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Transcranial Magnetic Stimulation for Tinnitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104207
First Posted: April 15, 2010
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
April 13, 2010
April 15, 2010
January 4, 2017
February 23, 2017
March 29, 2017
March 2011
December 2016   (Final data collection date for primary outcome measure)
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.
Tinnitus Handicap Inventory score [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ]
Complete list of historical versions of study NCT01104207 on ClinicalTrials.gov Archive Site
Not Provided
Tinnitus loudness [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ]
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
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
    Half of the study participants will receive 2000 pulses of 1 Hz active rTMS daily on 10 consecutive work days.
    Intervention: Device: repetitive transcranial magnetic stimulation (rTMS)
  • Sham Comparator: Arm 2
    Half of the study participants will receive 2000 pulses of 1 Hz placebo rTMS daily on 10 consecutive work days.
    Intervention: Device: placebo rTMS
Folmer RL, Theodoroff SM, Casiana L, Shi Y, Griest S, Vachhani J. Repetitive Transcranial Magnetic Stimulation Treatment for Chronic Tinnitus: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Aug;141(8):716-22. doi: 10.1001/jamaoto.2015.1219.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2016
December 2016   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01104207
C7448-I
No
Not Provided
Plan to Share IPD: No
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Robert Folmer, PhD VA Portland Health Care System, Portland, OR
VA Office of Research and Development
February 2017

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