Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

NCT01886092 | Unknown DMC

• 2 other identifiers: H-1212-081-451SNUHT1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy of different protocols of transcranial magnetic stimulation for the treatment of tinnitus

Conditions

Tinnitus

Keywords

tinnitus

Outcome Measures

Primary Outcomes (1)

• Change of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)

  Change from Baseline inTinnitus Handicap Inventory at 3 months

Secondary Outcomes (4)

• Beck's Depression Inventory (BDI)

  Baseline, before and after each intervention, 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

• visual analogue scale (VAS)

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

Study Arms (4)

Active rTMS1

ACTIVE COMPARATOR

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

Device: Active rTMS 1

Active rTMS2

ACTIVE COMPARATOR

Temporal low frequency repetitive transcranial magnetic stimulation of left primary auditory cortex

Device: Active rTMS 2

Active rTMS3

ACTIVE COMPARATOR

Frontal low frequency repetitive transcranial magnetic stimulation of left dorsolateral prefrontal cortex

Device: Active rTMS 3

Sham Condition

SHAM COMPARATOR

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

Device: sham condition

Interventions

Active rTMS 1 DEVICE

repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).

Active rTMS1

Active rTMS 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. (20 subjects)

Active rTMS2

Active rTMS 3 DEVICE

repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)

Active rTMS3

sham condition DEVICE

Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)

Sham Condition

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

Related Publications (2)

• Noh TS, Kyong JS, Park MK, Lee JH, Oh SH, Suh MW. Dual-site rTMS is More Effective than Single-site rTMS in Tinnitus Patients: A Blinded Randomized Controlled Trial. Brain Topogr. 2020 Nov;33(6):767-775. doi: 10.1007/s10548-020-00797-y. Epub 2020 Sep 17.

  PMID: 32944806 DERIVED

• 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 25, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2020
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

KR (1)