Verify the Effectiveness rTMS Using MEG

NCT01874444 | Unknown DMC

• 1 other identifier: TN2447
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Change in MEG Asymmetry Index and amplitude of the auditory area

  Baseline, After active treatment week

Secondary Outcomes (5)

• Tinnitus Handicap Inventory (THI)

  Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention

• Visual Analog Scales (VAS)

  Baseline, day 3, day 7, day 14, 1, 2 and 3 months after the first intervention

• State-Trait Anxiety Inventory (STAI)

  Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

• Beck Depression Inventory (BDI)

  Baseline, before and after each intervention, 1, 2 and 3 months after the first intervention

Study Arms (4)

Active rTMS1

EXPERIMENTAL

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

Device: 1

Active rTMS2

EXPERIMENTAL

Temporal low frequency rTMS of left primary auditory cortex.

Device: 2

Active rTMS3

EXPERIMENTAL

Frontal low frequency rTMS of left dorsolateral prefrontal cortex .

Device: 3

Sham rTMS4

SHAM COMPARATOR

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

Device: 4

Interventions

1 DEVICE

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

Active rTMS1

2 DEVICE

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.

Active rTMS2

3 DEVICE

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.

Active rTMS3

4 DEVICE

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.

Sham rTMS4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Chung CK, Kim JS, Suh MW. Treatment Outcome of Auditory and Frontal Dual-Site rTMS in Tinnitus Patients and Changes in Magnetoencephalographic Functional Connectivity after rTMS: Double-Blind Randomized Controlled Trial. Audiol Neurootol. 2019;24(6):293-298. doi: 10.1159/000503134. Epub 2019 Dec 12.

  PMID: 31830753 DERIVED

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Myung-Whan Suh, MD, ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 19, 2014

Record last verified: 2013-12

Locations

KR (1)