Transcutaneous Low Frequency Therapies

1. Transcutaneous Low Frequency Therapies Studies and findings of transcutaneous low frequency therapies to address intractable conditions James D. Honeycutt, PhD AzNMA Spring 2012 CME Conference The Science and Practical Application of Bio-Energetic Medicine

2. TLFT Topics • What it is and isn’t • Brief History of the technology • Background of James Honeycutt • Studies for three types of devices • Conclusions • What’s next?

3. What is Transcutaneous Low Frequency Therapy (TLFT)? • Audible range frequencies applied directly to the skin using electrical contacts • FDA categorized as TENS1 • Requires prescribing physician • Proposed rules reduce regulations • Unique frequencies that resonate with specific tissues or organisms2 • Multiple frequency lists published and online

4. What TLFT Isn’t • It’s not a panacea • It’s not understood • It’s not electroshock therapy • It’s not new, but it’s also not mature

5. A Short History of Energy Medicine • ~1780 – Galvani discovers dissected frog legs contract with electrical current3 • Proposed all cells contain electric potential • 1880’s – X-Rays discovered from HV discharge • used for medical imaging in 18954 • Tesla proposed safety standards in 18985 • Early 1900’s – ElectroMedical Frequency Therapy begins • Royal Rife uses Tesla neon tube with RF to kill pathogens • Declared “unscientific” in 1910 Flexner report6 • Frequency Lists Accumulate from Testing7 • Commonly called “Rife Frequencies” • Most have nothing to do with Rife’s original 14 frequencies • Frequencies that “Heal” versus ones that “Kill”

6. Bio-Energetic Medicine Continues • 1950’s – NMRI invented8 • made practical in 1970’s • Captures reflected energy of resonated atoms (typ. hydrogen) • 1972 – TENS used for Pain Management9 • Electro Muscle Stimulators for muscle building • 1976 – SCENAR developed in Russia10 • A ‘Smart’ handheld TENS Cleared by FDA in 200911 • 1983 – R.O. Becker M.D.12 • Regenerates amputated appendages of frog and mice

7. Bio-Energetic Medicine Continues • 1989 Dr. Nordenström presents BCEC to US and China13 • AMA Rejects his proposals • China implements EChT for cancer treatment • 1997 – MET used for pain and more • 1/100th the current of a TENS • Multiple Precise Frequencies • 2000 – Shortwave Diathermy for other than therapeutic heating of tissues • ActiPatch and ActiBand devices use RF energy14

8. Quotable Quotes • “Concerning matter, we have been all wrong. What we have called matter is energy, whose vibration has been so lowered as to be perceptible to the senses. There is no matter.” Albert Einstein • "All matter originates and exists only by virtue of a force which brings the particle of an atom to vibration and holds this most minute solar system of the atom together. We must assume behind this force the existence of a conscious and intelligent mind. This mind is the matrix of all matter." Max Planck • "If you want to find the secrets of the universe, think in terms of energy, frequency and vibration." Nikola Tesla

9. James D. Honeycutt, PhD Bio Technology • Son of an Electrical Engineer at NV Test Site • Chemistry, Electronics, Microbiology, Biology • Started as an Electrical Engineer in 1978 • Switched to from hardware to software in 1980 • Homeopathy practiced since 1990 • Cancer Survivor 1994 and 1998 • Prompted study of Bio Technology • Wife passed from breast cancer in 2003 • Recognized need for simple wellness solutions

10. Bio-Energetics, impetus for change • Medical industry is changing as have other industries • Examples of the changes in telecomm and consumer electronics • Cost • Complexity • Regulations • Awareness

11. Moore’s Law and More • Integrated Circuits double in complexity every two years15 • Initial highly restrictive regulations are reduced or removed16 • Consumer awareness grows with demand17

12. Concerns about the Changes • Reduced consumer confidence in Allopathic medicine • Constantly rising costs, fewer insured18 • Pharmaceuticals marketed directly to patients19 • Physicians only diagnose and prescribe based upon patients’ decisions • Don’t trust legislators • Increased Iatrogenic deaths20

13. More Concerns • Consumer Overconfidence in Bio-Energetic Medicine • Weekend engineers build their own device • Compared to diagnosing and repairing a car • Cannot replace qualified physicians • Need to know what these technologies are • Need to collaborate, not litigate, with pioneers • What qualifies a prescribing physician

14. 3 TLFT Device Types • SCENAR21 • Russian designed handheld instrument • FDA Cleared for import and resale • MET (Microcurrent Electro-Therapy)22 • Console device with external leads • FDA Cleared as TENS • NuStim23 • Investigatory instrument, not marketed

15. FDA considers these TENS24 • Any device delivering electrical current • Category II, Special Controls • No category for picoTesla (pT) low frequency devices25 • FDA grants/revokes clearance based on submissions and complaints • New devices based on predicates are more easily cleared • FDA clearance is only to market as a medical device

16. FDA regulations for this category of TENS devices • April 2010 FDA Draft Guidance for TENS • Created Limited Output category26 • No Prescription for Aesthetic devices27 • Faster time to market • April 2011 FDA Draft Guidance for Lasers • No Prescription for Aesthetic devices28 • Faster time to market

17. To Prescribe or Not to Prescribe • All TENS devices currently require a prescription to be sold in the US • Could change with April 2010 proposals • What do you need to know to prescribe?

