Transcranial Magnetic Stimulation for Tinnitus

Tinnitus Clinical Trial

Official title:

Clinical Trial of Transcranial Magnetic Stimulation for Relief of Tinnitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01104207
• Other study ID #: C7448-I
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 13, 2010
• Last updated: May 25, 2016
• Start date: March 2011
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• placebo rTMS
placebo rTMS

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Functional Index score		1, 2, 4, 13 and 26 weeks post-treatment	No
Secondary	Tinnitus loudness		1, 2, 4, 13 and 26 weeks post-treatment	No