Transcranial Magnetic Stimulation for Tinnitus

February 27, 2017 updated by: VA Office of Research and Development

Clinical Trial of Transcranial Magnetic Stimulation for Relief of Tinnitus

The purpose of this study is to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for reducing the loudness or severity of chronic tinnitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, subject and clinician/observer blind, placebo-controlled parallel-group clinical trial of rTMS involving people who experience chronic tinnitus. Eligible subjects are randomly assigned to receive either active rTMS treatment or placebo treatment to either the left or right side of the head. Subjects receive 2000 pulses of 1 Hz rTMS therapy daily on 10 consecutive work days. Outcomes are measured prior to the start of treatment and after the last therapeutic session. Follow-up evaluations are conducted 1, 2, 4, 13 and 26 weeks after the last treatment session. This design allows us to determine if rTMS reduces the severity and loudness of tinnitus, the long-term duration of relief, and whether the target for coil placement (left/right side of head) affects active rTMS efficacy.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 1

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
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, Portland, OR

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic tinnitus.
  • Able to provide written informed consent.
  • Subject is naive regarding rTMS.
  • Age/Gender: minimum 18 years old, with an attempt to sample equal numbers of male and female subjects.
  • Other concurrent treatments: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.
  • Other medications: No restrictions, provided the dosages have been in place for at least 6 months.
  • Psychological status: Stable enough to complete this study per the opinion of the Study Physician.
  • Hearing function: All degrees of hearing function can be included recognizing that profound, bilateral losses will not be able to perform tinnitus evaluations and hearing tests, but will be able to rate subjective tinnitus loudness, annoyance and impact on life. This is an important subpopulation because of the challenges in treating them with acoustic therapy and the need for a medical intervention.

  • Tinnitus characteristics: All forms of tinnitus etiology will be accepted, providing the following criteria are met:

    • Tinnitus duration: Not less than 1 year. Cases of less than 1 year duration have increased likelihood of resolving spontaneously.
    • Stability: Constant (not pulsatile, intermittent, varying to a high degree in loudness or changing in location of perception). Fluctuating tinnitus reduces the reliability of test-retest measures for loudness.
    • Self-rated tinnitus loudness: >= 6 on a visual numerical scale (VNS: 0 labeled "No Tinnitus", 10 labeled "Very Loud"). This outcome measure will provide a subjective indication of immediate changes in perceived loudness.
    • Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral, bilateral, or perceived in the head.

Exclusion Criteria:

  • Medical conditions: No active neurologic or otologic disease processes that may impact tinnitus perception. No auto-immune diseases. No pregnancy or planned pregnancy during the study. No women who are lactating or are of child-bearing-age without using contraception.
  • Objective Tinnitus - tinnitus that is audible to other people in addition to the patient. This type of tinnitus is rare and is unlikely to respond to rTMS because it is not associated with abnormal neural activity in the central auditory system.
  • History or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events (such as strokes), neurodegenerative disorders affecting the brain (such as Parkinson's Disease, ALS, Huntington's Disease or Multiple Sclerosis) or prior brain surgery.
  • Cardiac pace makers, other electronic implants (including cochlear implants), intracranial or intraocular metallic particles.
  • History of seizures or epileptic activity.
  • Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the trial.
  • Participation in a clinical trial within the last 30 days before the start of this one.
  • Maximum number of previous clinical trials for tinnitus in which subjects may have participated: two.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Half of the study participants will receive 2000 pulses of 1 Hz active rTMS daily on 10 consecutive work days.
Device: repetitive transcranial magnetic stimulation (rTMS)
rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.
Sham Comparator: Arm 2
Half of the study participants will receive 2000 pulses of 1 Hz placebo rTMS daily on 10 consecutive work days.
Device: placebo rTMS
placebo rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tinnitus Functional Index (TFI) Score
Time Frame: 26 weeks post-treatment
The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.
26 weeks post-treatment

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Robert Folmer, PhD, VA Portland Health Care System, Portland, OR

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

March 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C7448-I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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