Repetitive Transcranial Magnetic Stimulation as a Treatment for Tinnitus (rTMS)

Seoul National University

Status: Unknown

Conditions: Tinnitus

Treatments: Device: Active rTMS 2; Device: sham condition; Device: Active rTMS 3; Device: Active rTMS 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01886092

H-1212-081-451

SNUHT1 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 4 patient groups

Active rTMS1

Active Comparator group

Description:

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

Treatment:

Device: Active rTMS 1

Active rTMS2

Active Comparator group

Description:

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

Treatment:

Device: Active rTMS 2

Active rTMS3

Active Comparator group

Description:

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

Treatment:

Device: Active rTMS 3

Sham Condition

Sham Comparator group

Description:

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

Treatment:

Device: sham condition