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

NCT ID: NCT05120037

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-07-31

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.

Conditions

Tinnitus, Subjective

Study Design

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

Study Groups

Active

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).

Sham

Group Type: SHAM_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amber Leaver

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Translational Imaging at Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00215708

Identifier Type: -

Identifier Source: org_study_id