Clinical Trials: Nervous System Diseases

Influence of bladder management on long-term quality of life in patients with neurogenic lower urinary tract dysfunction Jürgen Pannek, Jörg Krebs, Jens Wöllner Asia Pacific Journal of Clinical Trials: Nervous System Diseases 2019 4(2):29-32 Background and objective: Patients with spinal cord injury suffer from neurogenic lower urinary tract dysfunction (NLUTD). NLUTD is associated with a considerable morbidity and mortality, but also affects the quality of life (QoL). We aimed to evaluate the longitudinal course of QoL in persons with NLUTD in relation to their bladder management. Subjects and methods: In a prospective self-controlled case series study. Patients with chronic NLUTD managing their bladder either by intermittent catheterization (n = 21), reflex voiding (n = 8), anterior root stimulation (n = 7), straining (n = 7) or suprapubic catheter (n = 4) were asked to fill in the Qualiveen® questionnaire at two time points with a time span of at least 1 year. Eleven patients were tetraplegic, and 36 persons suffered from paraplegia. The study was approved by the Ethics Committee of the Ethikkommission Nordwestund Zentralschweiz (approval No. PB_2016-02657) on September 24, 2007. Results: In total 47 patients returned both questionnaires and their data were therefore evaluated. The mean age at the first evaluation was 52 ± 12.8 years. The mean duration of NLUTD was 20.4 ± 12.3 years. A mean 2.4 ± 0.5 years had elapsed from the first to the second evaluation. None of the Qualiveen questionnaire domains showed a significant change between the two evaluation time points. The lesion level had a significant (P ≤ 0.023) effect on the domains constraints and QoL index. Conclusion: QoL in patients with chronic NLUTD seems to remain stable in long-term follow-up. Trial registration: ClinicalTrials.gov (NCT02179073) on July 1, 2014.

Efficacy of entacapone and pramipexole in treating non-motor symptoms of Parkinson's disease: a prospective randomized controlled trial Zheng Bei, Guo-Qiang Wen, Yi Chen, Ning Bei Asia Pacific Journal of Clinical Trials: Nervous System Diseases 2019 4(2):33-39 Background and objective: Individuals with Parkinson’s disease exhibit a variety of non-motor symptoms that can negatively impact quality of life. Although both entacapone and pramipexole can be used to treat Parkinson’s disease via modulation of dopamine metabolism, the ways in which these treatments differ in terms of their effects on the non-motor symptoms of Parkinson’s disease are unknown. Participants and methods: This prospective, randomized, controlled trial will be conducted in the Geriatric Hospital of Hainan, Haikou, China. A total of 388 patients with idiopathic Parkinson’s disease will be randomly assigned to receive entacapone (n = 194) or pramipexole (n = 194). This study was approved by the Ethics Committee of the Geriatric Hospital of Hainan, China on August 30, 2013 (approval number: S2013-038-01) on August 30, 2013. Written informed consent regarding the study protocol and surgical procedure will be obtained from all participants. Results: The primary outcome measure will be the rate of improvement of non-motor symptoms 3 weeks after treatment. Secondary outcome measures will be soluble interleukin-2 receptor and homocysteine levels in serum, which reflect inflammation, and adverse events before and 3 weeks after treatment. Our self-controlled pilot study involving 100 patients showed that incidences of autonomic neurological symptoms such as postural hypotension, urinary urgency, urinary frequency, sexual dysfunction, dry mouth, and salivation, psychiatric symptoms such as cognitive dysfunction, hallucination, depression, and anxiety, and sensory abnormalities such as spasm, pain, and restless leg syndrome were remarkably reduced. Meanwhile, levels of serum soluble interleukin-2 receptor and homocysteine had noticeably decreased after treatment with entacapone and pramipexole. Conclusion: This trial will confirm the efficacy of entacapone and pramipexole in the treatment of non-motor symptoms of Parkinson’s disease. We hope that our findings will provide direction for future clinical treatment of non-motor symptoms of Parkinson’s disease, leading to improved patient quality of life. Trial registration: This study was registered with the Chinese Clinical Trial Registry on April 15, 2019 (registration number: ChiCTR1900022534). Protocol version is 1.0.

