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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham rTMS - Sham repetitive transcranial magnetic stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria per protocol and informed consent:
Exclusion Criteria per protocol and informed consent:
For rTMS
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| Name | Affiliation | Role |
|---|---|---|
| Mark Mennemeier, PhD | UAMS Department of Neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Of the 58 subjects enrolled, only 39 were assigned to study groups. Two subjects who initially failed screening were re-enrolled via a waiver before assignment. Ten had participated in an early version of the protocol that was not comparable. Seven subjects dropped out after baseline. So 2+10+7= the 19 participants who were enrolled but not started in the participant flow.
A total of 58 participants were enrolled. Recruitment used a waitlist of subjects who already expressed interest in tinnitus studies and from advertisement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Followed by Active 1Hz Then 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. Sham rTMS Active 1 Hz rTMS Active 1 Hz rTMS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2017 |
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| Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency | Device | 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. |
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| Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency | Device | 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. |
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| FG001 | Sham Followed by Active 10Hz Then 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. Sham rTMS Active 1 Hz rTMS Active 10 Hz rTMS |
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Numbers are reported for all persons enrolled in the study, not just those for subjects who were assigned to a treatment arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Enrolled in the Study | Baseline information is reported for all subjects enrolled. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline analogue ratings of tinnitus awareness | Baseline ratings are the average of the baseline assessments on separate days. Analogue ratings of tinnitus awareness range from 0 (no tinnitus) to 100 (painfully loud tinnitus). | Baseline ratings are reported only for the 39 subjects who were assigned to a treatment arm and completed all baseline assessments | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 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). |
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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.
While it was possible to accurately report Adverse Events by assigned Arm, it was not possible to accurately report adverse events by rTMS frequency because the majority of adverse events (49/58) were not study related. Rather they included illness or injuries that occurred outside the study in daily life. Only 9/58 adverse events were coded as study related and these are described in the Adverse Event Additional Description field.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Who Received Sham Followed by Active 1 Hz rTMS Then Active 10 Hz rTMS. | Subjects in this arm received a course of sham stimulation which was followed by a course of active stimulation at 1 Hz rTMS and then a course of active stimulation at 10 Hz. | 1 | 27 | 1 | 27 | 12 | 27 |
| EG001 | Subjects Who Received Sham Followed by Active 10 Hz rTMS Then Active 1 Hz rTMS | Subjects in this arm received a course of sham stimulation which was followed by a course of active stimulation at 10 Hz rTMS and then a course of active stimulation at 1 Hz. | 0 | 31 | 0 | 31 | 8 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | Drowning. Not study related. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Skin and subcutaneous tissue disorders | Systematic Assessment | In the 1 Hz first arm 4/4 reports of headache were coded as related to the study intervention; whereas in the 10 Hz first arm 1/4 reports of headache were study related. |
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| Jaw pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | In the 1 Hz first arm 3/3 reports of jaw pain were coded as related to the study intervention; whereas in the 10 Hz first arm 0/1 reports were study related. |
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| Tinnitus increase | Nervous system disorders | Systematic Assessment | In the 1 Hz first arm 1/1 reports of tinnitus increase were coded as related to the study intervention; whereas in the 10 Hz first arm there were no such reports. |
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| Illness | General disorders | Systematic Assessment | reported illness not due to intervention (Flu, orthopedic, back pain, injury) |
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| eye muscle twitching | Eye disorders | Systematic Assessment | report of eye muscles twitching after intevention |
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| Increase heart rate | Cardiac disorders | Systematic Assessment | Report of increase heart rate prior to session. |
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Limited recruitment and retention into maintenance (n=3 with complete data) precluded meaningful data analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mark Mennemeier | University of Arkansas for Medical Sciences | 205 410 2413 | msmennemeier@uams.edu |
| Oct 1, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| .02 |
t value = -2.03 |
| Mean Difference (Final Values) |
| -6.77 |
| 1-Sided |
10 Hz active rTMS - Sham rTMS |
| Superiority |
| Mixed Models Analysis | .20 | t value = -1..28 | Mean Difference (Final Values) | -4.73 | 1-Sided | 10 Hz washout - sham washout period | Superiority |
| Mixed Models Analysis | .19 | t value = -1.29 | Mean Difference (Final Values) | -5.19 | 1-Sided | 1Hz washout - sham washout | Superiority |