Auditory-somatosensory Stimulation to Alleviate Tinnitus

University of Michigan

Status: Completed

Conditions: Tinnitus

Treatments: Device: Sham Treatment: unimodal auditory stimulation; Device: Active Treatment: Bimodal auditory-somatosensory stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02974543

HUM00088432

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups

Sham 1st (Auditory only) then Active (Bimodal)

Other group

Description:

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.

Treatment:

Device: Sham Treatment: unimodal auditory stimulation

Device: Active Treatment: Bimodal auditory-somatosensory stimulation

Active (Bimodal) then Sham (Auditory only)

Other group

Description:

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.

Treatment:

Device: Sham Treatment: unimodal auditory stimulation

Device: Active Treatment: Bimodal auditory-somatosensory stimulation