Background and objectives: Cerebral palsy is the most common cause of dyskinesia in children and is not curable by generalized rehabilitation, pharmacotherapy, Chinese medicine, exercise therapy, or surgery. To date, several case reports have demonstrated that umbilical cord mesenchymal stem cells (UCMSCs)/neural stem cells (NSCs) have a therapeutic role in children with cerebral palsy; however, there has been no large-sample clinical trial to verify this. Therefore, there is a need to evaluate the safety and effectiveness of UCMSCs/NSCs for the treatment of cerebral palsy in children. Design: A prospective randomized parallel-controlled trial. Methods: One hundred and ten children with cerebral palsy who will receive treatment in the First Affiliated Hospital of Dalian Medical University, China, will be randomly divided into five groups (n = 22 per group): control, nasal transplantation of UCMSCs, lumbar puncture transplantation of UCMSCs, nasal transplantation of NSCs, and lumbar puncture transplantation of NSCs. Cell transplantation will be correspondingly conducted in the latter four groups, with at least 1 × 10⁷ cells per session, for two sessions within 4 weeks as one course, for a total of two courses. Outcome measures: Evaluations will be performed before cell treatment and at 1, 3, 6, 9, and 12 months after the completion of two treatment courses, including Gross Motor Function Measure (GMFM)-88, GMFM-66, Fine Motor Function Measure (FMFM), Modified Ashworth Scale, the Gesell Developmental Schedules, electroencephalogram examination and brain imaging examination. The primary outcome of this study is the overall objective response rate calculated on the basis of the changes in GMFM-88 total score and GMFM-66 reference percentile. The secondary outcomes of this study include the duration of response and progression-free survival based on the GMFM-88 total score change and GMFM-66 percentile change as well as overall survival, FMFM score, Modified Ashworth Scale score, the Gesell Developmental Schedules score, electroencephalogram examination and brain imaging examination. Discussion: This study aims to verify the efficacy and safety of UCMSCs/NSCs transplantation for the treatment of cerebral palsy in children, providing experimental data to support UCMSCs/NSCs therapy for cerebral palsy in clinical practice. Ethics and dissemination: Written informed consent will be given by legal guardians or authorized surrogates of children with cerebral palsy as well as donors or their legal guardians. Design of the trial was completed in November 2016, and registered with ClinicalTrials.gov in December 2016. Participant recruitment was initialized in March 2017, and is expected to last 2 years. Data collection and follow-up visit will end in June 2020, and data analysis will be completed in December 2020. The results of this study will be disseminated by publications in peer-reviewed journals. Trial registration: This trial was registered in the ClinicalTrials.gov with registration No. NCT03005249 on December 26, 2016.

Background and objectives: Senile degenerative lumbar spinal stenosis typically manifests clinically as lower back and leg pain caused by compression of the nerve root. Conventional total laminectomy for degenerative lumbar spinal stenosis can quickly alleviate a patient's symptoms, but produces an unsatisfactory therapeutic effect because of spinal instability caused by degenerative spondylolisthesis, and also has many adverse reactions. The purpose of this study is to investigate whether total laminectomy combined with lumbar pedicle screw fixation for treatment of senile degenerative lumbar spinal stenosis can effectively reduce lower back and leg pain caused by compression of the nerve root, increase lumbar spine stability, and reduce adverse reactions. Design: A prospective, single-center, self-control, interventional trial. Methods: One hundred and sixty older adult patients with degenerative lumbar spinal stenosis who will receive treatment at the Department of Orthopedics, Qinghai Provincial People's Hospital, China will be included in this study. All patients will undergo total laminectomy combined with lumbar pedicle screw fixation, with follow-up at 3, 6, 9, and 12 months post-surgery. Outcome measures and preliminary results: The primary outcome measure of this study is recovery rate in Japanese Orthopedic Society (JOA) score at 12 months post-surgery, which is used to evaluate improvements in patients lower back and leg pain. Secondary outcome measures of this study include changes in JOA score, spinal canal diameter, lumbar spine morphology displayed on computed tomography images, and incidence of adverse events post-surgery. Results of a preliminary study involving 71 older adult patients with degenerative lumbar spinal stenosis who received the same treatment showed that at 3 months post-surgery, JOA score and spinal canal diameter were significantly increased compared with before surgery (P < 0.05). Discussion: Findings from this study may provide clinical evidence supporting that total laminectomy combined with lumbar pedicle screw fixation is a safe and reliable method for treatment of senile degenerative lumbar spinal stenosis because it rapidly alleviates lower back and leg pain and provides spine stability. Ethics and dissemination: This study was approved by Medical Ethics Committee of Qinghai Provincial People's Hospital of China (approval No. QHY201602G). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in August 2018. Data analysis will be performed in October 2019. The study will be completed in December 2019. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Protocol version: 1.0. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800014726).

