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Acupuncture for gait disturbance of patients with subacute and chronic stroke: a systematic review and meta-analysis protocol
Introduction Hemiparetic gait is one of the most common sequelae of a stroke. Acupuncture has shown potential in correcting hemiplegic gait patterns and improving motor function recovery after stroke. However, controversial findings and a lack of supportive evidence on the effectiveness of acupuncture for post-stroke hemiplegia. The intelligent gait analysis system provides a new perspective for the study of hemiparetic gait. This systematic review aims to collect relevant studies and critically evaluate the efficacy and safety of acupuncture in alleviating gait disturbance of post-stroke hemiplegia based on quantified gai...
Source: BMJ Open - June 21, 2023 Category: General Medicine Authors: Sun, Z., Lin, Y.-r., Lu, M.-j., Huang, K.-y., Sun, K., Zhang, J.-b. Tags: Open access, Rehabilitation medicine Source Type: research

Carbon dioxide flooding to reduce postoperative neurological injury following surgery for acute type A aortic dissection: a prospective, randomised, blinded, controlled clinical trial, CARTA study protocol - objectives and design
This report describes the objectives and design of the CARTA trial, investigating whether carbon dioxide flooding reduces neurological injury following surgery for ATAAD. Methods and analysis The CARTA trial is a single-centre, prospective, randomised, blinded, controlled clinical trial of ATAAD surgery with carbon dioxide flooding of the surgical field. Eighty consecutive patients undergoing repair of ATAAD, and who do not have previous neurological injuries or ongoing neurological symptoms, will be randomised (1:1) to either receive carbon dioxide flooding of the surgical field or not. Routine repair will be performed r...
Source: BMJ Open - May 25, 2023 Category: General Medicine Authors: Ede, J., Teurneau-Hermansson, K., Moseby-Knappe, M., Ramgren, B., Bjursten, H., Ederoth, P., Larsson, M., Mattsson-Carlgren, N., Sjögren, J., Wierup, P., Nozohoor, S., Zindovic, I. Tags: Open access, Cardiovascular medicine Source Type: research

Multicentre registration of wake-up stroke in China (MCRWUSC): a protocol for a prospective, multicentre, registry-based cohort study
This study is approved by the ethics committee of Shanghai Pudong Hospital (Shanghai, China) and rest of all participating centres. The findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO registration number ChiCTR2100049133.
Source: BMJ Open - November 10, 2022 Category: General Medicine Authors: Zhang, Z., Yang, H., Tu, Z., Nepal, G., Ojha, R., Xi, Y., Qiao, J., Hu, M., Li, C., Lin, F., Zhou, L., Jin, P., Hou, S. Tags: Open access, Neurology Source Type: research

Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial
Introduction Stroke is the most common cause of neurological disability in adults worldwide. Neural stem cell (NSC) transplantation has shown promising results as a treatment for stroke in animal experiments. The pilot investigation of stem cells in stroke phase 1 and phase 2 trials showed that transplantation of the highest dose (20 million cells) was well tolerated. Preliminary clinical benefits have also been observed. However, the trials were open-label and had a small sample size. Furthermore, human NSCs (hNSCs) were intracerebrally implanted, and some serious adverse events were considered to be related to the surgic...
Source: BMJ Open - November 8, 2022 Category: General Medicine Authors: Xie, C., Wang, K., Peng, J., Jiang, X., Pan, S., Wang, L., Wu, Y., Guan, Y. Tags: Open access, Neurology Source Type: research

Association of cognitive reserve with stroke outcome: a protocol for a systematic review
Introduction The concept of cognitive reserve (CR) was introduced to account for individual differences in the clinical manifestation of neurodegenerative diseases. Though several mechanisms and risk factors are shared between neurodegeneration and stroke, the effect of CR on poststroke functional outcome has been poorly addressed. This systematic review aims to synthesise the available research evidence on the association of CR with stroke outcome, in order to implement the understanding of interindividual variability in stroke outcome and to improve its prediction. Methods and analysis Cochrane Library, Embase, PubMed, ...
Source: BMJ Open - July 8, 2022 Category: General Medicine Authors: Gallucci, L., Umarova, R. M. Tags: Open access, Neurology Source Type: research

Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR)
Introduction JTR-161 is a novel allogeneic human cell product consisting of dental pulp stem cells isolated from the extracted teeth of healthy adults. It is currently under development as a cell-based therapy for ischaemic stroke. The aim of this study is to evaluate the safety and efficacy of JTR-161 in patients with acute ischaemic stroke when given as a single intravenous administration within 48 hours of symptom onset. Methods and analysis This is a first-in-human, randomised, double-blind, placebo-controlled, multicentre, phase 1/2 clinical trial to be conducted in Japan (from January 2019 to July 2021). Patients wi...
Source: BMJ Open - May 24, 2022 Category: General Medicine Authors: Suda, S., Nito, C., Ihara, M., Iguchi, Y., Urabe, T., Matsumaru, Y., Sakai, N., Kimura, K., on behalf of the J- REPAIR trial group, Okubo, Takeuchi, Takao, Takahashi, Morimoto, Akaiwa, Ishii, Kanzawa, Kanai, Yoshimura, Hara, Tsujino, Kamatsuka, Inoue, Iwa Tags: Open access, Neurology Source Type: research

