- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544359
MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus
Longitudinal Functional MRI Study of Transcranial Electrical Stimulation in Chronic Tinnitus
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:
- Overall activity and local connectivity within brain regions near tES electrodes, and
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Center for Translational Imaging
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active tES
|
In tES, a mild electrical current is passed between two or more electrodes placed on the volunteer's head (scalp).
In this study, a mild unvarying (constant) electrical 2mA current is passed between two rubber electrodes placed on the head over auditory cortex for 20 minutes per session for 5 consecutive days.
Because the electrical current direction (positive/negative) and current amplitude (2mA) does not vary or change during stimulation, this type of tES is also called transcranial "direct current" stimulation, or tDCS.
Other Names:
|
SHAM_COMPARATOR: Sham/Inactive tES
|
In tES, a mild electrical current is passed between two or more electrodes placed on the volunteer's head (scalp).
In this study, a mild unvarying (constant) electrical 2mA current is passed between two rubber electrodes placed on the head over auditory cortex for 20 minutes per session for 5 consecutive days.
Because the electrical current direction (positive/negative) and current amplitude (2mA) does not vary or change during stimulation, this type of tES is also called transcranial "direct current" stimulation, or tDCS.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in brain function (functional connectivity)
Time Frame: baseline, interim (1 week after baseline), and post-tES (2 weeks after tES)
|
Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI
|
baseline, interim (1 week after baseline), and post-tES (2 weeks after tES)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus loudness ratings
Time Frame: daily from date of randomization until 2 weeks after the the last study visit (tES session)
|
Perceived loudness of tinnitus sensation will be measured using a 10-point Likert rating scale, where a rating of "1" indicates no tinnitus and a rating of "10" indicates loudest tinnitus imaginable.
In this rating scale, higher ratings indicate more severe symptoms.
|
daily from date of randomization until 2 weeks after the the last study visit (tES session)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00207056
- R21DC015880 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tinnitus, Subjective
-
State University of New York at BuffaloUniversity at BuffaloCompletedTinnitus, Subjective | Tinnitus | Noise Induced Tinnitus | Tinnitus, Objective | Tinnitus Aggravated | Tinnitus, Pulsatile | Tinnitus, Spontaneous Oto-Acoustic Emission | Tinnitus, Clicking | Tinnitus, Tensor Tympani InducedUnited States
-
Philipps University Marburg Medical CenterLinkoeping University; Eriksholm Research Centre; University Hospital of Gießen...CompletedTinnitus | Subjective Tinnitus | Chronic TinnitusGermany
-
Cairo UniversityRecruiting
-
University of ZurichRecruitingTinnitus, Subjective | TinnitusSwitzerland
-
Eye & ENT Hospital of Fudan UniversityNot yet recruiting
-
University of Illinois at Urbana-ChampaignGN Hearing A/SActive, not recruitingTinnitus, SubjectiveUnited States
-
University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland
-
Universiteit AntwerpenUniversity Hospital, AntwerpWithdrawnTinnitus, SubjectiveBelgium
-
Washington University School of MedicineNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed
-
Merz Pharmaceuticals GmbHTerminatedSubjective TinnitusUnited States, United Kingdom, Poland, Austria, Belgium, Brazil, Czech Republic, France, Germany, Mexico, Netherlands, Portugal, South Africa, Spain
Clinical Trials on Transcranial electrical stimulation (tES)
-
Seoul National University HospitalNot yet recruitingDepressive Disorder | Depression | Otorhinolaryngologic Diseases | Hearing Disorders | Tinnitus
-
University of FloridaFacial Pain Research FoundationCompleted
-
Northwestern UniversityBrain & Behavior Research FoundationCompleted
-
University of Alabama at BirminghamCompleted
-
University of British ColumbiaVancouver Coastal Health Research InstituteCompletedOrthostatic Hypotension | Postural HypotensionCanada
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Chinese University of Hong Kong; University of Waterloo and other collaboratorsRecruiting
-
Brain Electrophysiology Laboratory CompanyUnknown
-
University of MinnesotaRecruiting
-
Hebrew SeniorLifeBrain & Behavior Research FoundationRecruitingDepressive Disorder | Nervous System Diseases | Dementia | Alzheimer Disease | Major Depressive Disorder | Memory DisordersUnited States
-
VA Office of Research and DevelopmentAtlanta VA Medical Center; Providence VA Medical CenterRecruitingDepression | Depressive Disorder, Treatment-Resistant | COVID StressUnited States