TinnitusNCT00926237

Effect of rTMS on Resting State Brain Activity in Tinnitus

A study testing Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency and Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency in people with Tinnitus, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 19 to 89 years
Conditions the study is for: Tinnitus
What is being tested?: Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency and Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205

Other trials in United States

About this study

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.

Read the 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.

Conditions: Tinnitus
Being tested: 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
Keywords: Tinnitus, Transcranial Magnetic Stimulation, TMS, rTMS
Medical subject headings: Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham rTMS - Sham repetitive transcranial magnetic stimulationDevice
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 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequencyDevice
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 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequencyDevice
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 groups in NCT00926237
Study group	Role	What they receive
Sham followed by active 1Hz, then active 10Hz rTMS	Experimental	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. Receives: 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
Sham followed by active 10Hz and active 1Hz rTMS	Experimental	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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Sep 2019

First posted23 Jun 2009 (estimated)
Study startJan 2009
Primary completionSep 2019
Study completionSep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TinnitusStudies of the same condition, open and under way.
More trials run by University of ArkansasThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00926237
Sponsor's protocol ID: 109033
Status last verified: Nov 2020
First submitted: 19 Jun 2009
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus

All Tinnitus trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of rTMS on Resting State Brain Activity in Tinnitus
ClinicalTrials.gov ID: NCT00926237
Acronym / sponsor ID: 109033
Conditions: Tinnitus
Keywords: Tinnitus, Transcranial Magnetic Stimulation, TMS, rTMS
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Jan 2009 (actual)
Primary completion: Sep 2019 (actual)
Study completion: Sep 2019 (actual)
First posted: 23 Jun 2009 (estimated)
Results: Posted 20 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham followed by active 1Hz, then active 10Hz rTMS	Experimental	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 frequencySubjects 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	Experimental	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 frequencySubjects 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.

Who may qualify

Ages: 19 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sham rTMS - Sham repetitive transcranial magnetic stimulationSham 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	Sham followed by active 10Hz and active 1Hz rTMS, Sham followed by active 1Hz, then active 10Hz rTMS
Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequencyActive 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	Sham followed by active 10Hz and active 1Hz rTMS, Sham followed by active 1Hz, then active 10Hz rTMS
Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequencyActive 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.	Device	Sham followed by active 10Hz and active 1Hz rTMS, Sham followed by active 1Hz, then active 10Hz rTMS

Primary outcome

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.

Results and safety

Results posted to the registry on 20 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Followed by Active 1Hz Then 10Hz rTMS	19	17
Sham Followed by Active 10Hz Then 1Hz rTMS	20	19

Primary outcome: 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).. Mean (Standard Error). Unit: units on a scale

Measure	Sham rTMS n = 36	Sham Washout n = 36	1 Hz Active rTMS n = 36	1 Hz Washout n = 36	10 Hz Active rTMS n = 36	10 Hz Washout n = 36
Value	-4.08 (3.72)	-4.70 (3.90)	-9.82 (3.72)	-9.89 (3.91)	-10.85 (3.85)	-9.43 (4.06)

Sham rTMS vs 1 Hz Active rTMS: Mean Difference (Final Values): -5.74, p = .04, Mixed Models Analysis
Sham rTMS vs 10 Hz Active rTMS: Mean Difference (Final Values): -6.77, p = .02, Mixed Models Analysis
Sham Washout vs 10 Hz Washout: Mean Difference (Final Values): -4.73, p = .20, Mixed Models Analysis

Population analysed: The analysis population includes 36 subjects who completed the all baseline, sham rTMS, sham washout, active 1 Hz rTMS, 1Hz washout, active 10Hz rTMS and 10Hz washout periods.

Adverse events

Time frame: Adverse event data were collected from baseline until study completion at followup: ~113 days for participants who did not enter maintenance and up to ~159 days for subjects who entered maintenance.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Who Received Sham Followed by Active 1 Hz rTMS Then Active 10 Hz rTMS.	1 of 27 (3.7%)	12 of 27 (44.4%)	1 of 27
Subjects Who Received Sham Followed by Active 10 Hz rTMS Then Active 1 Hz rTMS	0 of 31 (0%)	8 of 31 (25.8%)	0 of 31

Limitations and caveats (from the sponsor): Limited recruitment and retention into maintenance (n=3 with complete data) precluded meaningful data analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tinnitus

Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Mennemeier, PhD principal investigator

UAMS Department of Neurosciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00926237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.