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
About this trial
This is an interventional basic science trial for Tinnitus, Subjective
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.
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
NCT ID
NCT05120037
First Posted
November 12, 2021
Last Updated
January 10, 2023
Sponsor
Northwestern University
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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