rTMS Bimodal Treatment For Tinnitus: A Pilot Study

Completed · Not applicable

Conditions studied: Tinnitus

In brief

Repetitive Transcranial Magnetic Stimulation (rTMS) is a novel brain stimulation technique that uses pulsating magnetic fields to stimulate underlying neurons in the cerebral cortex. The investigators propose an open-label pilot study investigating the effectiveness of rTMS in the treatment of tinnitus stimulation of the left dorsolateral prefrontal cortex (DLPFC), an area known to be important for mood and attention, along with stimulation of the left temporoparietal cortex (TPC). This is a feasibility pilot study.

Key facts

Study ID

NCT01590264

Run by

Washington University School of Medicine

People needed

5

Starts

2012-05-01

Expected to finish

2012-09-01

Last updated by the study team

2013-04-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be between the ages of 18 and 60 years.
• Subjective, idiopathic, troublesome, unilateral or bilateral, non-pulsatile tinnitus of ≥ 2 month's duration but no greater than 5 year's duration.
• Bothersome Tinnitus according to Tinnitus Handicap Inventory score.
• Must be able to understand, speak, read and write English proficiently
• Able to provide informed consent
• Women who are of childbearing potential must agree to use a medically acceptable form of birth control and must have a negative urine pregnancy test at screening

You may not qualify if…

• •• Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone. Patients with a history of stapedectomy and insertion of implant will be excluded.
• Hypersensitive to noises (hyperacusis)
• Patients with history of head injury with 15 minutes or more loss of consciousness or required medical treatment.
• Patients with cardiac pacemakers; intracardiac lines; implanted medication pumps; implanted electrodes in the brain; other implanted electrical or magnetic medical devices; or other intracranial metal objects or shrapnel, with the exception of dental fillings.
• Patients with additional significant neurological disorders including increased intracranial pressure, brain mass, epileptic seizures (or family history of epileptic seizures), history of stroke, transient ischemic attack within 2 years, cerebral aneurysm, Huntington's chorea or multiple sclerosis.
• Patients with an acute or unstable medical condition including all patients with any significant heart disease, pneumonia, uncontrolled hypertension, or other disorders which would require stabilization prior to initiation of transcranial magnetic stimulation.
• Active alcohol and/or drug dependence or history of alcohol and/or drug dependence within the last year.
• Patients with moderate to severe clinical depression as evidenced by a score of 15 or greater on the PHQ-9.
• Patients who, in the opinion of the psychiatric sub-investigator, demonstrate moderate to severe depressive symptoms according to DSM-IV-TR criteria for Major Depressive Disorder.
• Patients with psychiatric illness or trauma which would prohibit participation in the study.
• Patients with active psychotic symptoms or a history of psychotic disorder
• Female patients of child-bearing potential, unless sterilized or using an appropriate form of birth control acceptable to the research team.
• Currently breastfeeding
• Currently pregnant
• Patients will be excluded if a motor threshold cannot be elicited,
• Patients whose ability to give informed consent is in question
• Undiagnosed symptomatic hypertension: .
• Undiagnosed asymptomatic hypertension:
• Any patient who has scheduled an elective surgery or change in medication during the 5 weeks of the study.
• Use of Neuromonics Device during duration of study or currently in Tinnitus Retraining Program during course of study.
• Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk.
• Patients currently taking psychotropic medications including antidepressants, benzodiazepines, anticonvulsants, stimulants, antipsychotics, or anxiolytics.
• Tinnitus related to a Workman's Compensation claim or litigation-related event that is still pending.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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