MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T) (MRI HDtES-T)

The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with chronic subjective tinnitus measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation

Detailed Description

This is an investigator-initiated MRI study of High Definition (HD) transcranial electrical stimulation (tES) in adults with chronic subjective tinnitus. HDtES is a mild, noninvasive form of brain stimulation using small electrodes to target a small part of the brain/cortex. Primary outcomes are changes in brain function and connectivity measured with MRI before and after a single 20-minute session of HDtES. Secondary outcomes are changes in tinnitus symptoms after 20-minutes of HDtES on 5 consecutive days.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Center for Translational Imaging at Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages between 18 and 75
2. Race/ethnicity: all races and ethnic groups
3. Sex/Gender: all
4. Capacity to provide informed consent

5. Subjective tinnitus symptoms confirmed by patient self report meeting the following criteria:

   1. Present for at least one year prior to start of study
   2. Present (can be heard when consciously attended to) >50% of awake time
   3. Intrudes (is heard even when attempting to ignore/mask) >10% of awake time
6. 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
7. Stable standard or no pharmacological treatment regimen for tinnitus with no change in treatment 6 weeks prior to study start

Exclusion Criteria:

1. Ages below 18 (neurobiology is quite different in children vs. adults)
2. Ages above 75 (cortical excitability changes with age)

3. Tinnitus symptoms with known medial origin, including:

   1. Meniere's disease
   2. Pulsatile tinnitus
   3. Acoustic neuroma
   4. Spontaneous optoacoustic emissions
   5. Any other known medical origin
4. Severe mood disorder (major depression or anxiety)

5. Diagnosis of any medical condition potentially affecting brain function, including:

   1. neuropsychiatric or mental disorders (bipolar, post-traumatic stress disorder, etc.)
   2. severe mood disorders (major depression or anxiety)
   3. psychotic states or disorders
   4. developmental disorders
   5. neurological disorders, including mild cognitive impairment
   6. significant head injury
   7. significant history of alcohol/substance abuse or dependence
   8. active chronic pain condition (>1 year duration)
   9. other major medical conditions (e.g., cancer, stroke).

6. MRI contraindications:

   1. metal or other implants that are not MR-safe
   2. claustrophobia
   3. pregnancy or suspected pregnancy

7. tDCS contraindications*:

   1. skin conditions or injuries on the scalp
   2. hair extensions, wigs, braids, etc. that cannot be removed prior to the study
   3. metal implants or pacemakers (also contraindicated for MRI)
8. Non-English speakers (due to written consent and questionnaires administered)
9. Significant history of alcohol/substance abuse or dependence within last 12 months
10. Neurostimulation or neuromodulation treatment longer than 20 minutes within the past 3 months
11. Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, or anti-psychotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Device: Transcranial Direct Current Stimulation; Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
Sham Comparator: Sham	Device: Transcranial Direct Current Stimulation; Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain functional connectivity.	Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in tinnitus symptoms	Symptoms of tinnitus will be measured before and after 5 sessions of tDCS using the Tinnitus Functional Index (TFI). Change in TFI scores will be used as a secondary outcome measure. Score range is 0-100, where low scores indicate low symptoms.	1 week, 2 weeks, 1 month

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: STU00215708

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No