scholarly journals Effect of Specific Acupuncture Therapy Combined with Rehabilitation Training on Incomplete Spinal Cord Injury: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Feng Xiong ◽  
Jingkang Lu ◽  
Hongxia Pan ◽  
Fengyi Wang ◽  
Yaqin Huang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Acupuncture Therapy ◽  
Acupuncture Treatment ◽  
Control Group ◽  
Motor Score ◽  
Rehabilitation Training ◽  
Sensory Score ◽  
Cord Injury

Acupuncture therapies were used to treat spinal cord injury (SCI) and its complications. To assess the effect of a specific acupuncture therapy combined with rehabilitation training for inpatients with incomplete SCI, we conducted an assessor-blinded, randomized controlled clinical trial in the Department of Rehabilitation Medicine Center in West China Hospital, Sichuan University. Seventy-two participants diagnosed with incomplete SCI were randomly assigned into 3 groups of 24 patients each, with data collection completed in December, 2019. Participants were randomly assigned (1 : 1 : 1) to 3 groups to receive treatment for 4 weeks, 5 times/week of acupuncture for Continuous Acupuncture Treatment (CAT) group, 3 times/week for Intermittent Acupuncture Treatment (IAT) group, and no acupuncture for Control group; all 3 groups received routine rehabilitation training. The primary outcome was the change of American Spinal Injury Association (ASIA) motor score from baseline to week 4. Secondary outcomes included sensory score, Modified Barthel Index (MBI). At week 4, CAT group had a higher motor score and MBI score increase than the control group (mean difference 10.52, 17.36; p  < 0.001, p  < 0.01, respectively). CAT group had more increase in motor score and MBI than IAT group (mean difference 5.55, 14.77; p  < 0.05, p  < 0.05, respectively). But the difference among groups in the increase of sensory score was not statistically significant. Acupuncture resulted in a higher motor score and MBI after 4 weeks. And the dosage of 5/week led to more improvement in motor score and MBI than that of 3/week. The results suggested that a dosage of 5/week of acupuncture is safe and more effective for SCI than 3/week. But further research is needed to determine the best intervention dosage, long-term efficacy, and underlying mechanism. This trial is registered with ChiCTR1900021530.

scholarly journals Clinical Trial of Human Fetal Brain-Derived Neural Stem/Progenitor Cell Transplantation in Patients with Traumatic Cervical Spinal Cord Injury

2015 ◽  
Vol 2015 ◽  
pp. 1-22 ◽  
Author(s):  
Ji Cheol Shin ◽  
Keung Nyun Kim ◽  
Jeehyun Yoo ◽  
Il-Sun Kim ◽  
Seokhwan Yun ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Cell Transplantation ◽  
Cervical Spinal Cord ◽  
Fetal Brain ◽  
Tumor Formation ◽  
Cervical Spinal Cord Injury ◽  
Control Group ◽  
Cord Injury

In a phase I/IIa open-label and nonrandomized controlled clinical trial, we sought to assess the safety and neurological effects of human neural stem/progenitor cells (hNSPCs) transplanted into the injured cord after traumatic cervical spinal cord injury (SCI). Of 19 treated subjects, 17 were sensorimotor complete and 2 were motor complete and sensory incomplete. hNSPCs derived from the fetal telencephalon were grown as neurospheres and transplanted into the cord. In the control group, who did not receive cell implantation but were otherwise closely matched with the transplantation group, 15 patients with traumatic cervical SCI were included. At 1 year after cell transplantation, there was no evidence of cord damage, syrinx or tumor formation, neurological deterioration, and exacerbating neuropathic pain or spasticity. The American Spinal Injury Association Impairment Scale (AIS) grade improved in 5 of 19 transplanted patients, 2 (A → C), 1 (A → B), and 2 (B → D), whereas only one patient in the control group showed improvement (A → B). Improvements included increased motor scores, recovery of motor levels, and responses to electrophysiological studies in the transplantation group. Therefore, the transplantation of hNSPCs into cervical SCI is safe and well-tolerated and is of modest neurological benefit up to 1 year after transplants. This trial is registered with Clinical Research Information Service (CRIS), Registration Number:KCT0000879.

scholarly journals Effects of Atorvastatin in Patients with Acute Spinal Cord Injury

2017 ◽  
Vol 11 (6) ◽  
pp. 903-907 ◽  
Author(s):  
Javad Aghazadeh ◽  
Parviz Samadi Motlagh ◽  
Firooz Salehpour ◽  
Ali Meshkini ◽  
Majid Fatehi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Surgical Therapy ◽  
Acute Spinal Cord Injury ◽  
Control Group ◽  
Case Group ◽  
Significant Difference ◽  
Cord Injury

