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

Primary Purpose

Tinnitus, Subjective

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Translational Imaging at Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active

Sham

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
November 12, 2021
Last Updated
January 10, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05120037
Brief Title
MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
Acronym
MRI HDtES-T
Official Title
MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
Primary Outcome Measure Information:
Title
Changes in brain functional connectivity.
Description
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).
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Changes in tinnitus symptoms
Description
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.
Time Frame
1 week, 2 weeks, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages between 18 and 75 Race/ethnicity: all races and ethnic groups Sex/Gender: all Capacity to provide informed consent Subjective tinnitus symptoms confirmed by patient self report meeting the following criteria: Present for at least one year prior to start of study Present (can be heard when consciously attended to) >50% of awake time Intrudes (is heard even when attempting to ignore/mask) >10% of awake time 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 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 75 (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 Severe mood disorder (major depression or anxiety) Diagnosis of any medical condition potentially affecting brain function, including: neuropsychiatric or mental disorders (bipolar, post-traumatic stress disorder, etc.) severe mood disorders (major depression or anxiety) psychotic states or disorders developmental disorders neurological disorders, including mild cognitive impairment significant head injury significant history of alcohol/substance abuse or dependence active chronic pain condition (>1 year duration) other major medical conditions (e.g., cancer, stroke). 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) Non-English speakers (due to written consent and questionnaires administered) Significant history of alcohol/substance abuse or dependence within last 12 months Neurostimulation or neuromodulation treatment longer than 20 minutes within the past 3 months Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, or anti-psychotics.
Facility Information:
Facility Name
Center for Translational Imaging at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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

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