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| ID | Type | Description | Link |
|---|---|---|---|
| R21DC015880 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The purpose of this research is to understand how a neuromodulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic tinnitus measured with functional magnetic resonance imaging (fMRI). We hypothesize that multiple sessions of tES (5 consecutive days) will modulate:
In exploratory analyses, we also measure the extent to which the hypothesized changes listed above a related to changes in tinnitus symptoms after tES.
Chronic subjective tinnitus is a common and sometimes disabling condition, with few effective treatments and no cure. Tinnitus is thought to involve dysfunction in central brain networks subsequent to peripheral injury or interference; thus, neurostimulation therapies that directly target central circuits are receiving growing interest. Of these, noninvasive transcranial electrical stimulation (tES) is an attractive option, due to its relative affordability, mobility, and favorable safety profile. A growing number of studies have demonstrated that tES of temporal/auditory cortex is effective at transiently reducing tinnitus symptoms, including tinnitus loudness and tinnitus distress. However, the results of previous clinical trials are variable, and a mechanistic understanding of tES and its therapeutic effects remains elusive. The main goal of this research is to lay the groundwork for improved, patient-centered approaches to noninvasive neurostimulation therapy for chronic tinnitus. To accomplish this long-term goal, this study will determine how the intrinsic activity and connectivity of auditory networks are affected during simultaneous tES-fMRI of auditory cortex, specifically in those patients who experience reduced tinnitus symptoms after 5 consecutive days of tES. Though the primary goal of the proposed research is to optimize tES for the treatment of tinnitus, these studies will also provide a wealth of information regarding tinnitus pathophysiology and the mechanisms of tES more generally, which is being investigated for the treatment of a wide variety of brain disorders and injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tES | Active Comparator |
| |
| Sham/Inactive tES | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial electrical stimulation (tES) | Device | In tES, a mild electrical current is passed between two or more electrodes placed on the volunteer's head (scalp). In this study, a mild unvarying (constant) electrical 2mA current is passed between two rubber electrodes placed on the head over auditory cortex for 20 minutes per session for 5 consecutive days. Because the electrical current direction (positive/negative) and current amplitude (2mA) does not vary or change during stimulation, this type of tES is also called transcranial "direct current" stimulation, or tDCS. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain function (functional connectivity) | Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI | baseline, interim (1 week after baseline), and post-tES (2 weeks after tES) |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus loudness ratings | Perceived loudness of tinnitus sensation will be measured using a 10-point Likert rating scale, where a rating of "1" indicates no tinnitus and a rating of "10" indicates loudest tinnitus imaginable. In this rating scale, higher ratings indicate more severe symptoms. | daily from date of randomization until 2 weeks after the the last study visit (tES session) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Imaging | Chicago | Illinois | 60611 | United States |
De-identified research data may be shared upon completion of the study with researchers according to Northwestern IRB approved protocols. Shared data will not include personally identifiable information or protected health information.
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After study completion, data will be made available upon request and upon approvals from all relevant regulatory agencies.
Approval of Institutional Review Board (and/or other relevant regulatory agencies) at all involved institutions.
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Eligible volunteers will be randomly assigned to receive either 5 consecutive days of active tES or 5 consecutive days of sham/inactive tES. This part of the study is optional. All eligible volunteers will receive active and sham/inactive tES during MRI.
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |