Transcranial Electrostimulation Via the Nexalin Device for Treatment of the Parkinson's Disease

Y. Katnelson¹, O. Balunov², E. Krupitsky², R. Pizinger¹, D. Rice¹, D. Zacharov², N. Safonova², P. Mokshancev², E. Verbitskaya³, T. Malkova<sup>1

1</sup>Kalaco Scientific, Inc., Scottsdale, AZ, USA, ²St. Petersburg Bechterev Research Psychoneurological Institute, ³St. Petersburg Pavlov State Medical University, St. Petersburg, Russia

In contrast to deep brain stimulation, the information concerning transcranial electrostimulation (TES) for treatment of Parkinson's disease (PD) is limited. TES is based on the activation of opioidergic systems of the brain. Disturbances in the production of endogenous opiates and serotonin could be one of the mechanisms underlying the development of PD. Presently, TES is widely used to treat depression, insomnia, and pain. The aim of this study was to evaluate the efficacy of the TES via "NEXALIN" device for treatment of PD. Twenty patients with mild and moderate PD were enrolled in a 5 week open label trial. Repeated clinical assessments, testing with UPDRS, and "Up and Go" were conducted during baseline (2 weeks), treatment (7 consecutive days; each session: 40 minutes, average current 15 mA) and follow up (2 weeks). All patients maintained their regular pharmacotherapy. Statistical and clinical improvements were noted in decreasing symptoms of hypersalivation, depression, and bradykinesia (p<0.05). Also observed were improvements in postural unsteadiness, stiffness, carriage, sleep, and mood. Decreases were noted in freezing when waking, facilitation of cutting of food and writing, and pain levels. The analysis of the "Up and Go" demonstrated decreased time (p<0.0001). Number of steps reduced after 7 sessions and the first week of follow up (p<0.0001). At final follow up the number of steps returned to the base level. No side effects were registered. The results of treatment of PD via the "NEXALIN" device proved some effectiveness of TES and could be the basis for future trials.

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Noninvasive activation of beta-endorphinergic system of the brain using "Nexalin" device for treatment of osteoarthritis pain

Poster Presentation--Pain and Disability
Abstract: P352

Citation: Osteoarthritis and Cartilage, Volume 14, Supplement B, page S189

Y. Katsnelson¹, R. Pizinger¹, D. Rice¹, D. Kelley¹, V. Lapshin², A. Khokhlov³, D. Barishev³, N. Bogdanova<sup>4

1</sup>Kalaco Scientific, Inc, Scottsdale, AZ, ²Department of Anesthesiology, Institute for Emergency Care, St. Petersburg, Russian Federation, ³Department of Clinical Pharmacology, Yaroslavl Medical Academy, Yaroslavl, Russian Federation, ⁴City Sport Clinic, St. Petersburg, Russian Federation

Purpose: Research supports that the direct activation of the Beta-Endorphinergic Systems (BES)could successfully decrease the level of pain experienced. The "NEXALIN" design uses a proprietary wave form (US Patent 6,904,322 B2), based on a quasi resonance frequency of 77.5 Hz. This frequency was confirmed in many prior Russian trials and studies, as being key to stimulating the increase in concentration of beta-endorphins in the brain, spinal fluid and blood (SU Patent #1522500). The aim is to prove the possibility of decreasing pain caused by osteoarthritis (OA) by using transcranial electrostimulation (TES) via the "NEXALIN" device.
Methods: The study was multi-centered, randomized, double-blind, and placebo-controlled. The study population consisted of 211 patients who had been diagnosed with OA of knee and/or hip, had a pain history of at least three months, and scored 4 or more on the Visual Score for Pain Assessment. The "NEXALIN" groups received 7 daily TES session of 40 minutes, 15 mA (root mean square); the placebo group received no stimulation using a visually identical device. Assessment methods: pain level (PL), patient global self-assessment (PGA), walking test (WT), physician's assessment (PA) - all utilizing visual scales. Assessments were performed prior to treatment, during the treatment series, and at the 1 year follow-up assessment.
Results: After 7 treatments: PL decreased in the "NEXALIN" group 57%, placebo 24% (p<10-9), WT 54% and 30% (P<10-4); PGA and PA increased respectively 47% and 25% (P<0.04), 44% and 32% (P<0.03). After 2 weeks: PL decreased in the "NEXALIN" group 40%, placebo 21% (p<10-4), WT 42% and 30% (P<0.01); PGA and PA increased respectively 29% and 25% (P<0.66), 42% and 30%(P<0.01). Statically analysis also showed decreasing of PL in the "NEXALIN" group during at least 6 weeks. The number and type of side effects were equivalent in both groups, with quantities in placebo exceeding active. Conclusions: "NEXALIN's" TES device, realized through activation of BES, provides significant and prolonged decrease in pain associated with OA.

