Verify the Effectiveness rTMS Using MEG

Tinnitus Clinical Trial

— rTMS  

Official title:

Verify the Effectiveness rTMS Using MEG

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01874444
• Other study ID #: TN2447
• Status: Unknown status
• Phase: N/A
• First received: June 4, 2013
• Last updated: November 18, 2014
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

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
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MEG Asymmetry Index and amplitude of the auditory area		Baseline, After active treatment week
Secondary	Tinnitus Handicap Inventory (THI)		Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Secondary	Visual Analog Scales (VAS)		Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention
Secondary	State-Trait Anxiety Inventory (STAI)		Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Secondary	Pittsburgh Sleep Quality Index (PSQI)		Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention
Secondary	Beck Depression Inventory (BDI)		Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention