TinnitusNCT02283216
Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
A study testing noise sound stimulation (Tucker-Davis Technologies), body electrical stimulation (Digitimer device) and transcranial magnetic stimulation (Magstim) in people with Tinnitus, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of the study is to investigate different stimulation parameters for a new noninvasive approach for modulating the brain that could potentially be beneficial for decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy (mSync). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- noise sound stimulation (Tucker-Davis Technologies), body electrical stimulation (Digitimer device) and transcranial magnetic stimulation (Magstim)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 13 Sep 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have subjective, non-pulsatile, and bothersome tinnitus
- Will not start any new tinnitus treatment during the study
- Ability to give informed consent and understand study objectives in English
- Willing and able to understand and comply with all study-related procedures
Who cannot join
- Substantial hearing loss or hyperacusis that may interfere with the study
- Medical history of other ear or brain disorders, history of seizures, or currently using any medication or treatments that can cause or increase the chances of seizures
- Any implanted medical or metal device, such as a pacemaker, aneurysm clip, or cochlear implant
- Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children need extra protection for their safety)
- Any handicap that prevents the subject from reliably performing the tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Nils Hasselmo Hall, 6-105
Minneapolis, Minnesota, 55455
About this study
The purpose of the study is to investigate different stimulation parameters for a new noninvasive approach for modulating the brain that could potentially be beneficial for decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy (mSync). mSync uses a combination of acoustic stimulation played through headphones and low levels of electrical current delivered via electrodes placed on the surface of different body regions. The timing interval between the acoustic and body stimulation is varied in order to cause different types of changes in the brain. In addition to acoustic and body stimulation, noninvasive cortical stimulation will also be presented as part of mSync to attempt to further modulate or decrease the tinnitus percept. Cortical stimulation will be performed by placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can travel through the skin and bone to create electrical current inside the head. For this study, different body locations as well as specific timing intervals among acoustic, body, and cortical stimulation will be investigated to identify appropriate parameters that can modulate and potentially decrease tinnitus perception. Different mSync parameters will be investigated across multiple testing sessions (up to 16 weekly sessions) and the tinnitus percept will be closely monitored throughout the study.
Read the detailed description
This study is not specifically seeking to treat tinnitus but is designed to investigate various mSync parameters that can alter the tinnitus percept. Findings from this study will help identify specific mSync parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.
- Conditions
- Tinnitus
- Being tested
- noise sound stimulation (Tucker-Davis Technologies), body electrical stimulation (Digitimer device), transcranial magnetic stimulation (Magstim)
- Keywords
- neuromodulation, noninvasive, plasticity, transcranial magnetic stimulation, hearing, hyperacusis
- Medical subject headings
- Tinnitus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noise sound stimulation (Tucker-Davis Technologies)Device
Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.
body electrical stimulation (Digitimer device)Device
Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device.
transcranial magnetic stimulation (Magstim)Device
Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device.
| Study group | Role | What they receive |
|---|---|---|
| Acoustic, Body, Cortical | Experimental | Acoustic corresponds to noise sound stimulation. Body corresponds to body electrical stimulation. Cortical corresponds to transcranial magnetic stimulation. Acoustic is presented together with body and cortical stimulation. Different body locations and timing among acoustic, body, and cortical stimulation are presented across testing sessions. Receives: Device: noise sound stimulation (Tucker-Davis Technologies); Device: body electrical stimulation (Digitimer device); Device: transcranial magnetic stimulation (Magstim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Functional Index Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Measured: Change from baseline score at 1 week after testing paradigm
Change in Minimal Masking Level
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
Measured: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm
Secondary outcomes (5)
Change in Tinnitus Handicap Inventory Questionnaire Score
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Measured: Change from baseline score at 1 week after testing paradigm
Change in Tinnitus Rating (0-10, 10 being worst)
The subject rates the disturbance or bothering nature of the tinnitus.
Measured: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Subjective Description
The subject describes the quality, characteristics and bothering nature of the tinnitus.
Measured: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Matching (pitch and loudness)
The subject adjusts the loudness and pitch (i.e., frequency) of a sound played to an ear to that of the tinnitus percept.
Measured: Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm
Daily Tinnitus Journal Entries
The subject describes the quality, characteristics and bothering nature of the tinnitus on a daily basis. The subject can also include any unusual or interesting events relating to the tinnitus that he/she feels would be relevant for the study.