Effect of transcranial direct current stimulation on the level of consciousness in patients with traumatic coma: study protocol for a self-controlled trial Nilpadma Sarkar, Subhasish Chatterjee, Ajay Gehlot Asia Pacific Journal of Clinical Trials: Nervous System Diseases 2019 4(2):40-43 Background and objectives: Traumatic brain injury patients suffer from coma, which leads to changes in behavior and consciousness. There is a paucity of available treatments which can improve the level of consciousness. Transcranial direct current stimulation (tDCS) is one of the non-invasive techniques to stimulate the motor cortex and improve the level of consciousness. The purpose of the study will be to assess the effect of tDCS on consciousness in patients with traumatic coma. Subjects and methods: The single-subject ABA design single-center study will be conducted in the Neuro-Surgery ICU, Maharishi Markandeshwar Hospital, India. Comatose patients associate with traumatic brain injury will be recruited. After baseline assessment all patients will get treatment with tDCS for 20 minutes twice a day for consecutive 5 days. Follow-up assessment will be taken on every first day of the consecutive 1st, 3rd and 5th weeks post-treatment. Ethical approval has been obtained from the Institutional Ethical Committee (IEC) of Maharishi Markandeshwar (Deemed to be University) (IEC/MMDU/2018/1183) on June 6, 2018. Outcome measures: JFK Coma Recovery Scale-Revised (CRS-R). Discussion: The study will investigate the possible effect of tDCS in improving level of consciousness in patients with traumatic brain injury. Trial registration: The study was registered with ctri.nic.in (CTRI/2019/01/017186) on January 22, 2019. It is the official website for registration of clinical trials in India regulated by Indian Council of Medical Research.

Efficacy and safety of traditional Chinese medicine combined with western medicine for early-phase treatment of acute ischemic stroke based on the primary syndrome elements: protocol for a randomized controlled trial Fu-Sheng Liu, Xiao-Lei Fang, Zhi-Rui Cheng, Jin Liu, Zhi Liu, Chen-Chen Sun, Lei Sun, Hui Jin Asia Pacific Journal of Clinical Trials: Nervous System Diseases 2019 4(2):44-50 Background and objective: Acute ischemic stroke is a major cause of disability among adults. Although traditional Chinese medicine and western medicine have been widely used for the treatment of acute ischemic stroke, their efficacy when used in combination for the treatment of acute ischemic stroke during the early phase is poorly understood. According to traditional Chinese medicine theory, the primary syndrome elements of acute ischemic stroke during the early stage include three pathogens, “wind,” “fire,” and “phlegm,” and treatments that target these primary syndrome elements contribute to recovery from the condition. We have designed a randomized controlled trial to investigate the efficacy and safety of traditional Chinese medicine combined with western medicine in the treatment of acute ischemic stroke during the early phase based on the primary syndrome elements. Subjects and methods: This prospective, single-center, assessor-blinded, randomized controlled trial will enroll 120 eligible patients with acute ischemic stroke who will receive treatment in the Department of Emergency, Dongfang Hospital of Beijing University of Chinese Medicine, China. Participants will be randomly assigned to a combined treatment group or a control group. Both groups will undergo treatment with conventional western medicine, and patients in the combined treatment group will also receive traditional Chinese medicine (i.e., oral stroke initial state decoction, intravenous Gastrodin injection, and Tanreqing injection; Xingnaojing injection will be added for patients who are unconscious). Immediately after admission, patients will undergo 3-day treatment for early-phase ischemic stroke and subsequently undergo a 2-week follow up. This study was approved by Hospital Ethics Committee, Dongfang Hospital, Beijing University of Traditional Medicine, China (approval No. JDF-IRB-2016033602) on November 2, 2016. Written informed consent will be obtained from conscious patients or the legal guardians of unconscious patients. Outcome measures: The primary outcome measures of this study are the National Institute of Health Stroke Scale score and traditional Chinese medicine stroke scale score on days 1, 3, 7, and 14 after treatment. Secondary outcome measures include National Institute of Health Stroke Scale score, Barthel index, Modified Rankin scale score, Glasgow coma scale score on days 1, 3, 7, and 14 after treatment, serum matrix metalloproteinase-9 and vascular endothelial growth factor levels on days 1 and 3 after treatment. Safety outcomes on days 1 and 3 after treatment and adverse events on days 3, 7, and 14 after treatment are also evaluated. Discussion: The results of this study will provide evidence to support the rationale for using traditional Chinese medicine combined with western medicine for the treatment of acute ischemic stroke during the early phase, and may indicate the underlying mechanism in this treatment strategy. Trial registration: This study was registered with the Chinese Clinical Trial Registration (registration number: ChiCTR-INR-16010075) on December 4, 2016. Study protocol refers to 1.0. Patient recruitment began in December 2016 and will be ended in November 2019.

Alexandros Sfakianakis
Anapafseos 5 . Agios Nikolaos
Crete.Greece.72100
2841026182

6948891480

alsfakia@gmail.com