Effectiveness of an Innovative Pulsed Electromagnetic Fields Stimulation in Healing of Untreatable Skin Ulcers in the Frail Elderly: Two Case Reports.

Introduction. Recalcitrant skin ulcers are a major burden in elderly patients. Specifically, chronic wounds result in significant morbidity and mortality and have a profound economic impact. Pulsed electromagnetic fields (PEMFs) have proved to be a promising therapy for wound healing. Here we describe the first reported case of an innovative PEMF therapy, Emysimmetric Bilateral Stimulation (EBS), used to successfully treat refractory skin ulcers in two elderly and fragile patients. Case Presentation. Two elderly patients developed multiple chronic skin ulcerations. Despite appropriate treatment, the ulcers showed little improvement and the risk of amputation was high. Both patients underwent daily EBS therapy and standard dressing. After few weeks of treatment, major improvements were observed and all ulcers had healed. Conclusion. In patients with refractory ulceration, EBS therapy may be of real benefit in terms of faster healing. This case supports the supportive role for PEMFs in the treatment of skin ulceration in diabetes and is suggestive of a potential benefit of EBS in this clinical condition.

An innovative intervention for the treatment of cognitive impairment-Emisymmetric bilateral stimulation improves cognitive functions in Alzheimer's disease and mild cognitive impairment: an open-label study.

BACKGROUND AND AIMS: In the last decade, the development of different methods of brain stimulation by electromagnetic fields (EMF) provides a promising therapeutic tool for subjects with impaired cognitive functions. Emisymmetric bilateral stimulation (EBS) is a novel and innovative EMF brain stimulation, whose working principle is to introduce very weak noise-like stimuli through EMF to trigger self-arrangements in the cortex of treated subjects, thereby improving cognitive faculties. The aim of this pilot study was to investigate in patients with cognitive impairment the effectiveness of EBS treatment with respect to global cognitive function, episodic memory, and executive functions. METHODS: Fourteen patients with cognitive decline (six with mild cognitive impairment and eight with Alzheimer's disease) underwent three EBS applications per week to both the cerebral cortex and auricular-specific sites for a total of 5 weeks. At baseline, after 2 weeks and 5 weeks, a neuropsychological assessment was performed through mini-mental state examination, free and cued selective reminding tests, and trail making test. As secondary outcomes, changes in behavior, functionality, and quality of life were also evaluated. RESULTS: After 5 weeks of standardized EBS therapy, significant improvements were observed in all neurocognitive assessments. Mini-mental state examination score significantly increased from baseline to end treatment (+3.19, P=0.002). Assessment of episodic memory showed an improvement both in immediate and delayed recalls (immediate recall =+7.57, P=0.003; delayed recall =+4.78, P<0.001). Executive functions significantly improved from baseline to end stimulation (trail making test A -53.35 seconds; P=0.001). Of note, behavioral disorders assessed through neuropsychiatric inventory significantly decreased (-28.78, P<0.001). The analysis concerning the Alzheimer's disease and mild cognitive impairment group confirmed a significant improvement of cognitive functions and behavior after EBS treatment. CONCLUSION: This pilot study has shown EBS to be a promising, effective, and safe tool to treat cognitive impairment, in addition to the drugs presently available. Further investigations and controlled clinical trials are warranted.

Neuropsychophysical optimization by REAC technology in the treatment of: sense of stress and confusion. Psychometric evaluation in a randomized, single blind, sham-controlled naturalistic study.

PURPOSE: The aim of this study is to investigate the effects of neuropsychophysical optimization (NPPO) protocol treatment by radioelectric asymmetric conveyer (REAC) technology in the management of sense of stress and confusion (SSC); an analysis of a single cluster of the psychological stress measure (PSM) test. PATIENTS AND METHODS: The PSM, a self-administered questionnaire, was used to measure psychological stress and SSC for a group of 888 subjects. Data were collected immediately prior to and following the 4-week REAC-NPPO treatment cycle. RESULTS: This study demonstrates a significant reduction in scores measuring subjective perceptions of stress for subjects treated with one cycle of REAC-NPPO. At the end-point of the study, the number of treated subjects reporting symptoms of stress-related SSC on the PSM test was significantly reduced, whereas there was no difference in sham-treated subjects. CONCLUSION: One cycle of REAC-NPPO appears to reduce subjective perceptions of SSC measured by the PSM. TRIAL REGISTRATION: This trial has been registered in the Australian New Zealand Clinical Trials Registry as ACTRN12607000497404.

Noninvasive brain stimulation by radioelectric asymmetric conveyor in the treatment of agoraphobia: open-label, naturalistic study.

BACKGROUND: Agoraphobia is considered to be the most serious complication of panic disorder. It involves progressive development of debilitating anxiety symptoms related to being in situations where one would be extremely embarrassed and could not be rescued in the case of a panic attack. This study aimed to investigate the efficacy of noninvasive brain stimulation using a radioelectric asymmetric conveyor (REAC) for agoraphobia. PATIENTS AND METHODS: Twenty-three patients (3 males and 20 females) suffering from agoraphobia and without a history of panic disorder were evaluated by a psychiatrist using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, and the Agoraphobia Scale (AS). The patients were subjected to two 18-session cycles of noninvasive brain stimulation with the REAC, according to an established therapeutic protocol called neuropsycho-physical optimization. RESULTS: Analyzing the anxiety and avoidance parameters of the AS after the first and second cycles of REAC treatment revealed variation in levels of response to treatment, including weak (AS item 7), moderate (AS items 10 and 13), and good responses (AS items 1-6, 8, 9, 11, 12, and 14-20). CONCLUSION: These results highlight the potential of the REAC to treat complex clinical situations such as agoraphobia, which is typically resistant to pharmacologic treatments. Furthermore, these data show the advantages of REAC treatment, even compared with modern cognitive behavioral therapy, including a relatively rapid and "stable" clinical response (just over 6 months) and economic cost.

Social anxiety disorder: radio electric asymmetric conveyor brain stimulation versus sertraline.

PURPOSE: Social anxiety disorder (SAD) is a disabling condition that affects almost 5% of the general population. Many types of drugs have shown their efficacy in the treatment of SAD. There are also some data regarding psychotherapies, but no data are available today about the efficacy of brain stimulation techniques. The aim of the study is to compare the efficacy of noninvasive brain stimulation neuro psycho physical optimization (NPPO) protocol performed by radio electric asymmetric conveyor (REAC) with that of sertraline in adults with SAD. PATIENTS AND METHODS: Twenty SAD patients on sertraline were compared with 23 SAD patients who refused any drug treatment and who chose to be treated with NPPO-REAC brain stimulation. This was a 6-month, open-label, naturalistic study. Patients on sertraline received flexible doses, whereas NPPO-REAC patients received two 18-session cycles of treatment. Clinical Global Improvement scale items "much improved" or "very much improved" and Liebowitz Social Anxiety Scale total score variation on fear and avoidance components were used to detect the results. The statistical analysis was performed with t-test. All measures <0.05 have been considered statistically significant. RESULTS: Ten of 23 subjects on NPPO-REAC and six of the 20 taking sertraline were much improved or very much improved 1 month after the first NPPO-REAC cycle (t1). Sixteen of the subjects on NPPO-REAC and ten of the subjects taking sertraline were much improved or very much improved 1 month after the second NPPO-REAC cycle (t2). In respect of the Liebowitz Social Anxiety Scale, at t1 NPPO-REAC resulted in statistically more efficacy for sertraline on both fear and avoidance total scores. At t2, NPPO-REAC resulted in statistically more efficacy for sertraline on fear but not on avoidance. CONCLUSION: NPPO-REAC is an effective treatment for SAD, allowing substantial and clinically meaningful reductions in symptoms and disability in comparison with sertraline.

Noninvasive radioelectric asymmetric brain stimulation in the treatment of stress-related pain and physical problems: psychometric evaluation in a randomized, single-blind placebo-controlled, naturalistic study.

BACKGROUND: The aim of this study was to investigate the effects of noninvasive radioelectric asymmetric conveyer brain stimulation (REAC-BS) on pain and physical problems, a measurement cluster of the Psychological Stress Measure (PSM) test. When the symptoms of pain and physical problems do not respond to various therapeutic approaches such as medication, physiotherapy, and psychotherapy, they are often called medically unexplained symptoms. As such, these symptoms are reported to be a response to stressful situations or emotional states, often unknown to patients themselves. To explore the effectiveness of noninvasive radioelectric brain stimulation in the amelioration of symptoms of pain and physical problems, we administered a neuropsychophysical optimization protocol using a REAC device. METHODS: The PSM, a self-administered questionnaire, was used to measure psychological stress and pain and physical problems in a group of 888 subjects. Data were collected immediately prior to and following a 4-week REAC treatment cycle. RESULTS: There was a significant reduction in scores measuring subjective perceptions of stress for subjects treated with one cycle of neuropsychophysical optimization REAC-BS. At the end of the study, the number of treated subjects reporting symptoms of stress-related pain and physical problems on the PSM test was significantly reduced, whereas there was no difference in placebo-treated subjects. CONCLUSION: One cycle of neuropsychophysical optimization REAC-BS appears to reduce subjective perceptions of stress as measured by the PSM, particularly on the pain and physical problems cluster.

Radioelectric asymmetric stimulation of tissues as treatment for post-traumatic injury symptoms.

BACKGROUND: For the past few years, treatment of contusions and associated symptoms, such as bruising, pain, and loss of function, has involved instrument-based therapies, ie, lasers, electromagnetic fields, and electrical stimulation. In this study, tissue optimization (TO) sessions were applied using a radioelectric asymmetric conveyor (REAC) for the treatment of contusions and associated symptoms. METHODS: Six subjects were treated with 12-18 sessions of REAC-TO applied to a traumatized anatomical area. RESULTS: In all cases, REAC-TO sessions were found to be effective for the treatment of post-traumatic injuries involving hematomas, hemorrhagic suffusion, and loss of function. In addition, REAC-TO treatments represented a rapid-acting analgesic associated with antiedematous, anti-inflammatory, and regenerative effects. These findings are consistent with the results of previous studies, and confirm the capacity of REAC-TO to provide almost immediate recovery of function in traumatized areas. CONCLUSION: As previously demonstrated in vitro, REAC-TO is able to promote regeneration and repair processes in the human body. For six subjects experiencing local trauma, REAC-TO was effective in speeding the healing time of contusion symptoms and providing recovery of function.

Radio electric tissue optimization in the treatment of surgical wounds.

PURPOSE: To report preliminary results with the tissue optimization (TO) treatment with a radio electric asymmetric conveyer (REAC) in promoting the repair of surgical wounds. PATIENTS AND METHODS: Two subjects, a 54-year-old male with a tear bruise on the upper third of the leg and a 19-year-old female with a stab wound to the hand, were treated with 12 REAC-TO treatment sessions. RESULTS: In both patients, the wounds showed shorter healing time compared with the time usually required for similar wounds, and good repair quality. CONCLUSION: REAC device with its specific treatment protocols may be an alternative therapy for wound healing.

Radioelectric asymmetric brain stimulation and lingual apex repositioning in patients with atypical deglutition.

BACKGROUND: Atypical deglutition is exacerbated by stress and anxiety. Several therapeutic approaches have been employed to treat stress and anxiety disorders, ranging from typical psychopharmacological strategies to novel physical protocols, such as transcranial magnetic stimulation and radioelectric asymmetric conveyor (REAC) stimulation. The purpose of the present study was to test the efficacy of REAC brain stimulation in atypical deglutition. METHODS: The position of the lingual apex (Payne method), pattern of free deglutition, and subjective and objective impression of deglutition were evaluated in 128 outpatients suffering from atypical deglutition. Deglutition testing consisted of an operator holding down the lower lip, hence counteracting the strength exerted by the orbicularis muscle. All subjects were treated using two REAC brain stimulation protocols. Patients were assessed before treatment, immediately after treatment, and three months following the last cycle of REAC therapy. RESULTS: REAC stimulation led to an improvement in positioning of the lingual apex and a significant decrease of muscle involvement in all patients immediately after REAC treatment, and the improvement was maintained at three-month follow-up. CONCLUSION: In the present study, the REAC therapeutic protocols led to normalization in lingual apex positioning and significant improvement in swallowing in all participants suffering from atypical deglutition.

