JOHN LI, M.D.
OTOLOGY NEUROTOLOGY RESOURCES
210 Jupiter Lakes Blvd #5105
Jupiter, FL 33458
Electrical stimulation is physical therapy modality that in the past has been used primarily for rehabilitation of chronic pain and musculoskeletal problems. It has recently been found that an electrical current could be applied to the external ear with actual suppression of tinnitus. Applied with a blunt tipped probe, the microvoltage current is distributed around the affected ear. The amount of current is adjusted to the patient's comfort level. Success is quite variable. Below is the consent form for our on-going electrical stimulation study project. Please print this page and sign it to be included in our protocol.
Consent form to be a tinnitus protocol study subject
Subjective idiopathic tinnitus is a phantom perception of sound not actually related to any outside source (noises only the patient, and not an outside observer, can hear). Subjective idiopathic tinnitus it very difficult to evaluate and treat. Unfortunately, it is usually caused by irreversible damage to the cells of the hearing organ. Attempts to improve tinnitus equate to attempts to revive damaged hearing cells by improving blood flow, avoiding damaging toxins and stimulation of healthy cells that are near the damaged one to block out the phantom sounds.
Standard therapy for treating subjective idiopathic tinnitus is as follows:
|Exposure to loud sounds and noises. (hearing protection )|
|Avoid drugs that affect the inner ear. Aspirin, Lasix, Nerve stimulants, coffee and colas (caffeine), tobacco (nicotine), marijuana, and Gentamycin class antibiotics (toxic to the inner ear)|
|Reduce exposure to nervous anxiety and stress.|
|Decrease your intake of salt (which impairs good blood circulation).|
Drugs and Vitamins that improve inner ear blood flow.
|Niacin, Lipoflavanoids, Ginko-Biloba Extracts|
Exercise daily. (It improves circulation.)
For subjective idiopathic tinnitus that does not respond to standard therapy, there are other alternatives - none of which generally have greater than a 50% chance of success. These alternatives include: tinnitus masking, hearing aids, biofeedback, acupuncture, antidepressant medication, transtympanic medications (needle injection through the ear drum) and electrical stimulation. We have chosen to evaluate electrical stimulation because of its characteristics of success with few side effects.
|Bothersome subjective idiopathic tinnitus symptoms > 3 months and failure of standard tinnitus treatment.|
|Age over 18 years if healthy and has cognitive ability to understand and sign consent.|
|History of radiation to the head or neck area, brain tumor, previous ear (except tubes) / brain surgery.|
|under 18 years old, in poor health, or pregnant.|
|Complete history, physical, current audiogram (within 3 months), tinnitus handicap inventory questionnaire and informed consent are obtained prior to treatment.|
|Study participants will receive periauricular (around the ear) electrical stimulation at a designated Occupational Therapy Electrical Stimulation institution. These consist of 6 sessions given over 2 weeks.|
|After the study, patients return to Dr. Li's office for a follow up examination, questionnaire and audiogram. The results are compared with the originals.|
What to expect:
Medical benefits which might reasonably be expected from participating in this study are a reduction in symptoms. Although quite variable, most patients notice a little tingling during stimulation. Some patients note subjective improvement within the first 4 sessions. Rarely does anyone notice immediate improvement. Sometimes the intensity is modified, usually decreased. Occasionally the pitch is modified. Some patients who started with constant tinnitus notice a fluctuation in intensity. Roughly 50% of the patients respond. The others notice little to no difference. We have noticed that some patients respond better than others. This seems to be the case for patients with Meniere's syndrome. Many of these patients have improvement of ear pressure sensation and vertigo.
Subjects will be asked to report any adverse effects, and these will be recorded on a data sheet. Anticipated possible adverse effects include ear "stinging" or tingling during the stimulation (none reported afterwards). Although none of the patients from our prior experience have reported any permanent worsening of the tinnitus, and less than 1% have reported temporary worsening, it remains a possibility. There may be other risks which are currently unforeseeable.
My research records will be kept confidential to the extent provided by the law. If publications result, my name will not be used and I will not be identifiable in any way. In the event that I believe participation in this research study has led to injury, I understand that I must contact Dr. Li at (561) 626-9523 to identify the medical resources which may be available to me and to assist me in obtaining appropriate medical care. I understand that my doctor, the investigators, their affiliated organizations and hospitals, and the Federal and State governments do not have any program to provide compensation for persons who may experience injury while participating in research projects.
Participation in this study is voluntary. I am free to decline to participate or to discontinue participation in the study at any time without any penalty or loss of benefits to which I may otherwise be entitled. The investigator is also free to terminate my participation in the study at any time.
I have had the opportunity to ask questions concerning the procedures to be used. If I have any further questions concerning the research conducted or any rights I may have, I may contact Dr. Li at (561) 626-9523.
If I wish to participate in this study, I should sign this form. I may receive a copy of this consent if requested.
Please print this page and sign it to be included in our protocol.
Back to Tinnitus Page
Copyright © 2013 John Li M.D. All Rights Reserved