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https://www.readbyqxmd.com/read/27584814/comparison-of-10-khz-high-frequency-and-traditional-low-frequency-spinal-cord-stimulation-for-the-treatment-of-chronic-back-and-leg-pain-24-month-results-from-a-multicenter-randomized-controlled-pivotal-trial
#1
Leonardo Kapural, Cong Yu, Matthew W Doust, Bradford E Gliner, Ricardo Vallejo, B Todd Sitzman, Kasra Amirdelfan, Donna M Morgan, Thomas L Yearwood, Richard Bundschu, Thomas Yang, Ramsin Benyamin, Abram H Burgher
BACKGROUND: Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy...
September 6, 2016: Neurosurgery
https://www.readbyqxmd.com/read/27228514/high-frequency-spinal-cord-stimulation-at-10-khz-for-the-treatment-of-chronic-pain-6-month-australian-clinical-experience
#2
Marc Russo, Paul Verrills, Bruce Mitchell, John Salmon, Adele Barnard, Danielle Santarelli
BACKGROUND: High frequency spinal cord stimulation at 10 kHz (HF10 therapy) represents a prominent advance in spinal cord stimulation (SCS) therapy, having demonstrated enhanced efficacy in patients with back and leg pain and pain relief without paresthesia that is sustained at 24 months post implant. OBJECTIVE: To report on the effectiveness HF10 SCS therapy for a wide range of intractable pain conditions in clinical practice. STUDY DESIGN: Retrospective investigation of 256 patients who trialed HF10 SCS for chronic intractable pain of various etiologies...
May 2016: Pain Physician
https://www.readbyqxmd.com/read/26218762/novel-10-khz-high-frequency-therapy-hf10-therapy-is-superior-to-traditional-low-frequency-spinal-cord-stimulation-for-the-treatment-of-chronic-back-and-leg-pain-the-senza-rct-randomized-controlled-trial
#3
RANDOMIZED CONTROLLED TRIAL
Leonardo Kapural, Cong Yu, Matthew W Doust, Bradford E Gliner, Ricardo Vallejo, B Todd Sitzman, Kasra Amirdelfan, Donna M Morgan, Lora L Brown, Thomas L Yearwood, Richard Bundschu, Allen W Burton, Thomas Yang, Ramsin Benyamin, Abram H Burgher
BACKGROUND: Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain...
October 2015: Anesthesiology
https://www.readbyqxmd.com/read/26182034/188%C3%A2-randomized-controlled-clinical-trial-evaluating-the-safety-and-effectiveness-of-10-khz-high-frequency-and-traditional-low-frequency-stimulation-for-the-treatment-of-chronic-back-and-leg-pain-18-month-results
#4
Leonardo Kapural, Cong Yu, Matthew W Doust, Bradford E Gliner, Ricardo Vallejo, B Todd Sitzman, Kasra Amirdelfan, Donna M Morgan, Lora L Brown, Thomas L Yearwood, Richard Bundschu, Allen Burton, Thomas Yang, Ramsin Benyamin, Abram H Burgher
INTRODUCTION: A randomized controlled trial with appropriate statistical power and long-term outcomes is the hallmark of level 1 clinical evidence. The SENZA-RCT multicenter pivotal study was powered to directly compare highfrequency spinal cord stimulation (SCS) at 10 kHz (HF10 therapy) and traditional lowfrequency (∼50 Hz) SCS. The comparative efficacy of these modalities for the treatment of chronic back and leg pain for 18 months is presented. METHODS: Baseline assessments were performed before the randomization of 198 patients...
August 2015: Neurosurgery
https://www.readbyqxmd.com/read/26176043/phase-i-dose-escalation-clinical-trial-of-hf10-oncolytic-herpes-virus-in-17-japanese-patients-with-advanced-cancer
#5
Hideki Kasuya, Yasuhiro Kodera, Akimasa Nakao, Kazuo Yamamura, Tan Gewen, Wu Zhiwen, Yoshihiro Hotta, Suguru Yamada, Tsutomu Fujii, Saori Fukuda, Naoko Tsurumaru, Toshie Kuwahara, Toyone Kikumori, Yusuke Koide, Yasushi Fujimoto, Tsutomu Nakashima, Yoshiki Hirooka, Hiroshi Shiku, Maki Tanaka, Kazuto Takesako, Touru Kondo, Branko Aleksic, Hiroki Kawashima, Hidemi Goto, Yukihiro Nishiyama
Oncolytic virus therapy is a promising new therapeutic method, one of an eagerly anticipated class of biological therapies against cancer. There are many different classes of oncolytic virus. One of these, herpes oncolytic virus, is strongly oncolytic and has a large DNA genome as 150k bp. HF10 is a spontaneous mutant of herpes simplex virus -1 (HSV-1) that replicates within tumors and destroys cancers without damaging normal tissue and organs. Clinical trials of HF10 are underway in Japan and the United States...
May 2014: Hepato-gastroenterology
https://www.readbyqxmd.com/read/25377278/10-khz-high-frequency-scs-therapy-a-clinical-summary
#6
REVIEW
Marc Russo, Jean-Pierre Van Buyten
OBJECTIVE: Chronic pain remains a serious public health problem worldwide. A spinal cord stimulation (SCS) therapy called HF10 SCS uses 10-kHz high-frequency stimulation to provide pain relief without paresthesia. In this article, we describe the therapy, device, and the methods of implant and then review the safety and effectiveness data for this therapy. RESULTS: HF10 SCS uses a charge-balanced stimulation waveform that has been shown to be safe in both animal and human studies...
May 2015: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/25272216/cost-effectiveness-of-a-novel-10-khz-high-frequency-spinal-cord-stimulation-system-in-patients-with-failed-back-surgery-syndrome-fbss
#7
COMPARATIVE STUDY
Lieven Annemans, Jean-Pierre Van Buyten, Thomas Smith, Adnan Al-Kaisy
OBJECTIVES: Spinal cord stimulation (SCS) is an effective method of relieving chronic intractable pain, and one of its key indications is failed back surgery syndrome (FBSS). The objective of the current study was to evaluate the cost effectiveness of 10 kHz high-frequency SCS (HF10 SCS) compared to conventional medical management (CMM), reoperation, and traditional nonrechargeable (TNR-SCS) and rechargeable SCS (TR-SCS). METHODS: A health economic model of SCS in the United Kingdom was reproduced in the perspective of the health care system to simulate costs and quality adjusted life years (QALYs) over 15 years...
2014: Journal of Long-term Effects of Medical Implants
https://www.readbyqxmd.com/read/25156870/combination-therapy-of-oncolytic-herpes-simplex-virus-hf10-and-bevacizumab-against-experimental-model-of-human-breast-carcinoma-xenograft
#8
Gewen Tan, Hideki Kasuya, Tevfik Tolga Sahin, Kazuo Yamamura, Zhiwen Wu, Yusuke Koide, Yoshihiro Hotta, Toshio Shikano, Suguru Yamada, Akiyuki Kanzaki, Tsutomu Fujii, Hiroyuki Sugimoto, Shuji Nomoto, Yoko Nishikawa, Maki Tanaka, Naoko Tsurumaru, Toshie Kuwahara, Saori Fukuda, Toru Ichinose, Toyone Kikumori, Shin Takeda, Akimasa Nakao, Yasuhiro Kodera
Breast cancer is one of the most common and feared cancers faced by women. The prognosis of patients with advanced or recurrent breast cancer remains poor despite refinements in multimodality therapies involving chemotherapeutic and hormonal agents. Multimodal therapy with more specific and effective strategy is urgently needed. The oncolytic herpes simplex virus (HSV) has potential to become a new effective treatment option because of its broad host range and tumor selective viral distribution. Bevacizumab is a monoclonal antibody against VEGFA, which inhibits angiogenesis and therefore tumor growth...
April 1, 2015: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/24308759/sustained-effectiveness-of-10-khz-high-frequency-spinal-cord-stimulation-for-patients-with-chronic-low-back-pain-24-month-results-of-a-prospective-multicenter-study
#9
MULTICENTER STUDY
Adnan Al-Kaisy, Jean-Pierre Van Buyten, Iris Smet, Stefano Palmisani, David Pang, Thomas Smith
OBJECTIVE: The aim of this study was to investigate the long-term efficacy and safety of paresthesia-free high-frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic, intractable pain of the low back and legs. DESIGN: Prospective, multicenter, observational study. METHOD: Patients with significant chronic low back pain underwent implantation of a spinal cord stimulator capable of HF10 SCS. Patients' pain ratings, disability, sleep disturbances, opioid use, satisfaction, and adverse events were assessed for 24 months...
March 2014: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
https://www.readbyqxmd.com/read/24265099/oncolytic-viral-therapy-with-a-combination-of-hf10-a-herpes-simplex-virus-type-1-variant-and-granulocyte-macrophage-colony-stimulating-factor-for-murine-ovarian-cancer
#10
Fumi Goshima, Shinichi Esaki, Chenhong Luo, Maki Kamakura, Hiroshi Kimura, Yukihiro Nishiyama
Ovarian cancer is the most frequent cause of gynecological cancer-related mortality as a majority of patients are diagnosed at an advanced stage with intraperitoneal dissemination because of the absence of initial symptoms. Granulocyte-macrophage colony-stimulating factor (GM-CSF) plays an important role in the maturation of specialized antigen-presenting cells. In this study, we utilized a herpes simplex virus (HSV) amplicon expressing murine GM-CSF combined with HF10 (mGM-CSF amplicon), a highly attenuated HSV type 1 strain functioning as a helper virus to strengthen anti-tumor immune response, for the treatment of ovarian cancer with intraperitoneal dissemination...
June 15, 2014: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/24170435/combination-treatment-of-human-pancreatic-cancer-xenograft-models-with-the-epidermal-growth-factor-receptor-tyrosine-kinase-inhibitor-erlotinib-and-oncolytic-herpes-simplex-virus-hf10
#11
Kazuo Yamamura, Hideki Kasuya, Tevfik Tolga Sahin, Gewen Tan, Yoshihiro Hotta, Naoko Tsurumaru, Saori Fukuda, Mitsuro Kanda, Daisuke Kobayashi, Chie Tanaka, Suguru Yamada, Goro Nakayama, Tsutomu Fujii, Hiroyuki Sugimoto, Masahiko Koike, Shuji Nomoto, Michitaka Fujiwara, Maki Tanaka, Yasuhiro Kodera
BACKGROUND: There is the potential to use replication-competent oncolytic viruses to treat cancer. We evaluated the efficacy of HF10, a herpes simplex virus type 1 (HSV-1) mutant, in combination with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, in human pancreatic cancer xenograft models. METHODS: The viability of human pancreatic cancer cell lines (BxPC-3 and PANC-1) treated with HF10 and erlotinib, on their own or in combination, was determined...
February 2014: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/23887644/enhancement-of-systemic-tumor-immunity-for-squamous-cell-carcinoma-cells-by-an-oncolytic-herpes-simplex-virus
#12
N Meshii, G Takahashi, S Okunaga, M Hamada, S Iwai, A Takasu, Y Ogawa, Y Yura
RH2 is a neurovirulent γ134.5 gene-deficient herpes simplex virus type 1 (HSV-1) with a lytic ability in human squamous cell carcinoma (SCC) cells; it is related to spontaneously occurring HSV-1 mutant HF10. The effect of RH2 on SCC was examined using a syngeneic C3H mouse model. After infection of mouse SCCVII cells with RH2, cell viability was decreased at first, but recovered by prolonged culture, indicating the limited replication of RH2. The antitumor ability of RH2 was examined using a bilateral SCCVII tumor model...
September 2013: Cancer Gene Therapy
https://www.readbyqxmd.com/read/23852521/radiation-oxygen-biology-with-pulse-electron-paramagnetic-resonance-imaging-in-animal-tumors
#13
Gage Redler, Martyna Elas, Boris Epel, Eugene D Barth, Howard J Halpern
The reduced oxygen in tumors (hypoxia) generates radiation resistance and limits tumor control probability (TCP) at radiation doses without significant normal tissue complication. Modern radiation therapy delivery with intensity-modulated radiation therapy (IMRT) enables complex, high-dose gradient patterns, which avoid sensitive human tissues and organs. EPR oxygen images may allow selection of more resistant parts of a tumor to which to deliver more radiation dose to enhance TCP. EPR O2 images are obtained using injected narrow-line, low relaxation rate trityl spin probes that enable pulse radiofrequency EPR O2 images of tumors in the legs of mice, rats, and rabbits, the latter exceeding 4 cm in size...
2013: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/22949155/enhanced-antitumoral-activity-of-oncolytic-herpes-simplex-virus-with-gemcitabine-using-colorectal-tumor-models
#14
Shinichi Esaki, Fumi Goshima, Hiroshi Kimura, Shingo Murakami, Yukihiro Nishiyama
To enhance the oncolytic activity of herpes simplex viruses (HSVs) control of immune-suppression and immune-resistance by cancer cells is important. Myeloid-derived suppressor cells (MDSCs), which interfere with tumor-suppressive environments, are inhibited by gemcitabine (GEM) treatment. We investigated the oncolytic activity and systemic antitumor immunity induced by oncolytic HSVs in combination with GEM treatment. A mouse model with subcutaneous tumors on both sides of the lateral flanks was used. A highly attenuated HSV type 1, strain HF10, was inoculated into one side of each tumor three times following intraperitoneal injection of GEM...
April 1, 2013: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/22193629/impact-of-novel-oncolytic-virus-hf10-on-cellular-components-of-the-tumor-microenviroment-in-patients-with-recurrent-breast-cancer
#15
T T Sahin, H Kasuya, N Nomura, T Shikano, K Yamamura, T Gewen, A Kanzaki, T Fujii, T Sugae, T Imai, S Nomoto, S Takeda, H Sugimoto, T Kikumori, Y Kodera, Y Nishiyama, A Nakao
Oncolytic viruses are a promising method of cancer therapy, even for advanced malignancies. HF10, a spontaneously mutated herpes simplex type 1, is a potent oncolytic agent. The interaction of oncolytic herpes viruses with the tumor microenvironment has not been well characterized. We injected HF10 into tumors of patients with recurrent breast carcinoma, and sought to determine its effects on the tumor microenvironment. Six patients with recurrent breast cancer were recruited to the study. Tumors were divided into two groups: saline-injected (control) and HF10-injected (treatment)...
April 2012: Cancer Gene Therapy
https://www.readbyqxmd.com/read/21102422/a-phase-i-dose-escalation-clinical-trial-of-intraoperative-direct-intratumoral-injection-of-hf10-oncolytic-virus-in-non-resectable-patients-with-advanced-pancreatic-cancer
#16
A Nakao, H Kasuya, T T Sahin, N Nomura, A Kanzaki, M Misawa, T Shirota, S Yamada, T Fujii, H Sugimoto, T Shikano, S Nomoto, S Takeda, Y Kodera, Y Nishiyama
In 2005, we initiated a clinical trial that examined the efficacy of the oncolytic virus HF10 to treat pancreatic cancer. Pancreatic cancer continues to have a high mortality rate, despite multimodal treatments for patients, and new therapeutic methods are greatly needed. The current mainstream methods for cancer treatment include biological therapeutics such as trastuzumab (Herceptin) for breast cancer or erlotinib (Tarceva) for non-small cell lung cancer. Oncolytic virus therapy is a new and promising treatment strategy for cancer...
March 2011: Cancer Gene Therapy
https://www.readbyqxmd.com/read/20885447/carrier-cell-based-delivery-of-replication-competent-hsv-1-mutants-enhances-antitumor-effect-for-ovarian-cancer
#17
S Fujiwara, A Nawa, C Luo, M Kamakura, F Goshima, C Kondo, T Kiyono, F Kikkawa, Y Nishiyama
Oncolytic viruses capable of tumor-selective replication and cytolysis have shown early promise as cancer therapeutics. We have developed replication-competent attenuated herpes simplex virus type 1 (HSV-1) mutants, named HF10 and Hh101, which have been evaluated for their oncolytic activities. However, the host immune system remains a significant obstacle to effective intraperitoneal administration of these viruses in the clinical setting. In this study, we investigated the use of these HSV-1 mutants as oncolytic agents against ovarian cancer and the use of human peritoneal mesothelial cells (MCs) as carrier cells for intraperitoneal therapy...
February 2011: Cancer Gene Therapy
https://www.readbyqxmd.com/read/19604626/enhanced-cytotoxicity-with-a-novel-system-combining-the-paclitaxel-2-ethylcarbonate-prodrug-and-an-hsv-amplicon-with-an-attenuated-replication-competent-virus-hf10-as-a-helper-virus
#18
Daisuke Ishida, Akihiro Nawa, Tadatoshi Tanino, Fumi Goshima, Chen Hong Luo, Masahiro Iwaki, Hiroaki Kajiyama, Kiyosumi Shibata, Eiko Yamamoto, Kazuhiko Ino, Tatsuya Tsurumi, Yukihiro Nishiyama, Fumitaka Kikkawa
We previously demonstrated that HF10, which is a natural, non-engineered HSV-1, has potent oncolytic activity in the treatment of solid malignant tumors in vitro and in vivo [H. Takakuwa, F. Goshima, N. Nozawa, T. Yoshikawa, H. Kimata, A. Nakao, et al., Oncolytic viral therapy using a spontaneously generated herpes simplex virus type 1 variant for disseminated peritoneal tumor in immunocompetent mice, Arch. Virol. 148 (2003) 813-825; S. Kohno, C. Lou, F. Goshima, Y. Nishiyama, T. Sata, Y. Ono, Herpes simplex virus type 1 mutant HF10 oncolytic viral therapy for bladder cancer, Urology 66 (2005) 1116-1121; D...
February 1, 2010: Cancer Letters
https://www.readbyqxmd.com/read/18226503/oncolytic-virotherapy-for-malignant-melanoma-with-herpes-simplex-virus-type-1-mutant-hf10
#19
Daisuke Watanabe, Fumi Goshima, Isamu Mori, Yasuhiko Tamada, Yoshinari Matsumoto, Yukihiro Nishiyama
BACKGROUND: Many viruses have been engineered and evaluated for their potential as therapeutic agents in the treatment of malignant neoplasm, including malignant melanoma. OBJECTIVE: In this study, we investigated the efficacy of HF10, an attenuated, replication-competent HSV, in immunocompetent animal models with malignant melanoma. METHODS: For in vitro study, viral cytotoxicity assays and replication assays were performed both in human and mouse melanoma cells...
June 2008: Journal of Dermatological Science
https://www.readbyqxmd.com/read/17693992/oncolytic-virotherapy-with-an-hsv-amplicon-vector-expressing-granulocyte-macrophage-colony-stimulating-factor-using-the-replication-competent-hsv-type-1-mutant-hf10-as-a-helper-virus
#20
S-I Kohno, C Luo, A Nawa, Y Fujimoto, D Watanabe, F Goshima, T Tsurumi, Y Nishiyama
Direct viral infection of solid tumors can cause tumor cell death, but these techniques offer the opportunity to express exogenous factors to enhance the antitumor response. We investigated the antitumor effects of a herpes simplex virus (HSV) amplicon expressing mouse granulocyte-macrophage colony-stimulating factor (mGM-CSF) using the replication-competent HSV type 1 mutant HF10 as a helper virus. HF10-packaged mGM-CSF-expressing amplicon (mGM-CSF amplicon) was used to infect subcutaneously inoculated murine colorectal tumor cells (CT26 cells) and the antitumor effects were compared to tumors treated with only HF10...
November 2007: Cancer Gene Therapy
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