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Effect of rTMS on Resting State Brain Activity in Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham rTMS - Sham repetitive transcranial magnetic stimulation
Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency
Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Transcranial Magnetic Stimulation, TMS, rTMS

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria per protocol and informed consent:

  • Diagnosis of tinnitus established through a history and physical exam or review of records.
  • Subjects 19-89 years of age
  • Tinnitus present for at least 6 months and severe enough to seek medical attention
  • Subjects taking SSRI's (a class of anti-depressant medications)and benzodiazepines (a class of anti-anxiety medications) for depression or anxiety related to tinnitus must be stable on their current dose for at least 3 months and must not alter their dose or medication during their involvement with this study
  • Subjects must agree to avoid consuming alcohol within 72 hours of each rTMS session
  • Female subjects of childbearing potential must demonstrate a negative pregnancy test during their initial clinic visit and must agree to use effective contraception during their participation in this study
  • Subjects must sign an informed consent and agree to comply with study and follow-up procedures, including completion of all necessary questionnaires and testing, as well as, being video-recorded for safety purposes during rTMS sessions
  • Subjects must speak and comprehend English adequately to understand and complete any study-related instructions and questionnaires

Exclusion Criteria per protocol and informed consent:

For rTMS

  • Subjects or any of their 1st-degree relatives must not have been diagnosed with epilepsy
  • Subjects must not have a history of seizure disorder or migraines
  • Subjects must not have any history of a brain aneurysm, stroke, previous cranial neurosurgery, acoustic neuroma, glomus tumor, active Menniere's Disease, profound hearing loss (greater than 90 dB at 4000 Hz), or any major neurological or psychiatric disorders (excluding depression or anxiety related to tinnitus)
  • Medications that lower seizure threshold or reduce cortical excitation (i.e., tricyclic antidepressants, bupropion or anticonvulsants)
  • Subjects must not have any history of a head injury that resulted in a loss of consciousness for more than 10 minutes
  • Subjects must not be pregnant or refuse to utilize effective contraception during their participation in this study For MRI
  • Subjects must not have any metal implants or devices in the head or neck or a pacemaker.
  • Subjects must not have severe claustrophobia if they are to have an MRI.
  • Significant abnormalities must not be present on acquired or existing CT or MRI image of the head.

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sham followed by active 1Hz, then active 10Hz rTMS

Sham followed by active 10Hz and active 1Hz rTMS

Arm Description

Subjects assigned to this arm received sham rTMS followed by active rTMS at 1Hz and then active rTMS at 10 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.

Subjects assigned to this arm received sham rTMS followed by active rTMS at 10 Hz and then active rTMS at 1 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.

