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

Not Applicable

Completed

• Conditions: Tinnitus, Subjective
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT05120037
• Lead Sponsor: Northwestern University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-15
• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Transcranial Direct Current Stimulation	-
Sham	Transcranial Direct Current Stimulation	-

Primary Outcome Measures

Name	Time	Method
Changes in brain functional connectivity.	immediate	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).

Secondary Outcome Measures

Name	Time	Method
Changes in tinnitus symptoms	1 week, 2 weeks, 1 month	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.

Trial Locations

Locations (1)

Center for Translational Imaging at Northwestern University; 🇺🇸 Chicago, Illinois, United States