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Treatment of osteoarthritis pain via transcranial electrostimulation of antinociceptive systems (ancs) of the brain using the Nexalin device

Y. Katsnelson¹, R. Pizinger¹, G. Bartoo², V. Lapshin³, A. Khokhlov⁴, D. Rice¹, N. Bogdanova⁵, T. Malkova¹, S. Chugunnaya⁴, D. Barishev<sup>4

1</sup>Kalaco Scientific, Inc., AZ, USA, ²Decus Biomedical, LLC, CA, USA, ³Department of Anesthesiology, Institute for Emergency Care, St. Petersburg, Russia, ⁴Department of Clinical Pharmacology, Yaroslavl Medical Academy, Yaroslavl, Russia, ⁵City Sport Clinic, St. Petersburg, Russia

Background and Aims: Activation of ANCS of the brain using a quasy resonance frequency of 77.5 Hz was proven effective in clinical and experimental studies. The Nexalin design uses a proprietary wave form based on 77.5 Hz. The result is Nexalin provides stimulation without sensation under electrodes (US Patent 6,904,322 B2). The aim is to determine the possibility of decreasing pain caused by osteoarthritis (OA) by using the Nexalin design.
Methods: 200+ patients with OA of knee and/or hip joints comprised the groups. The study was randomized, double-blind. The NEXALIN groups received 7 daily treatments of 40 minutes, 15 mA (root mean square); the placebo group received no stimulation using a visually identical device.
Assessment methods: pain level (PL), patient global self-assessment (PGA), walking test (WT), physician's assessment (PA) - all utilizing visual scales. Assessments were performed during three weeks prior, one week during, 2 weeks after the completion of treatment.
Preliminary Results: After 7 treatments: PL decreased in the NEXALIN group 57%, placebo 24% (p < 10-9), WT 54% and 30% (P < 10-4); PGA and PA increased respectively 47% and 25% (P < 0.04), 44% and 32% (P < 0.03).
After 2 weeks: PL decreased in the NEXALIN group 40%, placebo 21% (p < 10-4), WT 42% and 30% (P < 0.01); PGA and PA increased respectively 29% and 25% (P < 0.66), 42% and 30% (P< 0.01). The number and type of side effects were equivalent in both groups, with quantities in placebo exceeding active.
Conclusions: NEXALIN provides significant decrease of pain associated with OA and improvement in general condition.

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New cranial electrostimulation device Nexalin for pain treatment

Y. Katsnelson¹, D. Rice¹, G. Bartoo², V. Lapshin³, A. Khokhlov⁴, V. Danilova-Perley⁵, N. Bogdanova<sup>5

1</sup>Kalaco Scientific, Inc., Scottsdale, USA, ²Decus Biomedical, LLC, San Carlos, USA, ³Department of Anesthesiology, Institute for Emergency Care, St. Petersburg, Russia, St. Petersburg, Russia, ⁴Department of Clinical Pharmacology, Yaroslavl Medical Academy, Yaroslavl, Russia, ⁵City Sport Clinic, St. Petersburg, Russia

Aim of investigation: To determine the safety, efficacy, and decrease in pain level in patients suffering from osteoarthritis, by using the cranial electrostimulation (CES) device Nexalin®. Methods: The sample size included 206 subjects with osteoarthritis of the knee and/or hip, with a pain history > 3 months and a pain level > 4. The study was randomized, double-blind, and placebo controlled. Four clinical sites participated in this study. The active and placebo arms received 7 daily 40 minute treatment sessions. The placebo arm utilized an identical device that did not administer electrical stimulation. The current from the Nexalin device is not perceptible by the subject. Visual scales included: pain level; walking test; and physician's assessment. Assessments were completed during 3 weeks prior to treatment, 2 weeks after treatment, and 3 months following treatment. Additional measurements included: SF36; blood tests; neurological evaluations; psychological evaluations; and a medication usage log.
Results: Significant differences were noted between the active and placebo groups 2 weeks after Nexalin therapy: pain level - p < 0.0001; physician's assessment - p=0.02; pain during walking test - p=0.03. After 6 weeks the percentage of improvement (pain level) remained statistically significant. No serious adverse events were noted. The adverse events were similar for both the active and placebo arms.
Conclusions: Nexalin is safe and effective for the treatment of pain associated with osteoarthritis.

