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

University of Michigan

Status: Completed

Conditions: Tinnitus

Treatments: Device: Sham SCS/Burst-SCS; Device: Burst-SCS/sham SCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03621735

HUM00143675

1RF1MH114244 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups

Sham then Active

Other group

Description:

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.

Treatment:

Device: Burst-SCS/sham SCS

Active then Sham

Other group

Description:

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.

Treatment:

Device: Sham SCS/Burst-SCS