS Using MEG

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01874444
First received: June 4, 2013
Last updated: December 3, 2013
Last verified: December 2013
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Visual Analog Scales (VAS) [ Time Frame: Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2014 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: NCT01874444

Contacts
Contact: Tae-Soo Noh, BS 82-02-2072-2447 drmung@naver.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Oh    82-02-2072-2114    snuhirb@gmail.net   
Sub-Investigator: Jun Ho Lee, MD, ph.D         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Myung-Whan Suh, MD, ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01874444     History of Changes
Other Study ID Numbers: TN2447
Study First Received: June 4, 2013
Last Updated: December 3, 2013
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014