Statin and dual antiplatelet therapy for the prevention of early neurological deterioration and recurrent stroke in branch atheromatous disease: a protocol for a prospective single-arm study using a historical control for comparison
Introduction Branch atheromatous disease (BAD) contributes to small-vessel occlusion in cases of occlusion or stenosis of large calibre penetrating arteries, and it is associated with a higher possibility of early neurological deterioration (END) and recurrent stroke in acute ischaemic stroke. As the pathology of BAD is due to atherosclerosis, we postulate that early intensive medical treatment with dual antiplatelet therapy (DAPT) and high-intensity statins may prevent END and recurrent stroke in acute small subcortical infarction caused by BAD. Methods and analysis In this prospective, single-centre, open-label, non-ran...
Source: BMJ Open - November 26, 2021 Category: General Medicine Authors: Huang, Y.-C., Lee, J.-D., Weng, H.-H., Lin, L.-C., Tsai, Y.-H., Yang, J.-T. Tags: Open access, Neurology Source Type: research

Shunting outcomes in communicating hydrocephalus: protocol for a multicentre, open-label, randomised controlled trial
Introduction Ventriculoperitoneal shunt (VPS) remains the most widely used methods to treat communicating hydrocephalus. More recently, lumboperitoneal shunt (LPS) has been suggested as a reasonable option in some studies. However, there is lack of high-quality studies comparing these two techniques in order to certain the benefits and harms to use one of these two methods. The purpose of the current study is to determine the effectiveness and safety of the LPS versus the VPS in patients with communicating hydrocephalus. Methods and analysis All eligible patients aged 18–90 years with communicating hydrocephalus wil...
Source: BMJ Open - August 26, 2021 Category: General Medicine Authors: Sun, T., Cui, W., Yang, J., Yuan, Y., Li, X., Yu, H., Zhou, Y., You, C., Guan, J. Tags: Open access, Neurology Source Type: research

Identifying patients with cerebral infarction within the time window compatible with reperfusion therapy, diagnostic performance of glutathione S-transferase-{pi} (GST-{pi}) and peroxiredoxin 1 (PRDX1): exploratory prospective multicentre study FLAG-1 protocol
Introduction Plasma biomarkers may be useful in diagnosing acute cerebral infarction requiring urgent reperfusion, but their performance remains to be confirmed. If confirmed, these molecules could be used to develop rapid and reliable decentralised measurement methods, making it possible to initiate reperfusion therapy before hospital admission. The FLAG-1 large prospective study will constitute a plasma bank to assess the diagnostic performance of two biomarkers: glutathione S-transferase- and peroxiredoxin 1. These molecules are involved in the oxidative stress response and could identify cerebral infarction within a th...
Source: BMJ Open - August 20, 2021 Category: General Medicine Authors: Karakus, A., Girerd, N., Sanchez, J.-C., Sabben, C., Wietrich, A., Lavandier, K., Marchal, S., Aubertin, A., Humbertjean, L., Mione, G., Bouali, S., Duarte, K., Reymond, S., Gory, B., Richard, S. Tags: Open access, Neurology Source Type: research

Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol
Introduction Stroke is a serious public health problem, given it is a major cause of disability worldwide despite the spread of recanalisation therapies. Enhancement of brain plasticity with stem cell administration is a promising innovative therapy to reduce sequelae in these patients. Methods and analysis We have developed a phase IIb, multicentre, randomised, double-blind, placebo-controlled clinical trial protocol to evaluate the safety and efficacy of intravenous administration of allogeneic adipose tissue-derived mesenchymal stem cells (AD-MSCs) in patients with acute ischaemic stroke, concurrently with conventional...
Source: BMJ Open - August 9, 2021 Category: General Medicine Authors: de Celis-Ruiz, E., Fuentes, B., Moniche, F., Montaner, J., Borobia, A. M., Gutierrez-Fernandez, M., Diez-Tejedor, E. Tags: Open access, Neurology Source Type: research

The PROGRAM study: awake mapping versus asleep mapping versus no mapping for high-grade glioma resections: study protocol for an international multicenter prospective three-arm cohort study
This study is an international, multicenter, prospective three-arm cohort study of observational nature. Consecutive HGG patients will be operated with awake mapping, asleep mapping or no mapping with a 1:1:1 ratio. Primary endpoints are: (1) proportion of patients with National Institute of Health Stroke Scale deterioration at 6 weeks, 3 months and 6 months after surgery and (2) residual tumour volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: (1) overall survival and (2) progression-free survival at 12 months af...
Source: BMJ Open - July 21, 2021 Category: General Medicine Authors: Gerritsen, J. K. W., Dirven, C. M. F., De Vleeschouwer, S., Schucht, P., Jungk, C., Krieg, S. M., Nahed, B. V., Berger, M. S., Broekman, M. L. D., Vincent, A. J. P. E. Tags: Open access, Neurology Source Type: research

Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial
Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. Methods and analysis 360 participants...
Source: BMJ Open - December 4, 2014 Category: Journals (General) Authors: Fang, J., Chen, L., Chen, L., Wang, C., Keeler, C. L., Ma, R., Xu, S., Shen, L., Bao, Y., Ji, C. Tags: Open access, Complementary medicine Protocol Source Type: research