Auditory-somatosensory Stimulation to Alleviate Tinnitus

• ClinicalTrials.gov Identifier: NCT02974543
• Recruitment Status: Completed
• First Posted: November 28, 2016
• Results First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Sponsor: University of Michigan
• Collaborator: Wallace H Coulter Center for Translational Research
• Information provided by (Responsible Party): Susan E. Shore, University of Michigan

Study Description

Brief Summary:

The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.

Condition or disease	Intervention/treatment	Phase
Tinnitus	Device: Sham Treatment: unimodal auditory stimulation; Device: Active Treatment: Bimodal auditory-somatosensory stimulation	Not Applicable

Detailed Description:

This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.

The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
• Study Start Date: September 2014
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Sham 1st (Auditory only) then Active (Bimodal); To mitigate potential placebo effects, 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: Sham Treatment: unimodal auditory stimulation; All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.; Device: Active Treatment: Bimodal auditory-somatosensory stimulation; 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.
Active (Bimodal) then Sham (Auditory only); During active treatment, the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, 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.	Device: Sham Treatment: unimodal auditory stimulation; All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.; Device: Active Treatment: Bimodal auditory-somatosensory stimulation; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline [ Time Frame: Four weeks on treatment (or sham) ]
   Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. 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 It will be administered weekly through out the study.
2. Change in Tinnitus Loudness as Assessed by TinnTester [ Time Frame: 4 weeks on treatment (or sham) ]
   Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
3. Able to modulate their tinnitus with a somatic maneuver
4. BothersomeTinnitus.

Exclusion Criteria:

• No participation in a tinnitus treatment regimen within the past four weeks
• Retrocochlear pathology/ VIIIth nerve lesion

Contacts and Locations

Locations

United States, Michigan

University of Michigan Kresge Hearing Research Institute

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Wallace H Coulter Center for Translational Research

Investigators

• Principal Investigator: Susan Shore, Ph.D; University of Michigan

More Information

• 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: NCT02974543
• Other Study ID Numbers: HUM00088432
• First Posted: November 28, 2016
• Results First Posted: May 17, 2017
• Last Update Posted: May 17, 2017
• Last Verified: April 2017

Keywords provided by Susan E. Shore, University of Michigan:

tinnitus

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases