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MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

Primary Purpose

Tinnitus, Subjective

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Transcranial electrical stimulation (tES)

About this trial

This is an interventional basic science trial for Tinnitus, Subjective focused on measuring transcranial direct current stimulation (tDCS), functional magnetic resonance imaging (MRI)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Center for Translational Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tES

Sham/Inactive tES

Arm Description

Outcomes

Primary Outcome Measures

Changes in brain function (functional connectivity)

Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI

Secondary Outcome Measures

Tinnitus loudness ratings

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.

Full Information

NCT ID

NCT03544359

First Posted

May 7, 2018

Last Updated

February 8, 2023

Sponsor

Northwestern University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT03544359

Brief Title

MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

Official Title

Longitudinal Functional MRI Study of Transcranial Electrical Stimulation in Chronic Tinnitus

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

December 13, 2022 (Actual)

Study Completion Date

December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus, Subjective

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tES

Arm Type

Active Comparator

Arm Title

Sham/Inactive tES

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Transcranial electrical stimulation (tES)

Other Intervention Name(s)

Transcranial direct current stimulation (tDCS)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in brain function (functional connectivity)

Description

Changes in temporal coherence (functional connectivity) of local auditory-cortex activity and auditory networks measured with BOLD-fMRI

Time Frame

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

Secondary Outcome Measure Information:

Title

Tinnitus loudness ratings

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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.

Facility Information:

Facility Name

Center for Translational Imaging

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified research data may be shared upon completion of the study with researchers according to Northwestern IRB approved protocols. Shared data will not include personally identifiable information or protected health information.

IPD Sharing Time Frame

After study completion, data will be made available upon request and upon approvals from all relevant regulatory agencies.

IPD Sharing Access Criteria

Approval of Institutional Review Board (and/or other relevant regulatory agencies) at all involved institutions.

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MRI Study of Noninvasive Transcranial Electrical Stimulation in Tinnitus

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