MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Tinnitus, Subjective

In brief

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: 1. Overall activity and local connectivity within brain regions near tES electrodes, and 2. Functional connectivity within brain networks associated with brain regions near tES electrodes. In exploratory analyses, we also measure the extent to which the hypothesized changes listed above a related to changes in tinnitus symptoms after tES.

Key facts

Study ID

NCT03544359

Run by

Northwestern University

People needed

20

Starts

2018-08-01

Expected to finish

2022-12-13

Last updated by the study team

2023-02-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages between 18 and 65
• Race/ethnicity: all races and ethnic groups
• Sex/Gender: all
• Capacity to provide informed consent
• Subjective tinnitus symptoms for at least one year prior (confirmed by patient self-report)
• 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 (e.g., SSRI or SNRI) with no change in treatment 6 weeks prior to study start

You may not qualify if…

• Ages below 18 (neurobiology is quite different in children vs. adults)
• Ages above 65 (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
• Diagnosis of any medical condition potentially affecting brain function, including: neuropsychiatric or mental disorders, mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence, chronic pain (>1 year duration)
• MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
• tDCS contraindications*: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI) *Please note that history of seizures or epilepsy, stroke, and brain injury are not safety concerns for tES use, and may be inclusion criteria for other tES studies. However, individuals with history of these conditions will be excluded here because these conditions are not a focus of the current study (see above).
• Non-English speakers (due to written consent and questionnaires administered)
• other major medical conditions (e.g., cancer, stroke).
• Significant history of alcohol/substance abuse or dependence within last 12 months
• Neurostimulation or neuromodulation treatment for any reason within the past 3 months
• Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants.
• Prisoners will not participate in this study.

Where it is running

• Center for Translational Imaging — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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