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Effect of rTMS on Resting State Brain Activity in Tinnitus

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ClinicalTrials.gov Identifier: NCT00926237
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE June 19, 2009
First Posted Date  ICMJE June 23, 2009
Results First Submitted Date  ICMJE October 5, 2020
Results First Posted Date  ICMJE November 20, 2020
Last Update Posted Date November 20, 2020
Actual Study Start Date  ICMJE January 2009
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
Change From Baseline on the Analogue Rating of Tinnitus Awareness. [ 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). ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
  • Change in tinnitus perception, as measured over time using a subjective visual analog rating scale [ Time Frame: At subject enrollment, before and after each active or sham rTMS session, and via daily tinnitus log lasting for up to 6 months following rTMS therapy ]
  • Change in metabolic activity from pre-treatment to post-treatment PET-CT brain scans for the brain regions targeted with rTMS therapy, calculated as the difference of the asymmetry ratios for each. [ Time Frame: PET-CT scans obtained before and immediately following the first week of rTMS therapy (sham and active) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2009)
  • Change in hearing threshold [ Time Frame: Audiology evaluations obtained before and after the initial two weeks of rTMS therapy ]
  • Change in psychomotor vigilance testing (PVT) [ Time Frame: PVT data obtained at the beginning and the end of each week of rTMS therapy ]
  • Change in Beck's Depression Inventory (BDI) [ Time Frame: BDI data obtained at the beginning and the end of each week of rTMS therapy ]
  • Change in Tinnitus Severity Index (TSI) [ Time Frame: TSI data obtained at the beginning and the end of each week of rTMS therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of rTMS on Resting State Brain Activity in Tinnitus
Official Title  ICMJE Effect of rTMS on Resting State Brain Activity in Tinnitus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Device: Sham rTMS - Sham repetitive transcranial magnetic stimulation
    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.
  • Device: Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency
    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.
  • Device: Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
    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.
Study Arms  ICMJE
  • Experimental: Sham followed by active 1Hz, then active 10Hz rTMS
    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.
    Interventions:
    • Device: Sham rTMS - Sham repetitive transcranial magnetic stimulation
    • Device: Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency
    • Device: Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
  • Experimental: Sham followed by active 10Hz and active 1Hz rTMS
    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.
    Interventions:
    • Device: Sham rTMS - Sham repetitive transcranial magnetic stimulation
    • Device: Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency
    • Device: Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
Publications * Not Provided

*   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: November 17, 2020)
58
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2009)
10
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 89 Years   (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 NCT00926237
Other Study ID Numbers  ICMJE 109033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Mark Mennemeier, PhD UAMS Department of Neurosciences
PRS Account University of Arkansas
Verification Date November 2020

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