Comparison of two treatments for coxarthrosis: local hyperthermia versus radio electric asymmetrical brain stimulation.

BACKGROUND: It is well known that psychological components are very important in the aging process and may also manifest in psychogenic movement disorders, such as coxarthrosis. This study analyzed the medical records of two similar groups of patients with coxarthrosis (n = 15 in each) who were treated in two different clinics for rehabilitation therapy. METHODS: Patients in Group A were treated with a course of traditional physiotherapy, including sessions of local hyperthermia. Group B patients were treated with only a course of radioelectric asymmetrical brain stimulation (REAC) to improve their motor behavior. RESULTS: Group A showed a significant decrease in symptoms of pain and stiffness, and an insignificant improvement in range of motion and muscle bulk. A single patient in this group developed worsened symptoms, and pain did not resolve completely in any patient. The patients in Group B had significantly decreased levels of pain and stiffness, and a significant improvement in range of motion and muscle bulk. No patients worsened in Group B, and the pain resolved completely in one patient. CONCLUSION: Both treatments were shown to be tolerable and safe. Patients who underwent REAC treatment appeared to have slightly better outcomes, with an appreciable improvement in both their physical and mental states. These aspects are particularly important in the elderly, in whom functional limitation is often associated with or exacerbated by a psychogenic component.

Radio electric asymmetric brain stimulation in the treatment of behavioral and psychiatric symptoms in Alzheimer disease.

PURPOSE: Behavioral and psychiatric symptoms of dementia (BPSD) are common in Alzheimer's disease (AD) and disrupt the effective management of AD patients. The present study explores the use of radio electric asymmetric brain stimulation (REAC) in patients who have had a poor response to pharmacological treatment. PATIENTS AND METHODS: Eight patients (five females and three males; mean [±standard deviation] age at study baseline: 69.9 ± 3.0 years) diagnosed with AD according to the DSM-IV-TR criteria (mean onset age of AD: 65.4 ± 3.5 years) were cognitively and psychometrically assessed with the Mini-Mental State Examination (MMSE), the Activity of Daily Living (ADL), the Instrumental Activity of Daily Living (IADL), and the Neuropsychiatric Inventory (NPI), prior to and after each of 2 REAC treatment cycles. RESULTS: Scores on the MMSE and all subscales of the NPI (frequency, severity, and distress), the ADL, and the IADL were significantly improved following the initial REAC treatment. There was further significant improvement in all measurements (with a tendency for improvement in the IADL) after the second REAC treatment cycle. CONCLUSION: The improvement of cognitive and behavioral/psychiatric functioning following REAC treatment suggests that this innovative approach may be an effective, safe, and tolerable alternative to pharmacological treatment of AD patients, especially in the area of BPSD. Elderly patients suffering from other types of dementia may also benefit from REAC treatment.

Long-term treatment of bipolar disorder with a radioelectric asymmetric conveyor.

