CompletedEarly Phase 1

MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

United States20 participantsStarted 2018-08-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 pregn…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in brain function (functional connectivity)

Timeframe: baseline, interim (1 week after baseline), and post-tES (2 weeks after tES)

Trial details

NCT IDNCT03544359

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-13

View on ClinicalTrials.gov More Tinnitus, Subjective trials