<sec><title>Study Design</title><p>Clinical trial study.</p></sec><sec><title>Purpose</title><p>The aim of this study was to evaluate the effect of atorvastatin on sensory and motor function in patients with acute spinal cord injury.</p></sec><sec><title>Overview of Literature</title><p>The prevalence and incidence of traumatic spinal cord injury are increasing. Statins are well established for use in hypercholesterolemia as well as during anti-inflammatory events.</p></sec><sec><title>Methods</title><p>This clinical trial study included 60 patients with acute spinal cord injury. These were randomly divided into two groups: the case group which received atorvastatin and also underwent surgical therapy and the control group which only underwent surgical therapy.</p></sec><sec><title>Results</title><p>The severity of spinal cord lesions was evaluated based on the Frankel grade at three periods; this showed no significant difference between the two groups. Comparisons of the levels of pain between the groups based on a Visual Analog Scale system showed no significant difference at the three periods.</p></sec><sec><title>Conclusions</title><p>We observed no improvement at the 3- and 6-month follow-up in patients who were administered atorvastatin. However, a comparison of the two groups based on pain severity demonstrated a significant difference, suggesting that atorvastatin had a positive effect on patients with spinal cord injury.</p></sec>

scholarly journals Granulocyte-colony stimulating factor administration for neurological improvement in patients with postrehabilitation chronic incomplete traumatic spinal cord injuries: a double-blind randomized controlled clinical trial

2018 ◽  
Vol 29 (1) ◽  
pp. 97-107 ◽  
Author(s):  
Nazi Derakhshanrad ◽  
Hooshang Saberi ◽  
Mir Saeed Yekaninejad ◽  
Mohammad Taghi Joghataei ◽  
Abdolreza Sheikhrezaei
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Placebo Group ◽  
Spinal Cord Injuries ◽  
Functional Improvement ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Cord Injury

OBJECTIVEGranulocyte-colony stimulating factor (G-CSF) is a major growth factor for activation and differentiation of granulocyte colonies in the bone marrow. This cytokine has been widely and safely employed in different conditions over many years. The purpose of this study was to investigate the efficacy of G-CSF administration for traumatic spinal cord injury (TSCI).METHODSThis double-blind parallel randomized, placebo-controlled, clinical trial, a phase III study, was performed from June 2013 to June 2016 in the Brain and Spinal Cord Injury Research (BASIR) center at Tehran University of Medical Sciences (TUMS). It included 120 patients with incomplete chronic TSCI, American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C, or D, of at least 6 months’ duration. Sixty patients were allocated into the treatment group and 60 patients into the control group. All the patients had completed an outpatient rehabilitation program in the postacute period and were in a neurological and functional plateau. Patients were assessed with the ASIA grading system, the Spinal Cord Independence Measure (SCIM-III), and the International Association of Neurorestoratology-Spinal Cord Injury Functional Rating Scale (IANR-SCIFRS) just before intervention and at 1, 3, and 6 months after 7 subcutaneous administrations of 300 μg/day of G-CSF in the treatment group and placebo in the control group (administered once per day over the course of 1 week). Randomization was performed with randomized block design, and the patients and evaluators were blinded regarding the treatment groups. One patient did not receive the entire allocated intervention and 5 patients were lost to follow-up. Thus data from 114 patients were included in the analysis.RESULTSOne hundred twenty patients were randomized and allocated into the study groups. Among them, 56 patients (93.3%) in the G-CSF group and 58 patients (96.6%) in the placebo group completed the study protocol. After 6 months of follow-up, AIS in the placebo group remained unchanged, whereas in the G-CSF group, 1 patient improved from AIS B to C, and 4 patients improved from AIS C to D. The mean (± SE) improvement in ASIA motor score in the G-CSF group was 5.5 ± 0.62, which was significantly more than in the placebo group (0.77 ± 0.20) (p < 0.001). The mean light touch and pinprick sensory scores, respectively, increased by 6.1 ± 1.1 and 8.7 ± 1.5 in the G-CSF group and by 1.3 ± 0.52 and 0.89 ± 0.44 scores in the placebo group (p < 0.001). Evaluation of functional improvement by the IANR-SCIFRS instrument revealed significantly more improvement in the G-CSF group (3.5 ± 0.37) than in the placebo group (0.41 ± 0.12) (p < 0.001). Also, a significant difference was observed in functional improvement between the 2 groups as measured by SCIM-III instrument (7.5 ± 0.95 vs 2.1 ± 0.51, p < 0.001).CONCLUSIONSAdministration of G-CSF for incomplete chronic spinal cord injuries is associated with significant motor, sensory, and functional improvement.Clinical trial registration no.: IRCT201108297441N1 (www.irct.ir)

scholarly journals Exercise Ameliorates Spinal Cord Injury by Changing DNA Methylation

Cells ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 143
Author(s):  
Ganchimeg Davaa ◽  
Jin Young Hong ◽  
Tae Uk Kim ◽  
Seong Jae Lee ◽  
Seo Young Kim ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Motor Cortex ◽  
Functional Recovery ◽  
Treadmill Exercise ◽  
Exercise Group ◽  
Control Group ◽  
Epigenetic Changes ◽  
Cord Injury ◽  
The Brain

