Effect of rTMS on Resting State Brain Activity in Tinnitus
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 19, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
November 20, 2020
CompletedNovember 20, 2020
November 1, 2020
10.7 years
June 19, 2009
October 5, 2020
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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).
Study Arms (2)
Sham followed by active 1Hz, then active 10Hz rTMS
EXPERIMENTALSubjects 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.
Sham followed by active 10Hz and active 1Hz rTMS
EXPERIMENTALSubjects 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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arkansaslead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limited recruitment and retention into maintenance (n=3 with complete data) precluded meaningful data analysis.
Results Point of Contact
- Title
- Dr Mark Mennemeier
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Mennemeier, PhD
UAMS Department of Neurosciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2009
First Posted
June 23, 2009
Study Start
January 1, 2009
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
November 20, 2020
Results First Posted
November 20, 2020
Record last verified: 2020-11