MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

NCT03544359 | Completed Early Phase 1

• 2 other identifiers: STU00207056R21DC015880
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Overall activity and local connectivity within brain regions near tES electrodes, and
2. 2.Functional connectivity within brain networks associated with brain regions near tES electrodes.

Conditions

Tinnitus, Subjective

Keywords

transcranial direct current stimulation (tDCS); functional magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Changes in brain function (functional connectivity)

  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 Outcomes (1)

• Tinnitus loudness ratings

  daily from date of randomization until 2 weeks after the the last study visit (tES session)

Study Arms (2)

Active tES

ACTIVE COMPARATOR

Device: Transcranial electrical stimulation (tES)

Sham/Inactive tES

SHAM COMPARATOR

Device: Transcranial electrical stimulation (tES)

Interventions

Transcranial electrical stimulation (tES) 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.

Also known as: Transcranial direct current stimulation (tDCS)

Active tES; Sham/Inactive tES

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Center for Translational Imaging

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Eligible volunteers will be randomly assigned to receive either 5 consecutive days of active tES or 5 consecutive days of sham/inactive tES. This part of the study is optional. All eligible volunteers will receive active and sham/inactive tES during MRI.

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 1, 2018
• Study Start: August 1, 2018
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: After study completion, data will be made available upon request and upon approvals from all relevant regulatory agencies.
• Access Criteria: Approval of Institutional Review Board (and/or other relevant regulatory agencies) at all involved institutions.

Locations

US (1)