Tinnitus, SubjectiveMRI HDtES-TNCT05120037
MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
A study testing Transcranial Direct Current Stimulation in people with Tinnitus, Subjective, run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Translational Imaging at Northwestern University
Chicago, Illinois, 60611
About this study
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.
Read the 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
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation |
| Sham | Sham comparator | Not described Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: immediate
Secondary outcomes (1)
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.
Measured: 1 week, 2 weeks, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Leaver, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120037
- Sponsor's protocol ID
- STU00215708
- Acronym
- MRI HDtES-T
- Status last verified
- Jan 2023
- First submitted
- 12 Nov 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
- ClinicalTrials.gov ID
- NCT05120037
- Acronym / sponsor ID
- MRI HDtES-T / STU00215708
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Transcranial Direct Current Stimulation |
| Sham | Sham comparator | Device: Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (31 listed)
- 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:
- Severe mood disorder (major depression or anxiety)
- Diagnosis of any medical condition potentially affecting brain function, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationTranscranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions). | Device | Active, Sham |
Primary outcome
Changes in brain functional connectivity.
Time frame: 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).
1 secondary outcome
Changes in tinnitus symptoms
Time frame: 1 week, 2 weeks, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Tinnitus, Subjective, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in brain functional connectivity. (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.