Objective Diagnosis Method and Efficacy of Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

NCT02617953 | Unknown DMC

• 1 other identifier: A-199-08-14
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of objective tinnitus diagnosis method through measurement of continuous resting EEG, auditory ERP before and after Repetitive Transcranial Magnetic Stimulation (rTMS) treatment of tinnitus.

Conditions

Tinnitus

Keywords

Tinnitus; EEG; ERP

Outcome Measures

Primary Outcomes (1)

• Change of Tinnitus Handicap Inventory (THI) before and after treatment , difference in brain gating and connectivity before and after treatment.

  Change from Baseline THI at 6 months

Secondary Outcomes (5)

• Change of Visual Analogue Scale (VAS) for tinnitus states before and after treatment.

  Change from Baseline VAS at 6 months

• Positive And Negative Affect Schedule(PANAS)

  Baseline, 1, 2 and 3 month after the first intervention

• Beck's Depression Inventory (BDI)

  Baseline

• State-Trait Anxiety Inventory (STAI)

  Baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline

Study Arms (3)

Active rTMS(A)

EXPERIMENTAL

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Device: Active rTMS(A)

Active rTMS(B)

EXPERIMENTAL

Temporal low frequency repetitive transcranial magnetic stimulation

Device: Active rTMS(B)

Sham condition(C)

SHAM COMPARATOR

low frequency frontal and temporal repetitive transcranial magnetic stimulation

Device: Sham condition(C)

Interventions

Active rTMS(A) DEVICE

repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.

Active rTMS(A)

Active rTMS(B) DEVICE

repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.

Active rTMS(B)

Sham condition(C) DEVICE

The sham stimulation looks and sounds like the active coil, but diverts the magnetic field away from the patient. auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train.

Sham condition(C)

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
• 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
• 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
• Others known contraindications to rTMS or brain MRI

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

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: October 28, 2015
• First Posted: December 1, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)