Exercise training is a traditional method to maximize remaining function in patients with spinal cord injury (SCI), but the exact mechanism by which exercise promotes recovery after SCI has not been identified; whether exercise truly has a beneficial effect on SCI also remains unclear. Previously, we showed that epigenetic changes in the brain motor cortex occur after SCI and that a treatment leading to epigenetic modulation effectively promotes functional recovery after SCI. We aimed to determine how exercise induces functional improvement in rats subjected to SCI and whether epigenetic changes are engaged in the effects of exercise. A spinal cord contusion model was established in rats, which were then subjected to treadmill exercise for 12 weeks. We found that the size of the lesion cavity and the number of macrophages were decreased more in the exercise group than in the control group after 12 weeks of injury. Immunofluorescence and DNA dot blot analysis revealed that levels of 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) in the brain motor cortex were increased after exercise. Accordingly, the expression of ten-eleven translocation (Tet) family members (Tet1, Tet2, and Tet3) in the brain motor cortex also elevated. However, no macrophage polarization was induced by exercise. Locomotor function, including Basso, Beattie, and Bresnahan (BBB) and ladder scores, also improved in the exercise group compared to the control group. We concluded that treadmill exercise facilitates functional recovery in rats with SCI, and mechanistically epigenetic changes in the brain motor cortex may contribute to exercise-induced improvements.

scholarly journals AAV2-mediated and hypoxia response element-directed expression of bFGF in neural stem cells showed therapeutic effects on spinal cord injury in rats

2021 ◽  
Vol 12 (3) ◽  
Author(s):  
Sipin Zhu ◽  
Yibo Ying ◽  
Jiahui Ye ◽  
Min Chen ◽  
Qiuji Wu ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Control Group ◽  
Therapeutic Effects ◽  
Hypoxia Response Element ◽  
Neurofilament Protein ◽  
Response Element ◽  
Hypoxia Response ◽  
Cord Injury

AbstractNeural stem cell (NSCs) transplantation has been one of the hot topics in the repair of spinal cord injury (SCI). Fibroblast growth factor (FGF) is considered a promising nerve injury therapy after SCI. However, owing to a hostile hypoxia condition in SCI, there remains a challenging issue in implementing these tactics to repair SCI. In this report, we used adeno-associated virus 2 (AAV2), a prototype AAV used in clinical trials for human neuron disorders, basic FGF (bFGF) gene under the regulation of hypoxia response element (HRE) was constructed and transduced into NSCs to yield AAV2-5HRE-bFGF-NSCs. Our results showed that its treatment yielded temporally increased expression of bFGF in SCI, and improved scores of functional recovery after SCI compared to vehicle control (AAV2-5HRE-NSCs) based on the analyses of the inclined plane test, Basso–Beattie–Bresnahan (BBB) scale and footprint analysis. Mechanistic studies showed that AAV2-5HRE-bFGF-NSCs treatment increased the expression of neuron-specific neuronal nuclei protein (NeuN), neuromodulin GAP43, and neurofilament protein NF200 while decreased the expression of glial fibrillary acidic protein (GFAP) as compared to the control group. Further, the expressions of autophagy-associated proteins LC3-II and Beclin 1 were decreased, whereas the expression of P62 protein was increased in AAV2-5HRE-bFGF-NSCs treatment group. Taken together, our data indicate that AAV2-5HRE-bFGF-NSCs treatment improved the recovery of SCI rats, which is accompanied by evidence of nerve regeneration, and inhibition of SCI-induced glial scar formation and cell autophagy. Thus, this study represents a step forward towards the potential use of AAV2-5HRE-bFGF-NSCs for future clinical trials of SCI repair.

scholarly journals Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study

Spinal Cord ◽  
2021 ◽  
Author(s):  
Helge Kasch ◽  
Uffe Schou Løve ◽  
Anette Bach Jønsson ◽  
Kaare Eg Severinsen ◽  
Marc Possover ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Control Group ◽  
Walking Ability ◽  
Data Set ◽  
Cord Injury

Abstract Study design 1-year prospective RCT. Objective Examine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI. Methods Inclusion criteria: traumatic spinal cord injury (SCI), age 18–55 years, neurological level-of-injury Th4–L1, time-since-injury >1 year, and AIS-grades A–B. Participants were randomized to (A) LION procedure or (B) control group receiving NMES. Primary outcome measure: Walking Index for Spinal Cord Injury (WISCI-II), which is a SCI specific outcome measure assessing ability to ambulate. Secondary outcome measures: Spinal Cord Independence Measure III (SCIM III), Patient Global Impression of Change (PGIC), Penn Spasm Frequency Scale (PSFS), severity of spasticity measured by Numeric Rating Scale (NRS-11); International Spinal Cord Injury data sets-Quality of Life Basic Data Set (QoLBDS), and Brief Pain Inventory (BPI). Results Seventeen SCI individuals, AIS grade A, neurological level ranging from Th4–L1, were randomized to the study. One individual was excluded prior to intervention. Eight participants (7 males) with a mean age (SD) of 35.5 (12.4) years were allocated to the LION procedure, 8 participants (7 males) with age of 38.8 (15.1) years were allocated to NMES. Significantly, 5 LION group participants gained 1 point on the WISCI II scale, (p < 0.013; Fisher´s exact test). WISCI II scale score did not change in controls. No significant changes were observed in the secondary outcome measures. Conclusion The LION procedure is a promising new treatment for individuals with SCI with significant one-year improvement in walking ability.

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