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The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic subjective tinnitus measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.
This is an investigator-initiated MRI study of High Definition (HD) transcranial electrical stimulation (tES) in adults with chronic subjective tinnitus. HDtES is a mild, noninvasive form of brain stimulation using small electrodes to target a small part of the brain/cortex. Primary outcomes are changes in brain function and connectivity measured with MRI before and after a single 20-minute session of HDtES. Secondary outcomes are changes in tinnitus symptoms after 20-minutes of HDtES on 5 consecutive days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain functional connectivity. | Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z). | immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in tinnitus symptoms | Symptoms of tinnitus will be measured before and after 5 sessions of tDCS using the Tinnitus Functional Index (TFI). Change in TFI scores will be used as a secondary outcome measure. Score range is 0-100, where low scores indicate low symptoms. | 1 week, 2 weeks, 1 month |
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Inclusion Criteria:
Ages between 18 and 75
Race/ethnicity: all races and ethnic groups
Sex/Gender: all
Capacity to provide informed consent
Subjective tinnitus symptoms confirmed by patient self report meeting the following criteria:
Has discussed tinnitus symptoms with clinician (i.e., physician, audiologist) to confirm low/no likelihood of physical or neurological origin of tinnitus symptoms (e.g., acoustic neuroma, Meniere's Disease, etc.), confirmed by patient self-report
Stable standard or no pharmacological treatment regimen for tinnitus with no change in treatment 6 weeks prior to study start
Exclusion Criteria:
Ages below 18 (neurobiology is quite different in children vs. adults)
Ages above 75 (cortical excitability changes with age)
Tinnitus symptoms with known medial origin, including:
Severe mood disorder (major depression or anxiety)
Diagnosis of any medical condition potentially affecting brain function, including:
MRI contraindications:
tDCS contraindications*:
Non-English speakers (due to written consent and questionnaires administered)
Significant history of alcohol/substance abuse or dependence within last 12 months
Neurostimulation or neuromodulation treatment longer than 20 minutes within the past 3 months
Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, or anti-psychotics.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Imaging at Northwestern University | Chicago | Illinois | 60611 | United States |
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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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| 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 |