Clinical trial NCT03621735: Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts
Official title: Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts- Stage 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Ringing in the ear
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Objective Tinnitus Loudness
timeFrame: Up to 24 weeks
measure: Change in Tinnitus Functional Index (TFI)
timeFrame: Up to 36 weeks
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change in Tinnitus Bandwidth/Spectrum (TinnTester Interactive Software)
timeFrame: Up to 24 weeks
measure: Changes in Minimum Masking Level (MML)
timeFrame: Up to 24 weeks
measure: Tinnitus Hearing Survey
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Susan Shore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: