MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

NCT ID: NCT03544359

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-12-13

Brief 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.

Detailed Description

Chronic subjective tinnitus is a common and sometimes disabling condition, with few effective treatments and no cure. Tinnitus is thought to involve dysfunction in central brain networks subsequent to peripheral injury or interference; thus, neurostimulation therapies that directly target central circuits are receiving growing interest. Of these, noninvasive transcranial electrical stimulation (tES) is an attractive option, due to its relative affordability, mobility, and favorable safety profile. A growing number of studies have demonstrated that tES of temporal/auditory cortex is effective at transiently reducing tinnitus symptoms, including tinnitus loudness and tinnitus distress. However, the results of previous clinical trials are variable, and a mechanistic understanding of tES and its therapeutic effects remains elusive. The main goal of this research is to lay the groundwork for improved, patient-centered approaches to noninvasive neurostimulation therapy for chronic tinnitus. To accomplish this long-term goal, this study will determine how the intrinsic activity and connectivity of auditory networks are affected during simultaneous tES-fMRI of auditory cortex, specifically in those patients who experience reduced tinnitus symptoms after 5 consecutive days of tES. Though the primary goal of the proposed research is to optimize tES for the treatment of tinnitus, these studies will also provide a wealth of information regarding tinnitus pathophysiology and the mechanisms of tES more generally, which is being investigated for the treatment of a wide variety of brain disorders and injuries.

Conditions

Tinnitus, Subjective

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active tES

Group Type: ACTIVE_COMPARATOR

Transcranial electrical stimulation (tES)

Intervention Type: DEVICE

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.

Sham/Inactive tES

Group Type: SHAM_COMPARATOR

Transcranial electrical stimulation (tES)

Intervention Type: DEVICE

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.

Interventions

Transcranial electrical stimulation (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.

Intervention Type: DEVICE

Other Intervention Names

Transcranial direct current stimulation (tDCS)

Eligibility Criteria

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

• 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amber Leaver

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Translational Imaging

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R21DC015880

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00207056

Identifier Type: -

Identifier Source: org_study_id