Measured: 0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study start1 Jun 2015
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Why it stopped: Lack of funding and personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert Lim, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283216
- Sponsor's protocol ID
- 1409M53708
- Status last verified
- Apr 2019
- First submitted
- 26 Oct 2014
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
- ClinicalTrials.gov ID
- NCT02283216
- Acronym / sponsor ID
- 1409M53708
- Conditions
- Tinnitus
- Keywords
- neuromodulation, noninvasive, plasticity, transcranial magnetic stimulation, hearing, hyperacusis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding and personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 5 Nov 2014 (estimated)
- 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 the study is to investigate different stimulation parameters for a new noninvasive approach for modulating the brain that could potentially be beneficial for decreasing tinnitus perception. The new approach is called Multimodal Synchronization Therapy (mSync). mSync uses a combination of acoustic stimulation played through headphones and low levels of electrical current delivered via electrodes placed on the surface of different body regions. The timing interval between the acoustic and body stimulation is varied in order to cause different types of changes in the brain. In addition to acoustic and body stimulation, noninvasive cortical stimulation will also be presented as part of mSync to attempt to further modulate or decrease the tinnitus percept. Cortical stimulation will be performed by placing a magnetic coil over a spot on the head and sending a brief magnetic pulse that can travel through the skin and bone to create electrical current inside the head. For this study, different body locations as well as specific timing intervals among acoustic, body, and cortical stimulation will be investigated to identify appropriate parameters that can modulate and potentially decrease tinnitus perception. Different mSync parameters will be investigated across multiple testing sessions (up to 16 weekly sessions) and the tinnitus percept will be closely monitored throughout the study.
Detailed description
This study is not specifically seeking to treat tinnitus but is designed to investigate various mSync parameters that can alter the tinnitus percept. Findings from this study will help identify specific mSync parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acoustic, Body, Cortical | Experimental | Device: noise sound stimulation (Tucker-Davis Technologies), Device: body electrical stimulation (Digitimer device), Device: transcranial magnetic stimulation (Magstim)Acoustic corresponds to noise sound stimulation. Body corresponds to body electrical stimulation. Cortical corresponds to transcranial magnetic stimulation. Acoustic is presented together with body and cortical stimulation. Different body locations and timing among acoustic, body, and cortical stimulation are presented across testing sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have subjective, non-pulsatile, and bothersome tinnitus
- Will not start any new tinnitus treatment during the study
- Ability to give informed consent and understand study objectives in English
- Willing and able to understand and comply with all study-related procedures
Key exclusion criteria (5 listed)
- Substantial hearing loss or hyperacusis that may interfere with the study
- Medical history of other ear or brain disorders, history of seizures, or currently using any medication or treatments that can cause or increase the chances of seizures
- Any implanted medical or metal device, such as a pacemaker, aneurysm clip, or cochlear implant
- Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children need extra protection for their safety)
- Any handicap that prevents the subject from reliably performing the tests
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 |
|---|---|---|
| noise sound stimulation (Tucker-Davis Technologies)Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device. | Device | Acoustic, Body, Cortical |
| body electrical stimulation (Digitimer device)Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device. | Device | Acoustic, Body, Cortical |
| transcranial magnetic stimulation (Magstim)Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device. | Device | Acoustic, Body, Cortical |
Primary outcome
Change in Tinnitus Functional Index Questionnaire Score
Time frame: Change from baseline score at 1 week after testing paradigm
A series of questions to assess the quality and bothering nature of the tinnitus, which is then quantified into a single score.
Change in Minimal Masking Level
Time frame: Change in baseline level at an expected average of 1 minute and 1.5 hours after testing paradigm
A narrowband noise (from 2-12 kHz) is presented to the tinnitus ear and the minimum sound level (in decibel sound pressure level, decibel SPL) is determined that completely masks the tinnitus percept.
5 secondary outcomes
Change in Tinnitus Handicap Inventory Questionnaire Score
Time frame: Change from baseline score at 1 week after testing paradigm
Change in Tinnitus Rating (0-10, 10 being worst)
Time frame: Change in baseline rating at an expected average of 4 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Subjective Description
Time frame: Change in baseline description at an expected average of 5 minutes and 1.5 hours after testing paradigm
Change in Tinnitus Matching (pitch and loudness)
Time frame: Change in baseline pitch and loudness at an expected average of 1.5 hours after testing paradigm
Daily Tinnitus Journal Entries
Time frame: 0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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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.
Hubert Lim, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noise sound stimulation (Tucker-Davis Technologies), body electrical stimulation (Digitimer device) and transcranial magnetic stimulation (Magstim) in people with Tinnitus, run by University of Minnesota 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 May 2019. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Tinnitus Functional Index Questionnaire Score (time frame: Change from baseline score at 1 week after testing paradigm). The study lists 2 primary outcomes in all. 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 1 May 2019.