BACKGROUND: The bipolar spectrum disorders are considered an important and frequent psychiatric problem. The clinical complexity of these illnesses due to the coexistence of depressive and excitative phases is correlated with the global difficulty of adequate treatment; consequently, the prognosis is not optimal. For this reason, in recent years, novel nonpharmacologic physical approaches have been tested for bipolar disorders, with encouraging results. The aim of this study was to evaluate the long-term effectiveness of a radioelectric asymmetric brain stimulation device associated with lithium (REAC-lithium) versus previous treatments in subjects with bipolar disorder I or II, evaluated as the number of recurrences compared with the period of illness preceding treatment with REAC-lithium. METHODS: The charts of 56 bipolar patients attending our institute were retrospectively evaluated. Treatment with REAC-lithium was administered following the standard Rinaldi-Fontani Institute protocol. Add-on treatments were allowed in the event of manic or depressive recurrence. Eight patients (Group 1) were followed for 30.2 ± 3.0 months, 14 patients (Group 2) were followed for 25.3 ± 3.3 months, 25 patients (Group 3) were followed for 20.3 ± 1.6 months, and nine patients (Group 4) were followed for 16.2 ± 0.5 months. RESULTS: After REAC-lithium treatment, the number of manic and depressive episodes in Group 1 decreased from 2.1 ± 0.6 and 3.0 ± 0.7 to 0.12 ± 0.0 and 0.8 ± 0.4, respectively. In Group 2, the number of manic and depressive episodes decreased from 2.4 ± 0.6 and 3.9 ± 0.7 to 0.14 ± 0.2 and 0.0 ± 0.0, respectively. In Group 3, the number of manic and depressive episodes decreased from 2.6 ± 0.8 and 3.6 ± 0.9 to 0.04 ± 0.0 and 0.0 ± 0.0, respectively. In Group 4, the number of manic and depressive episodes decreased from 2.6 ± 1.1 and 3.7 ± 1.0 to 0.1 ± 0.0 and 0.0 ± 0.0, respectively. All results were statistically significant. CONCLUSION: REAC showed good efficacy in treating both the manic and depressive phases of bipolar disorder, and in the prevention of recurrences/relapses.

Radioelectric brain stimulation in the treatment of generalized anxiety disorder with comorbid major depression in a psychiatric hospital: a pilot study.

BACKGROUND: Generalized anxiety disorder (GAD) is often presented with major depression (MD). GAD-MD can be a chronic and disabling condition, and patients suffering from this disorder often respond poorly to psychopharmacological treatment and experience side effects with medication. Therefore, there is a high demand for effective nonpharmacological therapy for GAD-MD patients. The current study explores the use of a radioelectric asymmetric conveyer (REAC) device in the treatment of GAD-MD. METHODS: Participants were 24 patients diagnosed with GAD-MD being treated at a public psychiatric center. All patients were dissatisfied with their current pharmacological treatment. Patients were evaluated using the 21-item Hamilton Depression (HAM-D) rating scale and the Symptom Check List-90-Revised (SCL-90R) before and after REAC brain stimulation treatment cycles. RESULTS: After REAC brain stimulation treatment, all patients experienced a significant reduction in anxiety and depression. These results were confirmed by physician examination, HAM-D scores, and SCL-90R total scores. CONCLUSION: These results indicate a role for REAC brain stimulation in the management of psychiatric conditions, specifically, GAD-MD comorbidity. REAC treatments are synergistic to drug therapy and appear to be helpful in reducing the side effects of medication. Future studies should evaluate the long-term effects of REAC treatment.

Stress-related psycho-physiological disorders: randomized single blind placebo controlled naturalistic study of psychometric evaluation using a radio electric asymmetric treatment.

BACKGROUND: The aim of this study is to investigate the effects of a radio electric asymmetric treatment on psycho-physiological disorders (PPD). PPD are often stress related and are under the unconscious control of the patient and cannot be traced back to any serious physical disease. The brain stimulation treatment protocol used is called Neuro Psycho Physical Optimization (NPPO) with a Radio Electric Asymmetric Conveyer (REAC) device. METHODS: Psychological stress and PPD were measured for a group of 888 subjects using the Psychological Stress Measure (PSM) test, a self-administered questionnaire. Data were collected immediately before and after the 4-weeks of REAC treatment cycle. RESULTS: This study showed a significant reduction in scores measuring subjective perceptions of stress for subjects treated with a cycle of NPPO REAC treatment. At the end-point the number of subjects reporting symptoms of stress-related PPD on the PSM test was significantly reduced, whereas in the placebo group the difference was not significant. CONCLUSION: A cycle of NPPO treatment with REAC was shown to reduce subjective perceptions of stress measured by the PSM test and in particular on PPD. TRIAL REGISTRATION: This trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with the number: ACTRN12607000463471.

Does osteoarthritis of the knee also have a psychogenic component? Psycho-emotional treatment with a radio-electric device vs. intra-articular injection of sodium hyaluronate: an open-label, naturalistic study.

This study is to compare, in patients suffering of knee joint disorder, the effects of intra-articular injection of Sodium Hyaluronate, and those of a treatment aiming at the improvement of the emotional status carried out by means of a Radio Electric Device (REAC). 30 subjects were divided into two groups: 15 who preferred a non-drugs approach (Group A) and 15 who preferred an infiltrative treatment (Group B). The evaluations were expressed for both pain level and knee bending and extension. Group A showed significant decrease in pain, stiffness, joint noises and intra-articular effusion, and significant improvement in motion range, without any patients worsening. 8 patients showed complete disappearance of pain in Visual Analog Pain Scale (VAS) evaluation, evident by a level of 0. The initial VAS results were between 8 and 4. One month after treatment's end, VAS results of the patients in Group A were between 3 and 0. Group B showed significant decrease in pain, stiffness, joint noises and intra-articular effusion, but no significant improvement in motion range; 2 of 15 patients showed worsening symptoms and no significant improvement in muscular hypotrophy. Initial VAS results were between 7 and 4. One month after treatment's end, VAS results were between 6 and 0.

Psychometric evaluation of a radio electric auricular treatment for stress related disorders: a double-blinded, placebo-controlled controlled pilot study.

BACKGROUND: The aim of this double-blind randomized study is to test the efficacy of a radio electric stimulator device using an auricular reflex therapy protocol for stress-related symptoms. METHODS: The study has been carried out on 200 subjects (138 females, 62 males) that voluntarily came to our Institute declaring to "feel stressed".The participants were randomly allocated with a computerized procedure: 150 were treated with auricular therapeutic protocol with radio electric stimulator device (REAC) and 50 were treated with an inactivated, placebo REAC. Psychological stress was evaluated trough the self-administered questionnaire Psychological Stress Measure (PSM). Assessment data were collected at 2 time points: before the treatment (T0) and immediately after the therapy cycle of 18 sessions about 4 weeks later (T1). RESULTS: In the group treated with REAC, the psychometric evaluation after the therapy's cycle showed a significant reduction of PSM total scores, from 107.8 +/- 23,13 at T0 to 87.1 +/- 16,21 at T1 (p < 0.5), while in the control group no significant variation in decreasing stress-related symptomatology has been noted (107.86 +/- 25,80 at T0 and 106.32 +/- 25,88 at T1 (p = NS). CONCLUSIONS: The protocol of the auricular treatment with REAC seems to reduce the subjective perception of stress, as "psychometrically" demonstrated by the significant reduction in PSM test total score. This therapeutical procedure also provides a non invasive, not painful and very simple innovative approach to treat the widely diffused stress related disorders. TRIAL REGISTRATION: This trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with the number: ACTRN12607000529448.

Radio electric treatment vs. Es-Citalopram in the treatment of panic disorders associated with major depression: an open-label, naturalistic study.

Simultaneous coexistence of anxiety with depressive disorders is probably one of the major current problems in Medicine. The pharmacological approach for Panic Disorder and Major Depression includes "high-powered" benzodiazepines for the rapid, but transitory relief of same symptoms and especially antidepressant compounds. Recently physical-instrumental approaches have been tested for the treatment of these complex diseases, like Cranial Electrotherapy Stimulation (CES), Trans-cranial Magnetic Stimulation (TMS), and Radio Electric Asymmetric Treatment (REAC). The REAC apparatus was designed to deliver an alternate current of several hundred picoamperes for a time span of 0.5 seconds by means of a small metallic probe directly connected to the properly fabricated electronic circuit in an AC/RF generator with frequency of 2.4, 5.8 or 10.5 GHz and power of 20 mW. Compared the efficacy of REAC and Es-Citalopram in the treatment of simultaneous coexistence of Panic Disorder with Major Depression in 9-weeks open label naturalistic study. After the 1st week, patients treated with REAC therapy showed a significant relief of depressive symptoms compared with Es-Citalopram. For Panic Disorder, REAC treatment had more effective results than the drug especially after the 3rd week of observation. The REAC treatment obtained better results during the entire study, and its high safety and tolerability profile has been confirmed.