TinnitusNCT00329524
Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Tinnitus, run by University of Arkansas at 1 site in United States.
Trial summary
One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right-handed subjects
- 19-65 years of age
- debilitating unilaterial or bilateral tinnitus
- Experiencing the presence of phantom auditory preception for >6 months
- Tinnitus Handicap Questionnaire score of >30
Who cannot join
- significant neurological disease
- acoustic neuromas or glomus tumors
- active Meniere's disease
- profound hearing loss
- non English speaking
- personal or family history of epilepsy
Show all 11Show fewer
- personal history of head injury, aneurysm, stroke, previous cranial neurosurgery, neurological or psychiatric disorders, metal implants in the head or neck, a pacemaker, pregnancy, migraines,
- medications that lower seizure threshold and are contraindicated
- individuals who have been taking certain medications
- claustrophobia
- patients who do not exhibit significant cortical asymmetries on PET
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus.
This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.
Read the detailed description
Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the presence of their phantom auditory perception for at least 6 months and have a Tinnitus Handicap Questionnaire (THQ) score >30. Subjects will be recruited from the Otolaryngology Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy. Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or any other central nervous system pathology. All subjects will be thoroughly informed of the risks associated with the procedures in this study, as described in the Hazards to Subjects section, and written informed consent will be obtained. Subjects will be recruited for this study without regard to race or ethnicity.
- Conditions
- Tinnitus
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Tinnitus, TMS, Transcranial Magnetic Stimulation
- 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)Device
TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Active versus Sham Treatment | Sham comparator | Subjects randomly assigned to active and sham TMS separated by one week interval. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PET Asymmetry Index
Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
Measured: After active treatment week
Secondary outcomes (2)
Psychomotor Vigilance
Change in simple auditory reaction time after treatment
Measured: Immediately after treatment
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
Rating of tinnitus loudness using a scale of 0-100 for
Measured: immediately following active and sham TMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionAug 2008
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Tinnitus Research Consortium
- Responsible party
- Sponsor
- Investigators
- John Dornhoffer, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329524
- Sponsor's protocol ID
- 51817
- Status last verified
- Apr 2015
- First submitted
- 22 May 2006
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smith JA, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a pilot study. Laryngoscope. 2007 Mar;117(3):529-34. doi: 10.1097/MLG.0b013e31802f4154.
PubMed 17334317Richter GT, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a case study. Laryngoscope. 2006 Oct;116(10):1867-72. doi: 10.1097/01.mlg.0000234936.82619.69.
PubMed 17016213
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus
- ClinicalTrials.gov ID
- NCT00329524
- Acronym / sponsor ID
- 51817
- Conditions
- Tinnitus
- Keywords
- Tinnitus, TMS, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Tinnitus Research Consortium
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 May 2006 (estimated)
- Results
- Posted 7 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One out of every five people experience tinnitus (a buzzing, ringing, or roaring sound in the ear) ranging from mild to severe impairment. To date there is no effective therapy that seems to help the tinnitus sufferer. The purpose of this study is to develop a therapy using a technique called Repetitive Transcranial Magnetic Stimulation (rTMS) to hopefully alleviate or reduce the symptoms of tinnitus.
This research is being conducted at the University of Arkansas for Medical Sciences (UAMS). Up to twenty (20) right handed subjects, either males or females, 19-65 years of age, with tinnitus that is severe enough for those persons to seek medical attention will have been seen as patients in the UAMS Hearing and Balance Center, where routine testing includes a physical exam, hearing tests, evaluation of middle ear status, and an MRI scan (a machine that acquires visual images of the brain). A diagnosis of tinnitus will be established after ruling out all other possible causes of the tinnitus.
Detailed description
Subjects will be up to 20 right-handed patients (men and women), 19-65 years of age, with debilitating unilateral or bilateral tinnitus. All subjects must report experiencing the presence of their phantom auditory perception for at least 6 months and have a Tinnitus Handicap Questionnaire (THQ) score >30. Subjects will be recruited from the Otolaryngology Clinic at UAMS, where routine testing includes a physical exam; pure tone audiometry; and evaluation of middle ear status using tympanometry, stapedius reflex tests, and otoscopy. Patients will undergo a gadolinium-contrast MRI of the head to rule out acoustic neuroma or any other central nervous system pathology. All subjects will be thoroughly informed of the risks associated with the procedures in this study, as described in the Hazards to Subjects section, and written informed consent will be obtained. Subjects will be recruited for this study without regard to race or ethnicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active versus Sham Treatment | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Subjects randomly assigned to active and sham TMS separated by one week interval. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- right-handed subjects
- 19-65 years of age
- debilitating unilaterial or bilateral tinnitus
- Experiencing the presence of phantom auditory preception for >6 months
- Tinnitus Handicap Questionnaire score of >30
Key exclusion criteria (11 listed)
- significant neurological disease
- acoustic neuromas or glomus tumors
- active Meniere's disease
- profound hearing loss
- non English speaking
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)TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if a maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectively, 7 days following the completion of the first treatment session. | Device | Active versus Sham Treatment |
Primary outcome
Change in PET Asymmetry Index
Time frame: After active treatment week
Change in calculated PET asymmetry index between left and right temporal lobe from baseline following active Tx
2 secondary outcomes
Psychomotor Vigilance
Time frame: Immediately after treatment
Difference in Visual Analog Rating of Tinnitus (VAR)Following Active and Sham Tx
Time frame: immediately following active and sham TMS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17334317Smith JA, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a pilot study. Laryngoscope. 2007 Mar;117(3):529-34. doi: 10.1097/MLG.0b013e31802f4154.
- Results publication: PubMed 17016213Richter GT, Mennemeier M, Bartel T, Chelette KC, Kimbrell T, Triggs W, Dornhoffer JL. Repetitive transcranial magnetic stimulation for tinnitus: a case study. Laryngoscope. 2006 Oct;116(10):1867-72. doi: 10.1097/01.mlg.0000234936.82619.69.
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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.
John Dornhoffer, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Tinnitus, run by University of Arkansas 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 11 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 4 May 2015. 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. Some participants in this study may receive a placebo. 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 7 Aug 2009). 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 in PET Asymmetry Index (time frame: After active treatment week). 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 NCT00329524, which also lists 2 linked publications.
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 4 May 2015.