rTMS Bimodal Treatment For Tinnitus: A Pilot Study

February 25, 2013 updated by: Jay F. Piccirillo, MD, Washington University School of Medicine

rTMS Bimodal Treatment For Patients With Subjective Idiopathic Tinnitus: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Converging data implicate structures of the brain that are important for mood and attention as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment approach that targets these structures. A growing number of studies demonstrate involvement of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal cortex has been shown to increase the durability of the TPC stimulation. The independent effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that increasing the intensity and duration of stimulation has beneficial treatment effects. However, the field is new and more work is needed to assess the effectiveness of this treatment, predictors and correlates of response, and safety.

Recent exciting work in schizophrenia used a bimodal (DLPFC and TPC) treatment approach in pharmacologically non-responsive patients. The study used high-frequency stimulation to the left DLPFC and low-frequency stimulation to the left TPC. Bimodal rTMS stimulation of left DLPFC and left TPC induced clinical improvement in pharmacologically non-responsive schizophrenia patients and may have improved their short-term verbal memories.57

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • •• 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Bimodal rTMS

Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)

Stimulation Settings:

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000
Device: Bimodal rTMS

High frequency (10 Hz) at 110% of the motor threshold TMS delivered over the left dorsolateral prefrontal cortex, subsequently, a low frequency TMS (1 Hz) at 110% motor threshold will be delivered over 31 minutes over the TPJ area, according to the protocol below.

DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000

TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000

Other Names:
  • The rTMS system is a Magpro R 30 stimulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Daily for 2 weeks.
Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.
Daily for 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tinnitus Handicap Inventory
Time Frame: Baseline, 2 weeks
Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.
Baseline, 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jay F Piccirillo, MD, Washington University School of Medicine, St. Louis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (ESTIMATE)

May 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201204069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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