Outcomes

Primary Outcome Measures

Change From Baseline on the Analogue Rating of Tinnitus Awareness.
Change from baseline on the daily analogue rating of tinnitus awareness. Analogue ratings are a validated self report instrument assessing subjects awareness of tinnitus in daily life. Possible scores range from 0 (no tinnitus) to 100 (painfully loud tinnitus). Change equals the average rating for a given treatment week or washout period minus the average rating over three baseline assessments.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2009
Last Updated
November 17, 2020
Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00926237
Brief Title
Effect of rTMS on Resting State Brain Activity in Tinnitus
Official Title
Effect of rTMS on Resting State Brain Activity in Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus awareness. The purpose of this study is to evaluate a treatment option for tinnitus that uses a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which could prove to be an effective means of alleviating or reducing the symptoms of tinnitus.
Detailed Description
Up to 60 subjects, including males and females ages 19-89 years old and of all races, and with tinnitus severe enough to seek medical attention, will be enrolled in this study. All participants must be evaluated or have documentation of being evaluated prior to beginning therapy with rTMS in order to confirm eligibility and to rule out any medically treatable causes of tinnitus. An MRI scan of the head may or may not be required, depending upon the results of this evaluation, in order to rule out specific middle ear pathologies. This study will require participation in at least three weeks (4 weekdays per week) of rTMS sessions, including two active weeks and a sham (or placebo) week. There will be a three week washout period following each treatment week. At the completion of the three treatment weeks, subjects who have noticed an improvement in their tinnitus will have the option of participating in a maintenance rTMS program providing up to 8 additional weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Transcranial Magnetic Stimulation, TMS, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham followed by active 1Hz, then active 10Hz rTMS
Arm Type
Experimental
Arm Description
Subjects assigned to this arm received sham rTMS followed by active rTMS at 1Hz and then active rTMS at 10 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Arm Title
Sham followed by active 10Hz and active 1Hz rTMS
Arm Type
Experimental
Arm Description
Subjects assigned to this arm received sham rTMS followed by active rTMS at 10 Hz and then active rTMS at 1 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Intervention Type
Device
Intervention Name(s)
Sham rTMS - Sham repetitive transcranial magnetic stimulation
Intervention Description
Sham rTMS will be delivered using a commercially available sham coil and targeted to the same brain site in the temporal lobe and in a manner identical to that for active rTMS except that scalp electrodes are used to stimulate the temporalis muscle electrically during sham stimulation to replicate the feel of active TMS.
Intervention Type
Device
Intervention Name(s)
Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency
Intervention Description
Active rTMS will be targeted either to the mid-superior temporal gyrus opposite the ear with loudest tinnitus or to the same region in the left hemisphere if no asymmetry in tinnitus is present. 1 Hz active rTMS will be delivered at 110% of motor threshold (MT) for a total of 1800 magnetic pulses per session, 4 sessions per week.
Intervention Type
Device
Intervention Name(s)
Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
Intervention Description
Active rTMS will be targeted either to the mid-superior temporal gyrus opposite the ear with loudest tinnitus or to the same region in the left hemisphere if no asymmetry in tinnitus is present. 10 Hz active rTMS will be delivered at 110% of motor threshold (MT) for a total of 1800 magnetic pulses per session, 4 sessions per week.
Primary Outcome Measure Information:
Title
Change From Baseline on the Analogue Rating of Tinnitus Awareness.
Description
Change from baseline on the daily analogue rating of tinnitus awareness. Analogue ratings are a validated self report instrument assessing subjects awareness of tinnitus in daily life. Possible scores range from 0 (no tinnitus) to 100 (painfully loud tinnitus). Change equals the average rating for a given treatment week or washout period minus the average rating over three baseline assessments.
Time Frame
from baseline to: day 6 (sham), day 25 (sham w/o), day 29 (1st active TX), day 50 (1st active w/o), day 50 (2nd active TX), day 76 (2nd active w/o).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria per protocol and informed consent: Diagnosis of tinnitus established through a history and physical exam or review of records. Subjects 19-89 years of age Tinnitus present for at least 6 months and severe enough to seek medical attention Subjects taking SSRI's (a class of anti-depressant medications)and benzodiazepines (a class of anti-anxiety medications) for depression or anxiety related to tinnitus must be stable on their current dose for at least 3 months and must not alter their dose or medication during their involvement with this study Subjects must agree to avoid consuming alcohol within 72 hours of each rTMS session Female subjects of childbearing potential must demonstrate a negative pregnancy test during their initial clinic visit and must agree to use effective contraception during their participation in this study Subjects must sign an informed consent and agree to comply with study and follow-up procedures, including completion of all necessary questionnaires and testing, as well as, being video-recorded for safety purposes during rTMS sessions Subjects must speak and comprehend English adequately to understand and complete any study-related instructions and questionnaires Exclusion Criteria per protocol and informed consent: For rTMS Subjects or any of their 1st-degree relatives must not have been diagnosed with epilepsy Subjects must not have a history of seizure disorder or migraines Subjects must not have any history of a brain aneurysm, stroke, previous cranial neurosurgery, acoustic neuroma, glomus tumor, active Menniere's Disease, profound hearing loss (greater than 90 dB at 4000 Hz), or any major neurological or psychiatric disorders (excluding depression or anxiety related to tinnitus) Medications that lower seizure threshold or reduce cortical excitation (i.e., tricyclic antidepressants, bupropion or anticonvulsants) Subjects must not have any history of a head injury that resulted in a loss of consciousness for more than 10 minutes Subjects must not be pregnant or refuse to utilize effective contraception during their participation in this study For MRI Subjects must not have any metal implants or devices in the head or neck or a pacemaker. Subjects must not have severe claustrophobia if they are to have an MRI. Significant abnormalities must not be present on acquired or existing CT or MRI image of the head.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mennemeier, PhD
Organizational Affiliation
UAMS Department of Neurosciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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