18. Basic Electricity for Healing29 • Current must flow between two points • Electrons flow from Cathode (-) to Anode (+) • Fluid based biological systems conduct current • Molecular ions (calcium, sodium, chlorides) carry current, cause electrolysis • Certain types of electrical stimulation form neurotransmitters

19. Waves • Sinusoidal is basic waveform in fluids30 • Square wave has infinite harmonics • Body ‘sees’ the triangular as square31 • Sawtooth ramps up and then off

20. Frequency and Pulses32 • Frequency is expressed in repetitions per second, or cycles per second, Hertz (Hz) • Period is expressed in Thousandths (milli) or Millionths (micro or μ) of seconds • 1 KHz = 1,000 cycles/sec. = 1 millisecond • Pulses are packets of waves with ‘off’ time

21. Mono-Polar and Bi-Polar33 • Early devices simply pulsed the current on and off • Electrons or ions only flow in one direction • Living tissues can become polarized • Polarity stress can cause irreversible damage • Can cause conflicts in neural tissues/signals • Newer devices switch directions of current • Does not add electrons to the body • Simply moves them back and forth

22. Accuracy of Frequencies • Resistor/Capacitor oscillators are ± 1% accurate • 10 Hz could be from 9.90 Hz to 10.10 Hz • Ceramic resonators are ± 0.5% accurate • 10 Hz could be from 9.95 Hz to 10.05 Hz • Cut Quartz Crystal controlled oscillators • 20 to 50 ppm (99.998% to 99.995%) • 10 Hz could be from 9.99995 to 10.00005 Hz • Quartz crystals used in esoteric healing

23. Dividing from a Frequency • All frequencies are generated by dividing from a Fundamental Frequency • Microprocessors divide by whole numbers • The higher the Fundamental, the greater the granularity of resulting frequencies • Higher frequencies require more power • Reduces battery life • Using a ‘Natural’ fundamental frequency34 • Fibonacci numbers occur throughout nature

24. Disrupt or Restore the SCN • The suprachiasmatic nuclei (SCN) 35 • Small region on the brain's midline • Controls circadian rhythms • Regulates many different body functions • Dr. Franz Halberg coined “Circadian” in 50’s36 • Transcription is not a continuous process • Occurs at beginning of ultradian rhythms • Identified strong EM could reset our rhythms • Conversely, EM could help regulate our rhythms

25. Studies and finding for SCENAR37 • Handheld • Direct Contact to Pt. • Battery powered • Variable Hz, wave, power • FDA cleared as TENS • Used Worldwide • Bio-Feedback (retrains)

26. SCENAR Analgesia for Sensory Restoration38 • 16 Men, 18 Women, mean age 55.3 yrs • All with malignancy caused pain syndrome • WHO recommended analgesics failed to revert pain • Scenar initially used to restore sensory responses • Pts received from 10 to 15 treatments • Incidentally noted analgesic benefits • 23 Pts had PR of 3-4, 8 Pts had PR of 2 • 2 Pts had 0 to 1 Pain Response improvement • Scale of 0 to 4 Pain response improvement

27. SCENAR for Burn Treatment39 • Age 44 • Third degree burns of both arms • Swelling, inflammation, limited RoM, pain • Treatment started 4th day after trauma • Twice daily for first 3 days to general zones • Used 351 Hz and low intensity SW regimen • Pain reduced immediately • Increased to every two hours by third day • Next 4 days treatment was once a day • Healed successfully with no appreciable scarring • Comparable to shortwave diathermy39A

28. SCENAR for Paralysis Rehab40 • 12 Spinal Cord Injury and 2 Head Injury Pts • All Pts present with varying degrees of paralysis or paresis • Methodology involved adding SCENAR to daily exercise and passive workouts as appropriate for each Pt for 2 to 45 weeks • All participants realized some improvements beyond those from exercise alone • Improvements noted regardless of time since injury

29. Studies and findings for MET41 • FDA Cleared as TENS • Uses 1/100th the current • Two simultaneous Hz • Applied through graphite gloves or other means (dampened)

30. MET – Cytokine changes for fibromyalgia42 • 54 Patients meeting ACR diagnostic criteria for fibromyalgia following cervical pain trauma – mean age 44 years (10-75) • 10 Point VAS used for assessing efficacy • Starting average VAS score was 7.3 ± 1.2 • VAS score average dropped to 1.3 ± 1.1 after first treatment • Treatment applied μAmp current between Pt’s feet and neck • Used 10 Hz and 40 Hz combination frequencies • Other combinations tried but were less or ineffective

31. MET for Fibromyalgia - Cont. • 5 Patients could not tolerate therapy and withdrew • 13 Patients discontinued for unrelated reasons • Experienced 83% reduction in pain from partial • Pts provided personal unit for use at home • Remaining Pts were treated from 3 to 17 weeks • Interleukin-1 and 6 levels measured • Blood samples in 6 random Pts showed reduced levels

32. MET for Delayed Onset Muscle Soreness43 • 18 Males & 17 Females, mean age 32 ± 4.2 years • All were healthy, approved for exercise • 15 minute treadmill warm-up • 5 sets of 15 maximal vol. eccentric contractions • MET was applied to one leg and not the other for 20 minutes afterwards • Soreness measured at 24, 48 and 72 hours • Using VAS 1-10 scale MET reduced soreness • 1.3 v. 5.2 @ 24hrs; 1.2 v. 7.0 @48hrs; 0.7 v. 4.0 @72hrs

33. MET for Shingles44 • 85 Year old male • Presents with rash on frontal portion of bald scalp with pain as 7 out of 10 on VAS • Initial diagnosis was incorrect actinic keratosis • Used 49 Hz and 355 Hz with no improvements • Pt returned with shingles diagnosis • Used 230 Hz and 430 Hz for two treatments, • Symptoms resolved, Pt refused further treatments • Applied this therapy for other Shingles Pts successfully

34. Studies and findings for NuStim45 • Investigatory device • Over 100 Patients • Massage Practitioner • Current flowed thru practitioner to patient • Used 40Hz & odd multiples as muscle resonant frequencies • Mixed with 10KHz PWM • Patient could ‘feel’ it

35. NuStim Considerations • NuStim Therapy used whenever massage therapy is indicate • In severe injuries or surgery, when cleared by physician for Physical Therapy (PT) • Contraindicated for implanted medical devices, deep vein thrombosis and pregnancy • No application to rashes, broken skin, cancerous areas

36. NuStim for Muscle Pain & Soreness46 • 50+ Pts, ranging from 16 to 90 years old • Seen over the course of one year • NuStim was added to traditional sports massage • Pts presented with typical muscle injuries and soreness • Applied 440 and 840 Hz with 10 KHz PWM • Used higher Hz as occasion required • 90% of Pts reported complete recovery in 90 minutes of NuStim therapy

37. NuStim in Post Orthopedic Surgery47 • 82 Year old female with full left shoulder replacement surgery • Suffered break of the humorous at surgical neck • Started NuStim 2 weeks post-op, prior to PT • Treated twice weekly for 6 weeks • Used massage techniques to apply energies • 440, 840, 1640, & 2040 Hz with 10KHz PWM • Fully recovered at 2 months post-op (½time)

38. NuStim in Reducing Muscle Scarring48 • 56 year old female injured in car accident 25 years previously • Left beast and shoulder practically detached • Presents with constant pain and severely limited range of motion (RoM) due to muscle scarring • Pt treated over 5 sessions at 2 Hrs each • Used 440, 840, 2040 and 4440 Hz • Pt now reports no pain and complete RoM

39. NuStim in Stroke Recovery49 • 55 year old female with pontine cavernoma hemorrhage • Presents with right hemiparesis and internuclear opthalmoplegia • Pt seen Quarterly due to distance • 4 consecutive days for 2-3 hours each day • 440 Hz caused muscle spasms, used others Hz • Combination of PT and MT with NuStim • After 5 sessions PT reports being 80% recovered • Pt was able to discontinue use of Bioness for walking

40. Studies Conclusion • 90% of studies are still anecdotal in nature • Double-Blind controls are needed • Placebo effects are still part of the cure • Peer reviewable reports in respectable journals • Standardization around the world • Safety protocols needed

41. Allopathic Model Still Holds • How can a device with no side-effects or risks be effective? • Risks for burns, shocks, damage to implants, neural damage, soft tissue damage, genetic damage? • If Specific Frequencies have a + effect, are there frequencies with a – effect? • YES!

42. What still needs to be done • Engineers & Physicians to work together • Establish Peer reviewable trials and studies • Both engineers and physicians need to be cross-trained in the other’s disciplines • Engineers need physiology and anatomy • Physicians need engineering and technology • Need physicians to collaborate with IRBs and manufacturers • Keep up with changes in medical industry

43. For More Information • James D. Honeycutt, Ph D • Email: james@nutesla.com • Phone: 1+(910)NuTesla (910.688.3752) • Website: http://NuTesla.com