MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tinnitus, Subjective
- Sponsor
- Northwestern University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes in brain functional connectivity.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Amber Leaver
Research Associate Professor
Northwestern University
Eligibility Criteria
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:
- •Present for at least one year prior to start of study
- •Present (can be heard when consciously attended to) \>50% of awake time
- •Intrudes (is heard even when attempting to ignore/mask) \>10% of awake time
- •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:
- •Meniere's disease
- •Pulsatile tinnitus
- •Acoustic neuroma
- •Spontaneous optoacoustic emissions
- •Any other known medical origin
- •Severe mood disorder (major depression or anxiety)
- •Diagnosis of any medical condition potentially affecting brain function, including:
Outcomes
Primary Outcomes
Changes in brain functional connectivity.
Time Frame: 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 Outcomes
- Changes in tinnitus symptoms(1 week, 2 weeks, 1 month)