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Transcranial Magnetic Stimulation for Tinnitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01104207
First received: April 13, 2010
Last updated: September 3, 2014
Last verified: September 2014

April 13, 2010
September 3, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
Tinnitus Functional Index score [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ] [ Designated as safety issue: No ]
Tinnitus Handicap Inventory score [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01104207 on ClinicalTrials.gov Archive Site
Tinnitus loudness [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Transcranial Magnetic Stimulation for Tinnitus
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Tinnitus
  • 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.
  • Device: placebo rTMS
    placebo rTMS
  • Experimental: Arm 1
    For half of the subjects, rTMS will be delivered to one side of the head.
    Intervention: Device: repetitive transcranial magnetic stimulation (rTMS)
  • Sham Comparator: Arm 2
    For half of the subjects, placebo rTMS will be delivered to one side of the head.
    Intervention: Device: placebo rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
168
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01104207
C7448-I
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Robert Folmer, PhD VA Medical Center, Portland
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP