Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus
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ClinicalTrials.gov Identifier: NCT02283216 |
Recruitment Status :
Withdrawn
(Lack of funding and personnel)
First Posted : November 5, 2014
Last Update Posted : May 1, 2019
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Condition or disease | Intervention/treatment | Phase |
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Tinnitus | Device: noise sound stimulation (Tucker-Davis Technologies) Device: body electrical stimulation (Digitimer device) Device: transcranial magnetic stimulation (Magstim) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Acoustic Stimulation Paired With Body and Cortical Stimulation for Modulating Tinnitus |
Actual Study Start Date : | June 1, 2015 |
Actual Primary Completion Date : | September 13, 2017 |
Actual Study Completion Date : | September 13, 2017 |
Arm | Intervention/treatment |
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Experimental: Acoustic, Body, Cortical
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.
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Device: 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: 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: 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. |
- 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.
- Change in Tinnitus Handicap Inventory 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 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 ]The subject rates the disturbance or bothering nature of the tinnitus.
- 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 ]The subject describes the quality, characteristics and bothering nature of the tinnitus.
- 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 ]The subject adjusts the loudness and pitch (i.e., frequency) of a sound played to an ear to that of the tinnitus percept.
- Daily Tinnitus Journal Entries [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7 days post-testing paradigm ]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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283216
United States, Minnesota | |
Nils Hasselmo Hall, 6-105 | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Hubert Lim, PhD | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT02283216 |
Other Study ID Numbers: |
1409M53708 |
First Posted: | November 5, 2014 Key Record Dates |
Last Update Posted: | May 1, 2019 |
Last Verified: | April 2019 |
neuromodulation noninvasive plasticity |
transcranial magnetic stimulation hearing hyperacusis |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |