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Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

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ClinicalTrials.gov Identifier: NCT03621735
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : August 11, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan E. Shore, University of Michigan

Study Description
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Brief Summary:
The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss in the tinnitus frequencies. Subjects must also have the ability to alter the loudness or pitch of the ringing in their ears by performing a head, neck, face, or upper body movement. Subjects will be given both the treatment and sham arms (the study will randomly assign which arm is administered first) and will have a washout period of 6 weeks after each arm. The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Burst-SCS/sham SCS Device: Sham SCS/Burst-SCS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts- Stage 2
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : July 6, 2022
Actual Study Completion Date : July 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Sham then Active

Active: Bimodal auditory-somatosensory stimulation

Sham: Sham Bimodal auditory-somatosensory stimulation

Subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

 Device: Burst-SCS/sham SCS

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks.

Other Name: St. Jude Medical Invisible Trial System
Active then Sham

Active: Bimodal auditory-somatosensory stimulation

Sham: Sham Bimodal auditory-somatosensory stimulation

Subjects receive both an active treatment and a sham treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

 Device: Sham SCS/Burst-SCS

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

For each arm of the study subjects will have daily treatments for 30-60 minutes for 6 weeks.

Other Name: St. Jude Medical Invisible Trial System


Outcome Measures
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Primary Outcome Measures :
  1. Change in Objective Tinnitus Loudness [ Time Frame: Baseline, and up to 38 weeks ]
    Change in Tinnitus by the TinnTester software. Participants are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). These will be collected weekly during each treatment arm and washout. Absolute differences are averaged relative to baseline to determine loudness.

  2. Change in Tinnitus Functional Index (TFI) [ Time Frame: Baseline, and up to 38 weeks ]
    TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact.These will be collected weekly during each treatment arm and washout.

  3. Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, and up to 38 weeks ]
    A 25 item questionnaire which assesses subjective impacts of tinnitus related to quality of life on a 100 point numeric scale. Scores 17 points or higher are considered bothersome tinnitus. The higher scores reflecting greater self-perceived tinnitus handicap. These will be collected weekly during each treatment arm and washout.


Secondary Outcome Measures :
  1. Change in Tinnitus bandwidth/spectrum (TinnTester Interactive Software) [ Time Frame: Baseline, and up to 38 weeks ]
    Near its start the TinnTester software asks subjects to indicate which of three sounds best resembles their tinnitus; 5 kHz pure tone ("tonal" tinnitus), a narrow band noise centered at 5 kHz (±5% of CF, BPN5 masker, "ringing" tinnitus), or a wider band of noise centered at 5 kHz (±15% of CF, BPN15 masker, "hissing" tinnitus). We will relate treatment outcomes to tinnitus bandwidth by these measurements. We will also be able to determine whether the treatment alters bandwidth.

  2. Minimum masking level (MML) [ Time Frame: Baseline, and up to 38 weeks ]
    Determine if the MML for a 5kHz tone is reduced in the active treatment arm.

  3. Tinnitus Hearing Survey [ Time Frame: Baseline, and up to 38 weeks ]
    This is a 10 question survey with a scale from 0 to 4 to determine if active treatment has an effect or interaction with perceived handicap due to hearing loss and sound level tolerance. Categories are comprised of tinnitus, hearing, and sound tolerance. An answer of 0 is no/not a problem up to 4 that is yes/a very big problem.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must report constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
  • No greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss at the tinnitus frequencies.
  • Must be able to modulate their tinnitus with a somatic maneuver
  • Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome.
  • Absence of retrocochlear pathology/8th nerve lesion
  • No participation in a tinnitus treatment regimen within the past six months or participation in the University of Michigan stage 1 clinical trial.

Exclusion Criteria:

  • Diagnosis of Meniere's disease
  • Diagnosis of Semicircular Canal Dehiscence
  • Unilateral or bilateral cochlear implant recipients
  • Diagnosis of acoustic neuroma
  • Evidence of retrocochlear disease
  • Certain medications and conditions (will be reviewed at screening)
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03621735


Locations
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United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Susan Shore, Ph.D. University of Michigan
  Study Documents (Full-Text)

Documents provided by Susan E. Shore, University of Michigan:
Informed Consent Form  [PDF] February 24, 2022

More Information
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Responsible Party: Susan E. Shore, Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03621735    
Other Study ID Numbers: HUM00143675
1RF1MH114244 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Susan E. Shore, University of Michigan:
Tinnitus
Ringing in the ear
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases