TinnitusPhase 2NCT00886938
rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study in people with Tinnitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The neurological basis of tinnitus is uncertain when there is no evidence of damage to the peripheral auditory system. However, neuroimaging studies of tinnitus patients show hyperactivity in several cortical regions, especially the auditory cortices and middle temporal regions. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 2010
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be between the ages of 18 and 60 years.
- Subjective, idiopathic, troublesome, unilateral or bilateral, non-pulsatile tinnitus of ≥ 6 month's duration..
- Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.
- Must be able to understand, speak, read, and write English proficiently
- Able to provide informed consent
Who cannot join
- Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone. Patients with a history of stapedectomy and insertion of implant may be included if their prosthesis is magnetically safe (MRI compatible up to and including 3T). Patient must be able to provide documentation from surgeon regarding manufacturer information of prosthesis before they will be considered into study.
- Hypersensitive to noises (hyperacusis)
- Patients with cardiac pacemakers; intracardiac lines; implanted medication pumps; implanted electrodes in the brain; other implanted electrical or magnetic medical devices; or other intracranial metal objects or shrapnel, with the exception of dental fillings and MRI compatible stapedectomies or any other contraindication for MRI scan
- Patients with additional significant neurological disorders including increased intracranial pressure, brain mass, epileptic seizures (or family history of epileptic seizures), history of stroke, transient ischemic attack within 2 years, cerebral aneurysm, Huntington's chorea or multiple sclerosis.
- Patients with an acute or unstable medical condition including all patients with any significant heart disease, heart murmur, pneumonia, acute GI bleed, uncontrolled hypertension, or other disorders which would require stabilization prior to initiation of transcranial magnetic stimulation.
- Active alcohol and/or drug dependence or history of alcohol and/or drug dependence within the last year.
Show all 16Show fewer
- Patients with clinical depression as evidenced by a score of 18 or greater on the Beck Depression Inventory98 or who or, in the opinion of the psychiatric sub-investigator demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive Disorder
- Patients with psychological illness or trauma which would prohibit participation in the study.
- Female patients of child-bearing potential, unless sterilized or using an appropriate form of birth control acceptable to the research team.
- Currently breastfeeding
- Currently pregnant
- Patients will be excluded if a motor threshold cannot be elicited
- Patients who or are taking over-the-counter or prescribed medication administered for the treatment of any psychiatric or neurologic disorder or any other known CNS active drugs, including herbal, over-the-counter, and homeopathic medications, MAOIs, other antidepressants, antipsychotics, and mood stabilizers.
- Patients whose ability to give informed consent is in question
- Undiagnosed symptomatic hypertension: (for this study defined as systolic blood pressures above 140 mm or diastolic pressure above 90 mm). Subject will be referred to their PCP and not allowed to continue in screening without a note from the PCP stating that they are under his care and have been asymptomatic and with subject's hypertension controlled for at least 3 months.
- Undiagnosed asymptomatic hypertension: (for this study defined as systolic blood pressures above 140 mm or diastolic pressure above 90 mm). Subject will be allowed to continue in the screening process at the discretion of the PI. However, the subject will be referred to his PCP and not allowed to start treatment without a note from his PCP stating that either he was evaluated and his blood
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The neurological basis of tinnitus is uncertain when there is no evidence of damage to the peripheral auditory system. However, neuroimaging studies of tinnitus patients show hyperactivity in several cortical regions, especially the auditory cortices and middle temporal regions. A potentially promising treatment modality for tinnitus is repetitive transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas of the brain. When the magnetic device is placed on the skull, the resultant magnetic field passes through the skull and induces a small secondary current in the cortex. It has been hypothesized that the effect of the frequency used in rTMS differentially influences cortical activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation (10-20 Hz) increasing cortical activity.
Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation of the left auditory cortex, an area that has been demonstrated to be hyperactive in tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however. Converging data implicate structures of the brain that are important for mood and attention as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment approach that targets these structures. A growing number of studies demonstrate involvement of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal cortex has been shown to increase the durability of the TPC stimulation. The independent effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that increasing the intensity and duration of stimulation has beneficial treatment effects. However, the field is new and more work is needed to assess the effectiveness of this treatment, predictors and correlates of response, and safety.
Herein, we propose an open-label pilot study investigating the effectiveness of rTMS stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and attention, in the treatment of tinnitus
Read the detailed description
See description above.
- Conditions
- Tinnitus
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study
- Keywords
- tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS), pilot studyDevice
Also called Tinnitus, rTMS, Dorsolateral Prefrontal Cortex, DLPF
Repetitive transcranial magnetic stimulation, pilot study
| Study group | Role | What they receive |
|---|---|---|
| rTMS to DLPF, pilot study | Experimental | rTMS to the dorsolateral prefrontal cortex for patients with tinnitus Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)
Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.
