Feasibility of auditory cortical stimulation for the treatment of tinnitus.
OBJECTIVE
To investigate the feasibility and safety of an implantable epidural cortical stimulator for the treatment of severe tinnitus.


METHODS
Prospective, controlled, single-blinded study of cortical stimulation for 4 weeks, and then an open-label stimulation period.


METHODS
Tertiary care referral center.


METHODS
Adults (n = 8) with constant tinnitus of at least 1 year with a tinnitus reaction questionnaire score greater than 33. Tinnitus was predominantly unilateral with a frequency less than 8,000 Hz.


METHODS
Surgical implantation of an investigational epidural electrode over the posterior superior temporal gyrus using functional magnetic resonance imaging targeting. A 2-week stimulation period alternated with a 2-week sham period in random order to which subjects were blinded. This was followed by continuous stimulation with parameter adjustments to maximize tinnitus suppression.


METHODS
Subjective rating of tinnitus severity, loudness, and device efficacy. Objective measures of hearing thresholds, tinnitus frequency, loudness, and minimum masking levels. Outcome measures using the Tinnitus Handicap Questionnaire, Tinnitus Reaction Questionnaire, and Beck Depression Inventory.


RESULTS
There were no effects of stimulation during the 4-week blinded period. With continuous chronic stimulation, 2 patients had persistent reduction of pure-tone tinnitus, and 6 patients had short periods of total tinnitus suppression. Significant improvements in the Beck Depression Inventory and tinnitus questionnaires were found, although objective measures of tinnitus loudness remained fairly stable. No surgical or stimulation-related complications were noted.


CONCLUSIONS
Chronic electrical stimulation of the secondary auditory cortex seems safe and warrants further investigation as a potential therapeutic intervention for the suppression of tinnitus.
Friedland
David R
DR
Department of Otolaryngology & Communication Sciences, Medical College of Wisconsin and Clement J Zablocki VA Medical Center, Milwaukee, Wisconsin 53226, USA. dfriedla@mcw.edu
Gaggl
Wolfgang
W
Runge-Samuelson
Christina
C
Ulmer
John L
JL
Kopell
Brian Harris
BH
D000328:Adult; D000368:Aged; D001299:Audiometry; D001301:Audiometry, Pure-Tone; D001303:Auditory Cortex / Q000502:physiology*; D001309:Auditory Threshold; D018592:Cross-Over Studies; D003863:Depression / Q000209:etiology / Q000523:psychology; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000009:adverse effects; D004567:Electrodes, Implanted; D004824:Epidural Space; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D013506:Otologic Surgical Procedures; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011795:Surveys and Questionnaires; D014012:Tinnitus / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome