Scientific Aspects

BASIC CONCEPT OF SRAMBLER THERAPYIN THE DEVELOPMENT OF SCRAMBLER THERAPY ARTIFICIAL NEURONS WERE DEVELOPED TO TRANSMIT VIA SURFACE ELECTRODES SYNTHETIC “NON-PAIN” INFORMATION TO THE CNS WHICH WOULD BE RECOGNIZABLE AS “SELF” AND “N0N-PAIN”. THIS REQUIRES THE SUBSTITUTION OF ENDOGENOUS PAIN INFORMATION WITH SYNTHETIC NON-PAIN INFORMATION. THIS WAS ACCOMPLISHED BY DIGITALLY SYNTHESIZING 16 DIFFERENT KINDS OF ACTION POTENTIALS ( WITH VARIABLE GEOMETRY ) VERY SIMILAR TO ENDOGENOUS ACTION POTENTIALS WHICH PRODUCE DIVERSE PERCEPTION EFFECTS DEPENDING ON THE “STRING SEQUENCE” THEY ARE ASSEMBLED IN OVER TIME, AND HOW THEY ARE MODULATED . SCRAMBLER THERAPY IS BASED ON PROFESSOR MARINEO’S RESEARCH THAT LED TO HIS DEVELOPMENT OF A NEW THEORY MODEL ON CHRONIC PAIN. THE MC-5A DEVICE IS ABLE TO TRANSMIT THROUGH DISPOSABLE SURFACE ELECTRODES SYNTHETIC NON-PAIN INFORMATION TO C-FIBER SURFACE RECEPTORS. THE EFFECTS OF THIS NEW INFORMATION ARE IMMEDIATE “ZEROING OUT” OF THE PAIN. IN THE TYPICAL TREATMENT CYCLE OF 10 SESSIONS PAIN IS PROGRESSIVELY REDUCED IN INTENSITY UNTIL COMPLETE RESOLUTION. THE PAIN RELIEF EFFECT IS LASTING. THE TREATMENT CAN BE REPEATED WHEN NEEDED. NO DESENSTIZATION OR ADVERSE SIDE EFFECTS HAVE BEEN RECORDED WITH PROPER USAGE OF THE DEVICE.

Psychological ConsultationData Analysis

• Frank R. Sparadeo, Ph.D. is a Clinical Neuropsychologist with over 30 years experience working in the rehabilitation of patients with Physical Trauma, Brain Trauma and Chronic Pain

• Dr. Sparadeo has been a consultant to several pain clinics including the RIH Interdisciplinary Spine Program, Southern New England Anaesthsiology and Pain Associates, and the Handel Spine Center.

• Dr. Sparadeo has developed a reliable pre-surgical pain evaluation that assists surgeons in determining prognosis of surgical outcome.

Experience

• Dr. Sparadeo developed a relationship with Calmar Pain Relief, LLC when he referred a patient that had over 40 invasive procedures for the treatment of his pain with no improvement whatsoever (Jan 2010).

• Dr. Sparadeo accompanied the patient to see Dr. D’Amato and witnessed this patient’s pain drop from a VAS of 9 to 0 within 3 minutes.

• Dr. Sparadeo has since been certified by CTT on the use of the ST device and has been allowed by the Calmar Pain Relief executive committee to conduct data collection and data analysis to document the efficacy of ST.

Full Sample by Treatment Session (247 Cases)

Full Sample By Session

T1 T2 T3 T4 T5 T6 T7 T8 T9 T10

7.2

5.85.1 4.9 4.9

4.5 4.5 4.54 4

2.82.1 1.8 1.9 1.7 1.7 1.6 1.7

1.1 1.3

Scrambler Therapy

Incoming Outgoing

ST by session INCOMING Pain VAS by Diagnosis

ST 1 ST 2 ST 3 ST 4 ST 5 ST 6 ST 7 ST 8 ST 9 ST 103

4

5

6

7

8

9

SpineLinear (Spine)CRPSLinear (CRPS)Complic'dLinear (Complic'd)

Spine N=47, Neuralgia N=13, CRPS N=27, Complicated N=43

ST by session Outgoing Pain VAS by Diagnosis

ST 1 ST 2 ST 3 ST 4 ST 5 ST 6 ST 7 ST 8 ST 9 ST 10

0

0.5

1

1.5

2

2.5

3

SpineLinear (Spine)CRPSLinear (CRPS)Complic'dLinear (Complic'd)

Axis Title

Spine N=47, CRPS N=27, Complicated N=43

Diagnosis X AgeDiagnosis N Mean Age

Spine-based pain 97 68

Neuralgia 41 63

Complex Regional Pain 46 44

Migraine 2 67

Multisite Complex cases 55 59

Pudendal 4 59

Other 2 67

TOTAL 247 60

Treatment Sessions X Dx (Incoming Pain VAS)

First Session Effect

6168

76

63

0102030405060708090

100

Spine Pain Neuralgia CRPS Multisite

Ave % chng

Ave % chng

3-6 Month Follow-upSuccess v. Failure on Incoming and Outgoing VAS

ST 1 ST 2 ST 3 ST 4 ST 5 ST 6 ST 7 ST 8 ST 9 ST 10

0

1

2

3

4

5

6

7

8

9

Success InSucc. OutFail inFail out

Axis Title

Success cases N=42, Failure cases N=12

Paired Comparisons

• The following slides take each diagnostic group and compare pre-treatment levels of pain impact to post-treatment (3-6 months following treatment) levels of the following variables:– VAS and General Activity Level– Psychosocial Variables (Mood, Joy, Interpersonal

Interactions and Sleep)– Maneuverability and Work/Household activity

Paired Comparisons

• All comparisons were paired T-tests (two-tailed)

• Spine pain and CRPS paired comparisons are all statistically significant (mostly P < .001)

• Paired comparisons made in the Complicated Multisite Pain group were not significant for VAS, Mood, Sleep, and Maneuverability

Paired Comparisons

• All comparisons were paired T-tests (two-tailed)

• Spine pain and CRPS paired comparisons are all statistically significant (mostly P < .001)

• Paired comparisons made in the Complicated Multisite Pain group were not significant for VAS, Mood, Sleep, and Maneuverability

Spine Pain(N=32)

Pre Tx Post Tx0

1

2

3

4

5

6

7

8

9

MoodInterpersJoySleep

Spine Pain(N=32)

Pre Tx Post Tx0

1

2

3

4

5

6

7

8

ManeuvWrk/Hshld

CRPS(N=20)

Pre Tx Post Tx0

1

2

3

4

5

6

7

8

9

VASGen Act

CRPS(N=20)

Pre Tx Post Tx0

1

2

3

4

5

6

7

8

MoodInterpersJoySleep

CRPS(N=20)

Pre Tx Post Tx0

1

2

3

4

5

6

7

8

ManeuvWrk/Hshld

Brief Pain Inventory SS Pre and PostPaired T-Test significant

VAS Pre and PostPaired T-Test significant

Pre Treatment & Post Treatment comparisons of the BPI Summary Score

46

35

52

40

2015 14

24

0

10

20

30

40

50

60

Spine Pain Neuralgia CRPS Multisite

Pre Tx

Followup

Pre Treatment & Post Treatment comparisons of the VAS

7.27.6 7.7 7.4

2.2 2.5 2.2

3.7

0

1

2

3

4

5

6

7

8

9

Spine Pain Neuralgia CRPS Multisite

Pre Tx

Followup

Average % of Pain Reduction at Follow-up

62.3 61

72

47

61

0

10

20

30

40

50

60

70

80

Spine Pain Neuralgia CRPS Multi Overall

%Pain Imp

%Pain Imp

Regression

• The combination of minimal to moderate sleep disturbance and a significant response to session one (pre treatment VAS minus the outgoing pain level) was significant and accounted for 21% of the variance across all diagnostic groups.

First Session Effect

6168

76

63

0102030405060708090

100

Spine Pain Neuralgia CRPS Multisite

Ave % chng

Ave % chng

COMPLICATED MULTI-SITE(N=19)

Pre Tx Post Tx0

1

2

3

4

5

6

7

VASGen Act

COMPLICATED MULTI-SITE(N=19)

Pre Tx Post Tx0

1

2

3

4

5

6

7

MoodInterpersJoySleep

COMPLICATED MULTI-SITE(N=19)

Pre Tx Post Tx0

1

2

3

4

5

6

ManeuvWrk/Hshld

Robin W. / Las Vegas, Nevada

Pre & Post ST Therapy – RSD Right Lower Extremity

Corrie , 30 Year Old Female / Houston, Texas

Pre & Post ST Therapy – RSD Right Lower Extremity

CONCLUSIONS

• ST demonstrates a significant treatment effect during each treatment session across multiple diagnoses.

• People who succeed seem to have a more significant treatment effect in the first four treatment sessions with the first treatment session % pain reduction predictive of long-term success.

• People with a diagnosis of CRPS have a 6 times greater likelihood of success than people with complicated multi-site pain sites

• People with a diagnosis of Spine Pain have a 2.5 times greater likelihood of success than people with complicated multi-site pain sites.

CONCLUSIONS

• Patients with chronic multi-site pain with multiple co-morbidities actually have a rapid improvement across the first four sessions followed by regression during the middle sessions and they finish with a strong reduction that does not hold in follow-up

• BPI results at follow-up suggest that patient’s treated with ST experience significant improvement in psychosocial functioning (increased activities, increased joy, improved mood).

CASE STUDYPATIENT E.B. (BCBSRI INSURANCE)

• 1) LYRICA 300 mg BID= 60/MNTH=$180.00• 2)MS CONTIN 15 mg BID=60/MNTH=$135.00• 3)OXYCODONE 5mgQID=120/MNTH=$135.00• _____________________________________• TOTAL SAVINGS=$450.00/MONTH

Large Scale Savings

• The average cost of either Spinal Cord Stimulator or medication pump is approximately $48,000

• The average cost of “re-surgery” in failed surgical cases is $106,000.

• The average cost of ST is $2,000.• The use of ST prior to the use of these elective

surgical procedures will be very cost effective since strong treatment effects in the first four sessions are highly predictive of long-term outcome. Overall success rates of ST are over 80%.

Large Scale Savings

• In 2010 Calmar Pain Relief was able to demonstrate a savings of well over $1 M across 30 patients considered candidates for SCS. The total cost for these 30 patients was estimated to be $1.4M. The total cost of the ST for these same 30 patients was approximately $60K.

• As a result of this demonstration Calmar Pain Relief, LLC was awarded a $250,000 federal grant for further development of the program.

Continued Success

• Through a comprehensive program evaluation that has demonstrated significant benefits to ST, Calmar Pain Relief, LLC has requested $24M from CMS/NIH to develop 9 additional clinics across the U.S. This project was encouraged by representatives of the Mayo Clinic, Johns Hopkins University, the Inventor of the technology (Marineo) and the manufactures of the technology (CTT).

• This project is the result of an RFP that has identified $1B for the development of innovative healthcare programs. We will be notified 3/31/12 should we be funded.

Questions & Answers