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Non - Invasive Pain Treatment with the Nexalin Cranial Electrotherapy Stimulation Device

Y.Katsnelson¹; G.Bartoo²; M.Bartoo²; V.Lapshin³; A.Ilina1; A.Khokhlov⁴; S.Chugunnaya⁴ SPON: Yakov Katsnelson

¹Kalaco Scientific, Inc, Scottsdale, AZ, USA; ²Decus Biomedical, LLC, San Carlos, CA, USA; ³Department of Anesthesiology, Institute for Emergency Care, St. Petersburg, Russian Federation; ⁴Department of Clinical Pharmacology, Yaroslavl Medical Academy, Yaroslavl, Russian Federation

Aim of Investigation: A newly developed cranial electrostimulation (CES) device, NEXALIN, was tested for efficacy of pain relief in subjects suffering from osteoarthritis.
Methods: The study was a prospective, double-blind, randomized, and controlled. The safety and effectiveness of two active Nexalin waveforms were compared to a sham treatment. A total of 140 subjects from three separate sites completed the study. The subject population consisted of adult men and women who had objective evidence of osteoarthritis, had experienced pain for at least 3 months, and self-assessed their level of pain of at least 4 out of 10 on the Visual Scale for pain. The active groups received daily 40 minute treatments of CES for 7 days, using either the symmetric or asymmetric NEXALIN waveform. The sham group received 7 treatments using an identical device that was programmed to provide no CES. Because there is minimal or no sensation with either form of active treatment, subject blinding was not compromised. Assessments were performed during a baseline (two weeks), during the week of treatment, and at least one week after the completion of active or sham treatment.
Results: Pain levels decreased 34% in the sham group, 48% in asymmetric and 51% in the symmetric group (p< 0.03 between symmetric and sham groups); and decreased by at least 75% in 9%, 28.6% and 23.8% of patients respectively. Contrast tests for % improvement showed a statistical difference only between symmetric and sham groups. Statistically significant decrease in rescue medication usage was noted only in the symmetric group. Physician's assessments also noted a significant improvement in condition only in the symmetric group, as compared to sham group (p< 0.01).
Conclusions: Treatment with the symmetric waveform of the NEXALIN led to a significant decrease of pain intensity and decrease in analgesic rescue medication usage when compared to sham treatment. NEXALIN can be an effective alternative to pharmacological methods of pain treatment.

Citation: Y.Katsnelson, G.Bartoo, M.Bartoo, V.Lapshin, A.Ilina, A.Khokhlov, S.Chugunnaya. Non - Invasive Pain Treatment with the Nexalin Cranial Electrotherapy Stimulation Device. Program No. 1731-P234. 2005 Abstract Viewer. Sydney, Australia: International Association for the Study of Pain

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Temporary pain relief using transcranial electrotherapy stimulation: results of a randomized, double-blind pilot study

Katsnelson Y, Khokhlov A, Tsvetkov V, Bartoo G, Bartoo M.

Kalaco Sci., Inc., Scottsdale, AZ, USA.

Results of a randomized, double-blind pilot study indicate that transcranial electrotherapy stimulation may be an effective treatment for the temporary reduction of pain in osteoarthritis patients. Presently, the predominant method for pain management is medication. One very different approach is the application of micro- to milliamp current applied to specific areas of the head, resulting in a release of endogenous opioids from pain management regions of the brain. For the pilot study, 64 subjects suffering from osteoarthritis of the knee and/or hip were enrolled. For two weeks prior, then during and after treatment, subject pain was self-assessed using the visual scale (VS). In addition, subjects were globally assessed by a physician. All subjects, device operators and physicians were blinded as to whether subjects were treated with an active or sham device. Data collected from the study indicate both a decrease in VS pain scores and a significant improvement (p = 0.05) in physician assessment in subjects treated with active devices compared to those treated with the sham device.

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Psycho-emotional condition while treating pain syndromes using "TESA" device

L. Lapshina², Y. Katsnelson¹, V. Lapshin², I. Strahov², A. Razumov², R. Katsnelson<sup>1

1</sup>Kalaco Scientific, Inc., Scottsdale, AZ, USA, ²Scientific Research Institute of Emergency Care, St. Petersburg, Russia

The evaluation of psychological status during treatment of pain syndrome was accomplished using Luscher's test as a tool of early diagnostics psychological and somatic stress, and the mathematical analysis of cardiac rhythm (MACR) for the evaluation of processes of regulation and adaptation. The treatment of pain syndrome was accomplished using transcranial electrostimulation (TES) via "TESA" device (Kalaco Scientific, USA). In the first group (n=15) tests were performed before and after one 30 minute session of TES; in the second group (n=12) - before and after 30 minute sessions for the duration of 5 days.

1. Intensity of pain level (PL) was determined on a visual analog scale (10 grades); the man being 5.95. After the first session the intensity of PL decreased by 45% and continued to decrease every following day. At the end of the treatment, the PL was 1.75 (P< 0.05).
2. IN 75% of subjects of both groups, a steady decrease (p< 0.05) of the factor of uneasiness (FU) was marked; in 23% tendency to the decreasing of FU and only in 2% did the level of FU not change.
3. A correlation was found between PL and FU and reverse correlation between PL, FU and factor capability to work.
4. The level of parameters of MACR (adaptation, vegetative regulation, central regulation, psycho-emotional conditions) was increased (p< 0.05) after the first session and continued to normalize until the end of TES course.
"TESA" brings about not only an analgesic effect but also the normalization of psychological status.

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