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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 : Enrolling by invitation
First Posted : August 8, 2018
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Susan E. Shore, University of Michigan

Tracking Information
First Submitted Date  ICMJE July 30, 2018
First Posted Date  ICMJE August 8, 2018
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • 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.
  • 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.
  • Change Residual Inhibition as measured by the TinnTester software [ Time Frame: Baseline, and up to 38 weeks ]
    Determine if residual inhibition changes in the active treatment arm
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts
Official Title  ICMJE Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts- Stage 2
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • 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, the juncture of the temporomandibular joint, 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
  • Device: Sham SCS/Burst-SCS

    Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint, 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
Study Arms  ICMJE
  • 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.

    Intervention: Device: Burst-SCS/sham SCS
  • 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.

    Intervention: Device: Sham SCS/Burst-SCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 11, 2020)
300
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
100
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03621735
Other Study ID Numbers  ICMJE HUM00143675
1RF1MH114244 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Susan E. Shore, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Susan Shore, Ph.D. University of Michigan
PRS Account University of Michigan
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP