On the feasibility of using motor imagery EEG-based brain-computer interface in chronic tetraplegics for assistive robotic arm control: a clinical test and long-term post-trial follow-up.

STUDY DESIGN: Survey and long-term clinical post-trial follow-up (interviews/correspondence) on nine chronic, post spinal cord injury (SCI) tetraplegics. OBJECTIVE: To assess feasibility of the use of Electroencephalography-based Brain-Computer Interface (EEG-BCI) for reaching/grasping assistance in tetraplegics, through a robotic arm. SETTINGS: Physical and (neuromuscular) Rehabilitation Medicine, Cardiology, Neurosurgery Clinic Divisions of TEHBA and UMPCD, in collaboration with 'Brain2Robot' (composed of the European Commission-funded Marie Curie Excellence Team by the same name, hosted by Fraunhofer Institute-FIRST), in the second part of 2008. METHODS: Enrolled patients underwent EEG-BCI preliminary training and robot control sessions. Statistics entailed multiple linear regressions and cluster analysis. A follow-up-custom questionnaire based-including patients' perception of their EEG-BCI control capacity was continued up to 14 months after initial experiments. RESULTS: EEG-BCI performance/calibration-phase classification accuracy averaged 81.0%; feedback training sessions averaged 70.5% accuracy for 7 subjects who completed at least one feedback training session; 7 (77.7%) of 9 subjects reported having felt control of the cursor; and 3 (33.3%) subjects felt that they were also controlling the robot through their movement imagination. No significant side effects occurred. BCI performance was positively correlated with beta (13-30 Hz) EEG spectral power density (coefficient 0.432, standardized coefficient 0.745, P-value=0.025); another possible influence was sensory AIS score (range: 0 min to 224 max, coefficient -0.177, standardized coefficient -0.512, P=0.089). CONCLUSION: Limited but real potential for self-assistance in chronic tetraplegics by EEG-BCI-actuated mechatronic devices was found, which was mainly related to spectral density in the beta range positively (increasing therewith) and to AIS sensory score negatively.

Local tolerability and effectiveness of Ketospray® 10% cutaneous spray solution.

BACKGROUND: Orally administrated nonsteroidal anti-inflammatory drugs are effective in the treatment of a variety of acute and chronic pain conditions but their use may be associated with serious systemic adverse effects which are correlated with the therapeutic plasma levels of the drug. In order to minimize the incidence of drug related systemic events, topical formulations of the nonsteroidal anti-inflammatory drugs have been developed. A recently performed review of the evidence from randomized, double-blind, placebo controlled trials with topically applied NSAIDs in the treatment of acute pain confirmed the previously described pain relief effectiveness. For all topical nonsteroidal anti-inflammatory drugs combined, in comparison to placebo, the number needed to treat (NNT) to achieve a clinically meaningful pain relief of 50 % was 4.5 (3.9 to 5.3) for treatment periods of 6 to 14 days. Local skin reactions were generally mild and transient, and did not differ from placebo. OBJECTIVES: The present is an observational, multicenter, open-label, non-interventional, post-authorization safety study as it is defined by Article 21 of the European Clinical Trials Directive 2001/20/EC. The main objective of this study was to evaluate the local tolerability and the therapeutic efficacy of static and pain on movement intensity reduction of Ketospray® 10% cutaneous spray solution administered in accordance with the terms of the marketing authorization and last version of summary of product characteristics approved by National Medicines Agency of Romania. METHODS: In compliance with the Post-marketing study type, the assignment of the patient to a particular therapeutic strategy fell within current practice. The prescription of the medicine was not subject to compliance with predefined patients' characteristics. No specific, out of the daily practice routine diagnostic, monitoring, instrumental or laboratory assessments were foreseen by the study protocol. Patients' data were collected into respective case report forms. Study medication, Ketoprofen 10% Cutaneous Spray Solution was administered to the affected area at the dose of 3-6 spray puffs, 2-3 times a day, for 7 days. According to the study type, descriptive statistical methods were applied. Since almost half of the patients were treated with combination of the pain relieving medications, sizing of the pain relieving effects, as NNT, between the two groups was made. FINDINGS: There were 2020 study subjects in safety and ITT analysis population and 1802 (89%) in PP efficacy analysis population. There were 4 types of injuries: non-complicated strain-sprain (555), soft tissue contusion (323), low back pain (461) and osteoarthritis (681 patients). Ten patients reported 13 side effects of which 10 were recognized by investigators as adverse drug reactions. All side effects were non-serious, listed, application site skin changes. Remarkable reductions of static and pain on movement intensity were experienced by patients irrespective of the type of the injury and the type of the treatment. However, a clinically meaningful benefit of the concomitantly prescribed pain relieving medications was not observed for any type of pain. The lowest NNT (14) was obtained for the reduction of pain at rest in patients with strain-sprain or soft tissue contusions. The highest NNT (283) was for pain at rest in patients treated for the exacerbation of the chronic pain. CONCLUSIONS: The results of the current post-authorization study confirm beneficial pain intensity reducing efficacy of Ketospray 10% associated with good local tolerability of 7 days treatment course. Concomitant administration of systemic pain relieving medication did not substantially contribute neither to the relief of pain at rest nor of pain on movement among the subjects of respective study populations.

[Dan Alessandrescu's istmopexy technique and author's technique in grade III genital prolapse with urinary stress incontinence and vaginal vault prolapse. Comparative study]. / Istmopexia dan alessandrescu si tehnica autorului în prolapsul de gradul III asociat cu incontinenta urinara la efort si prolaps de bolta vaginala. Studiu comparativ.

UNLABELLED: The study is based on Polizu's Clinic experience and is an comparative analysis between Dan Alessandrescu's technic of istmopexy and a technique imagined by the author used in surgical treatment of genital prolapse grad III with urinary incontinence and vaginal vault prolapse. MATERIAL AND METHOD: From 2168 cases with genital prolapse pathology associated or not with UEI, 129 formed the refference lot which was treated with the two techniques: 85 (Dan Alessandrescu's istmopexy) and 45 (author's technique) for grade III genital prolapse associated with UEI. This study presents the statistics a surgical treatment of grade III uterine prolaps with urinary incontinence in Polizu Clinic during 15 years. RESULTS: When the new technique had been used a decrease of urinary incontinence recidives (from 7.1% to 6.7%) and enterocele (from 7.1% to 4.4%) have been observed. CONCLUSIONS: Postoperatory evolution shows the decrease of the recidives frequency.

Neuroprotective and consequent neurorehabilitative clinical outcomes, in patients treated with the pleiotropic drug cerebrolysin.

BACKGROUND: Discovery of neurotrophic factors--emblematic: the nerve growth factor (NGF)--resulted in better approaching central nervous system (CNS) lesions. Recently, another crucial property has been unveiled: their rather unique pleiotropic effect. Cerebrolysin is a peptide mixture that penetrates the blood-brain barrier in significant amounts and mimics the effects of NGF. METHODS: Comparative analysis: Cerebrolysin treated (10 ml x 2/day, i.v. x 3 weeks) vs. non-treated, in patients (all received aside, a rather equivalent complementary, pharmacological and physical, therapy). Two lots of patients, admitted in our Physical & Rehabilitation (neural-muscular) Medical-PR(n-m)M-Clinic Division, during 2007-2009: 69 treated with Cerebrolysin (22 F, 47 M; Average: 59.333; Mean of age: 61.0 Years old; Standard deviation 16.583) and 70 controls (41 F, 29 M; A: 70.014; M.o.a.: 70.5 Y.o.; S.d.: 6.270) were studied. The total number of assessed items was 13: most contributive in relation with the score of Functional Independence Measure at discharge (d FIM), were: admission (a FIM), number of physical therapy days (PT), number of hospitalization days (H), age (A) and--relatively--days until the first knee functional extension (KE). Concomitantly, the main/key, focused on neuro-motor rehabilitative outcomes, functional/analytical parameters, have been assessed regarding the speed in achieving their functional recovery. RESULTS: Concerning d FIM, there have not been objectified significant differences between the two lots (p=0.2453) but regarding key, focused on neuro-motor rehabilitative outcomes, functional/analytical parameters: KE (p=0.0007) and days until the first time recovery of the ability to walk between parallel bars (WPB--p=0.0000)--highly significant differences in favor of Cerebrolysin lot resulted. CONCLUSION: Cerebrolysin administration, as neurorehabilitative outcomes, proved to hasten, statistically significant, especially the recovery of some critical, for standing and walking, parameters. Thus encouraged, we have now initiated a comprehensive national, 5 year retrospective, multi-centre--based on unitary data acquisition frame and mathematical apparatus--study, to evaluate the results of the treatment with Cerebrolysin in traumatic brain injuries (TBI).