Background and objectives: Controlling the urge to smoke that stems from a cue-induced craving is the key to successfully breaking the habit. Transcranial direct current stimulation (tDCS) has been shown to improve human control over cognition and behavior. Preliminary behavioral studies have shown that tDCS can reduce cigarette cravings. However, the underlying neural mechanism remains poorly understood. In this study, we used transcranial direct current to stimulate the dorsolateral prefrontal cortex in patients who were addicted to cigarettes. We analyzed the correlation between changes in brain function indicators (e.g., local brain activation and long-distance connectivity) caused by tDCS and the change in cigarette cravings, with the purpose of identifying the neural mechanism by which tDCS to the prefrontal lobe reduces cigarette cravings. Design: A prospective, single-center, randomized, controlled crossover trial. Methods: Forty-two patients addicted to cigarettes who received treatment in the Affiliated Hospital of Anhui Medical University, China received one session each of real and sham tDCS. The time interval between real and sham stimulations was 1 week. The order of stimulation was determined using a random number table. For real tDCS, stimulation intensity was 1 mA, and stimulation time was 30 minutes. For sham tDCS, stimulation intensity was increased to 1 mA within 30 seconds, and then decreased to 0 mA within the next 30 seconds. Stimulation was not performed within the subsequent 29 minutes. At the end of each stimulation session, functional magnetic resonance imaging was performed to record brain activity in patients during a smoking-cue task. Participants reported how much they craved cigarettes using a Visual Analog Scale before and after watching smoking scenes. Outcome measures and results: The primary outcome measure was the degree to which cigarette cravings increased after watching smoking scenes following each stimulation session. The secondary outcome measures were local brain activation and long-distance connectivity between activated brain regions after watching smoking scenes, as well as the incidence of reverse reactions following each stimulation session. After the data collection was complete, data from 32 of the 42 initial patients were included in the final analysis. The results revealed that the increase in cue-induced cigarette cravings was significantly reduced (t = 2.319, df = 31, P = 0.027) after real tDCS compared to sham tDCS. Significant effects were observed in the left superior frontal gyrus and left middle frontal gyrus. Psychophysiological interaction revealed that the connectivity between the dorsolateral prefrontal cortex and the right parahippocampal gyrus was correlated with the amount of increase in cue-induced cigarette cravings (r = 0.522, P = 0.002). Discussion: Based on fMRI findings, the present study was performed to identify the neural mechanism through which tDCS reduces cue-induced cigarette craving. Preliminary results suggest that electrical stimulation to the dorsolateral prefrontal cortex reduces craving by modulating the long-distance coupling associated with the dorsolateral prefrontal cortex. Ethics and dissemination: This study was approved by the Biomedical Ethics Committee, Anhui Medical University, China (approval number: 20140241). The study protocol was performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent of the study protocol and procedure was obtained from each patient. Patient recruitment and data collection began in March 2014. Outcome measures were analyzed in February 2015. The trial ended in March 2015. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-16007980).

Background and objectives: Patients with treatment-resistant depression (TRD) show no improvement after treatment with a series of drugs. Previous reports have described positive effects of vagus nerve stimulation (VNS) on the emotional states of patients with epilepsy. VNS for TRD has not been explored in China. We will investigate the efficacy and safety of VNS for the treatment of TRD in a Chinese cohort. Design: A pilot self-controlled trial. Methods: The study population will comprise 10 consecutive patients with TRD admitted to Beijing Anding Hospital at Capital Medical University in Beijing, China. The patients will receive routine treatment supplemented with VNS starting at 2 weeks after surgery. Follow-up evaluations will be performed at 1, 2, 3, 6, and 12 months of nerve stimulation. Outcome measures: The primary outcome measure will be the change in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to 12 months of nerve stimulation. The secondary outcome measures will include the proportion of patients who achieve ≥ 50% reduction from baseline in the HAMD-17 total score, complete remission rate, and the Quick Inventory of Depression Symptomatology-Self Report, 7-item Generalized Anxiety Disorder Scale, Global Assessment of Function, Clinical Global Impression-severity, Clinical Global Impression-improvement, Hamilton Rating Scale for Anxiety, Young Mania Rating Scale, Patient Health Questionaire-15, Sheehan Disability Scale, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Perceived Deficits Questionnaire-Depression, Frequency, Intensity and Burden of Side Effects Rating, and Columbia-Suicide Severity Rating Scale scores. Discussion: The trial will provide objective data on the potential of the clinical implementation of VNS as a treatment for TRD in China. Ethics and dissemination: This study protocol was approved by the Institution Review Board of Beijing Anding Hospital of Capital Medical University in China (approval No. 201775FS-2) at October 2017. Design of the study was finished in August 2017, participant recruitment was started at December 2017, and data analysis will be completed until December 2021. The results of the study will be disseminated through presentations at peer-reviewed publications. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR-ONC-174013430 (version 2.0) in November 2017.