Somatosensory Stimulation to Alleviate Tinnitus

Tinnitus Clinical Trial

Official title:

Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974543
• Other study ID #: HUM00088432
• Status: Completed
• Phase: N/A
• First received: November 14, 2016
• Last updated: November 22, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study enrolls 20 adult subjects. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Kresge Hearing Research Institute	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Wallace H Coulter Center for Translational Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TFI (Tinnitus Functional Index) after treatment or sham compared to baseline	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. Is 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.	Four weeks on treatment (or sham)	No
Primary	Change in Tinnitus loudness as assessed by TinnTester	Change in Tinnitus loudness score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that performs a loudness matching task. (TinnTester)	4 weeks on treatment (or sham)	No
Secondary	Shift in Mean Peak of Tinnitus Spectrum measured by TinnTester	Change in mean peak of tinnitus spectrum over 4 weeks from baseline for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software (TinnTester) that performs a spectral matching task.	4 weeks of treatment or sham	No
Secondary	Mean Change in Tolerance of Loud Sounds		From beginning to end of each treatment period (4 weeks)	No