Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus

Tinnitus Clinical Trial

— rTMS  

Official title:

Verification of the Usefulness of the Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Tinnitus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01886092
• Other study ID #: H-1212-081-451
• Secondary ID: SNUHT1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2013
• Est. completion date: October 2020

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. The investigators aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 2020
• Est. primary completion date: September 2019
• 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

• 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

• 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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Active rTMS 1
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 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. (20 subjects)
• Active rTMS 3
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)
• sham condition
Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)

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 of tinnitus severity as measured by the Tinnitus Handicap Inventory (THI)		Change from Baseline inTinnitus Handicap Inventory at 3 months
Secondary	Beck's Depression Inventory (BDI)		Baseline, before and after each intervention, 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	visual analogue scale (VAS)		Baseline, day 7, day 14, 1, 2 and 3 months after the first intervention