To date, there have not been any serious
medical adverse events resulting from exposure to the
Resonator™ device. However, in other studies, magnetic
stimulation has been shown to increase the risk of seizures,
especially in patients with lowered seizure thresholds.
If you are at risk for seizures, you cannot participate
in any of our studies.
Also, as the exposures to the Resonator™
will take place while you are sitting on a raised platform,
there is the risk of falling. However, safety measures
have been taken to minimize this risk. There are safety
bars in place where patients get on and off the platform,
and there will be an attendant assisting as one gets on
and off the platform.
It is possible that there are other
medical risks from exposure to the Resonator™ as we do
not know all of the consequences from its use. The FDA
has not decided that the Resonator™ device or exposure
to it is “safe.” It is possible that you may suffer discomfort
or pain, but it is not likely.
Since the magnetic energy that is
produced by this device is in the Pico-Tesla range, the
magnetic energy that is delivered to the body is a fraction
of the magnetic energy produced by the earth on a constant
basis. There are no other hazards that the Company has
identified with this device.
Independent Review Consulting, Inc.’s
Institutional Review Board determined the Resonator (tm)
to be a non-significant risk (NSR) device when applied
to Parkinson's Disease and Diabetes Type 2 patients for
five independent studies, as identified below:
- Jacobson Resonator: Efficacy of
the Application of Magnetic Fields to the Treatment
of Parkinson’s Disease Pilot Study Protocol, APPLIED
MAGNETICS, LLC. Version 1.6, February 20, 2007. IRC
# 07021-02.
- Jacobson Resonator: A double-blind,
sham-stimulation controlled study of the application
of magnetic fields using the Jacobson Resonator for
the treatment of Parkinson’s Disease: phase two pilot
study protocol. Version 2.5, Oct 2007. IRC#
07102-01.
- An open label extension study for
subjects previously treated in either pilot I or pilot
II studies of the application of magnetic fields using
the Resonator (tm) for the treatment of Parkinson's
Disease: Extension pilot study protocol, Version 4.0,
March 14, 2008.
IRC# 06052-01.IRC Resonator
Device NSR#: DAM-003.
- A Controlled Pilot Study of the
Application of Magnetic Fields Using the Resonator (tm)
in Adjunctive Management of Type 2 Diabetes; Version
1.8, December 2, 2008; Pico-Tesla Magnetic Therapies,
LLC., a subsidiary of APPLIED MAGNETICS, LLC. IRC
Study#08165-01
- A Randomized, Double-Blind, Placebo-Controlled
Study of the Application of Magnetic Fields Using the
Resonator™ in Adjunctive Management of Type 2
Diabetes Mellitus, Pilot Study II.
IRC # 09109-01