Measured: 0,4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2010
- Study completionAug 2010
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 Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay F Piccirillo, MD,CPI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886938
- Sponsor's protocol ID
- 09-0551
- Status last verified
- May 2014
- First submitted
- 22 Apr 2009
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS To The Dorsolateral Prefrontal Cortex For Patients With Subjective Idiopathic Tinnitus. A Pilot Study
- ClinicalTrials.gov ID
- NCT00886938
- Acronym / sponsor ID
- 09-0551
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 21 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The neurological basis of tinnitus is uncertain when there is no evidence of damage to the peripheral auditory system. However, neuroimaging studies of tinnitus patients show hyperactivity in several cortical regions, especially the auditory cortices and middle temporal regions. A potentially promising treatment modality for tinnitus is repetitive transcranial magnetic stimulation (rTMS). rTMS involves the application of frequent, repeated magnetic stimuli to the skull to induce electrical activity in the underlying cortical areas of the brain. When the magnetic device is placed on the skull, the resultant magnetic field passes through the skull and induces a small secondary current in the cortex. It has been hypothesized that the effect of the frequency used in rTMS differentially influences cortical activity with low-frequency (1Hz) stimulation decreasing and high-frequency stimulation (10-20 Hz) increasing cortical activity.
Currently, reports on treating tinnitus with rTMS have focused on low-frequency stimulation of the left auditory cortex, an area that has been demonstrated to be hyperactive in tinnitus. The benefits of low-frequency auditory cortex stimulation are time limited however. Converging data implicate structures of the brain that are important for mood and attention as playing a role in the maintenance of tinnitus; suggesting an alternative rTMS treatment approach that targets these structures. A growing number of studies demonstrate involvement of the prefrontal cortex in the generation and maintenance of tinnitus. rTMS stimulation in the dorsolateral prefrontal cortex in association with stimulation in the temporoparietal cortex has been shown to increase the durability of the TPC stimulation. The independent effect of rTMS stimulation to the DLPFC is not known. Studies in depression suggest that increasing the intensity and duration of stimulation has beneficial treatment effects. However, the field is new and more work is needed to assess the effectiveness of this treatment, predictors and correlates of response, and safety.
Herein, we propose an open-label pilot study investigating the effectiveness of rTMS stimulation of the dorsolateral prefrontal cortex, an area known to be important for mood and attention, in the treatment of tinnitus
Detailed description
See description above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS to DLPF, pilot study | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), pilot studyrTMS to the dorsolateral prefrontal cortex for patients with tinnitus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be between the ages of 18 and 60 years.
- Subjective, idiopathic, troublesome, unilateral or bilateral, non-pulsatile tinnitus of ≥ 6 month's duration..
- Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.
- Must be able to understand, speak, read, and write English proficiently
- Able to provide informed consent
Key exclusion criteria (16 listed)
- Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone. Patients with a history of stapedectomy and insertion of implant may be included if their prosthesis is magnetically safe (MRI compatible up to and including 3T). Patient must be able to provide documentation from surgeon regarding manufacturer information of prosthesis before they will be considered into study.
- Hypersensitive to noises (hyperacusis)
- Patients with cardiac pacemakers; intracardiac lines; implanted medication pumps; implanted electrodes in the brain; other implanted electrical or magnetic medical devices; or other intracranial metal objects or shrapnel, with the exception of dental fillings and MRI compatible stapedectomies or any other contraindication for MRI scan
- Patients with additional significant neurological disorders including increased intracranial pressure, brain mass, epileptic seizures (or family history of epileptic seizures), history of stroke, transient ischemic attack within 2 years, cerebral aneurysm, Huntington's chorea or multiple sclerosis.
- Patients with an acute or unstable medical condition including all patients with any significant heart disease, heart murmur, pneumonia, acute GI bleed, uncontrolled hypertension, or other disorders which would require stabilization prior to initiation of transcranial magnetic stimulation.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS), pilot studyAlso: Tinnitus, rTMS, Dorsolateral Prefrontal Cortex, DLPFRepetitive transcranial magnetic stimulation, pilot study | Device | rTMS to DLPF, pilot study |
Primary outcome
Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)
Time frame: 0,4 weeks
Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- 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.
Jay F Piccirillo, MD,CPI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repetitive Transcranial Magnetic Stimulation (rTMS), pilot study in people with Tinnitus, run by Washington University School of Medicine at 1 site in United States.
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 5 inclusion and 16 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 16 May 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2012). 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?
Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI) (time frame: 0,4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2014.