NCT01104207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

5.8 years

First QC Date

April 13, 2010

Results QC Date

January 4, 2017

Last Update Submit

February 27, 2017

Conditions

Tinnitus

Keywords

tinnitusTMStranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    26 weeks post-treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Half of the study participants will receive 2000 pulses of 1 Hz active rTMS daily on 10 consecutive work days.

Device: repetitive transcranial magnetic stimulation (rTMS)

Arm 2

SHAM COMPARATOR

Half of the study participants will receive 2000 pulses of 1 Hz placebo rTMS daily on 10 consecutive work days.

Device: placebo rTMS

Interventions

repetitive transcranial magnetic stimulation (rTMS)DEVICE

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.

Arm 1
placebo rTMSDEVICE

placebo rTMS

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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.

    PMID: 28183355DERIVED

  • 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.

    PMID: 26181507DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Robert L. Folmer, Ph.D.
Organization
VA Portland Medical Center
Robert.Folmer@va.gov
503-220-8262

Study Officials

  • Robert Folmer, PhD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

March 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 29, 2017

Results First Posted

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)