Transcranial Magnetic Stimulation for Tinnitus
Primary Purpose
Tinnitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS)
placebo rTMS
Sponsored by
About this trial
This is an interventional other trial for Tinnitus focused on measuring tinnitus, TMS, transcranial magnetic stimulation
Eligibility Criteria
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.
Sites / Locations
- VA Portland Health Care System, Portland, OR
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Half of the study participants will receive 2000 pulses of 1 Hz active rTMS daily on 10 consecutive work days.
Half of the study participants will receive 2000 pulses of 1 Hz placebo rTMS daily on 10 consecutive work days.
Outcomes
Primary Outcome Measures
Change in Tinnitus Functional Index (TFI) Score
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01104207
First Posted
April 13, 2010
Last Updated
February 27, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01104207
Brief Title
Transcranial Magnetic Stimulation for Tinnitus
Official Title
Clinical Trial of Transcranial Magnetic Stimulation for Relief of Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, TMS, transcranial magnetic stimulation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Half of the study participants will receive 2000 pulses of 1 Hz active rTMS daily on 10 consecutive work days.
Arm Title
Arm 2
Arm Type
Sham Comparator
Arm Description
Half of the study participants will receive 2000 pulses of 1 Hz placebo rTMS daily on 10 consecutive work days.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
placebo rTMS
Intervention Description
placebo rTMS
Primary Outcome Measure Information:
Title
Change in Tinnitus Functional Index (TFI) Score
Description
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.
Time Frame
26 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Folmer, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28183355
Citation
Theodoroff SM, Griest SE, Folmer RL. Transcranial magnetic stimulation for tinnitus: using the Tinnitus Functional Index to predict benefit in a randomized controlled trial. Trials. 2017 Feb 9;18(1):64. doi: 10.1186/s13063-017-1807-9.
Results Reference
derived
PubMed Identifier
26181507
Citation
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.
Results Reference
derived
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Transcranial Magnetic Stimulation for Tinnitus
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