 
| |
Electrical stimulation
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.
CONSENT 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:
- Avoidance therapy:
 | 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) and
marijuana 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
it's characteristics of success with few side effects.
Subjects
Inclusion Criteria
 | 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. |
|
Exclusion Criteria
| Objective tinnitus
| 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. |
| |
Procedure
| 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 meneire's syndrome. Many of these patients have improvement of ear
pressure sensation and vertigo.
Adverse Effects
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.
Rights -- 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.
|
