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Transcranial Magnetic Stimulation for Tinnitus

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ClinicalTrials.gov Identifier: NCT01104207
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : February 23, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE April 13, 2010
First Posted Date  ICMJE April 15, 2010
Results First Submitted Date  ICMJE January 4, 2017
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
Tinnitus Handicap Inventory score [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
Tinnitus loudness [ Time Frame: 1, 2, 4, 13 and 26 weeks post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Magnetic Stimulation for Tinnitus
Official Title  ICMJE Clinical Trial of Transcranial Magnetic Stimulation for Relief of Tinnitus
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2010)
168
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01104207
Other Study ID Numbers  ICMJE C7448-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Folmer, PhD VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date February 2017

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