MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active
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Device: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
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| Sham Comparator: Sham
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Device: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
|
Outcome Measures
Primary Outcome Measures
- Changes in brain functional connectivity. [immediate]
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).
Secondary Outcome Measures
- Changes in tinnitus symptoms [1 week, 2 weeks, 1 month]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages between 18 and 75
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Race/ethnicity: all races and ethnic groups
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Sex/Gender: all
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Capacity to provide informed consent
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Subjective tinnitus symptoms confirmed by patient self report meeting the following criteria:
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Present for at least one year prior to start of study
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Present (can be heard when consciously attended to) >50% of awake time
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Intrudes (is heard even when attempting to ignore/mask) >10% of awake time
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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
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Stable standard or no pharmacological treatment regimen for tinnitus with no change in treatment 6 weeks prior to study start
Exclusion Criteria:
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Ages below 18 (neurobiology is quite different in children vs. adults)
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Ages above 75 (cortical excitability changes with age)
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Tinnitus symptoms with known medial origin, including:
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Meniere's disease
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Pulsatile tinnitus
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Acoustic neuroma
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Spontaneous optoacoustic emissions
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Any other known medical origin
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Severe mood disorder (major depression or anxiety)
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Diagnosis of any medical condition potentially affecting brain function, including:
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neuropsychiatric or mental disorders (bipolar, post-traumatic stress disorder, etc.)
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severe mood disorders (major depression or anxiety)
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psychotic states or disorders
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developmental disorders
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neurological disorders, including mild cognitive impairment
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significant head injury
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significant history of alcohol/substance abuse or dependence
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active chronic pain condition (>1 year duration)
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other major medical conditions (e.g., cancer, stroke).
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MRI contraindications:
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metal or other implants that are not MR-safe
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claustrophobia
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pregnancy or suspected pregnancy
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tDCS contraindications*:
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skin conditions or injuries on the scalp
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hair extensions, wigs, braids, etc. that cannot be removed prior to the study
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metal implants or pacemakers (also contraindicated for MRI)
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Non-English speakers (due to written consent and questionnaires administered)
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Significant history of alcohol/substance abuse or dependence within last 12 months
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Neurostimulation or neuromodulation treatment longer than 20 minutes within the past 3 months
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Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, or anti-psychotics.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Translational Imaging at Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00215708