Verify the Effectiveness rTMS Using MEG

Seoul National University

Status: Unknown

Conditions: Tinnitus

Treatments: Device: 4; Device: 1; Device: 3; Device: 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01874444

TN2447

Details and patient eligibility

About

The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus

Full 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)

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 4 patient groups

Active rTMS1

Experimental group

Description:

Combined low frequency frontal and temporal repetitive transcranial magnetic stimulation of left primary auditory cortex and left dorsolateral prefrontal cortex .

Treatment:

Device: 1

Active rTMS2

Experimental group

Description:

Temporal low frequency rTMS of left primary auditory cortex.

Treatment:

Device: 2

Active rTMS3

Experimental group

Description:

Frontal low frequency rTMS of left dorsolateral prefrontal cortex .

Treatment:

Device: 3

Sham rTMS4

Sham Comparator group

Description:

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

Treatment:

Device: 4