Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/14/2018 |
| Start Date: | November 1, 2018 |
| End Date: | January 2023 |
Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts- Stage 2
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 bothersome and constant subjective tinnitus with no greater than a mild hearing loss and
the ability to control ringing in the ears by doing something with your body or head.
Subjects will be given both the treatment and sham arms (this study will randomly assign
which treatment will be first) and have a washout period in between the two treatment groups
that could be as many as 10 weeks. The study will take approximately 32 weeks for study
subjects and the study will enroll approximately 100 individuals.
quality of life for those that are affected by tinnitus. This study will enroll subjects who
have bothersome and constant subjective tinnitus with no greater than a mild hearing loss and
the ability to control ringing in the ears by doing something with your body or head.
Subjects will be given both the treatment and sham arms (this study will randomly assign
which treatment will be first) and have a washout period in between the two treatment groups
that could be as many as 10 weeks. The study will take approximately 32 weeks for study
subjects and the study will enroll approximately 100 individuals.
Inclusion Criteria:
- Must report constant, subjective, preferably unilateral tinnitus without any active
external or middle ear pathology.
- No greater than a moderate hearing loss at the tinnitus frequencies (≤55 Decibels
Hearing Level).
- 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)
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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