scholarly journals M245. AN RCT PROTOCOL OF HYBRID-ECT FOR SCHIZOPHRENIA

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S229-S229
Author(s):  
Han Rong
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Remission Rate ◽  
Auditory Hallucination ◽  
Pilot Trial ◽  
Primary Outcome Measure ◽  
Seizure Threshold ◽  
Secondary Outcome ◽  
Control Group ◽  
Initial Sessions

Abstract Background Electroconvulsive therapy (ECT) is an rapid and effective treatment for schizophrenia patients, ECT may achieve significant antipsychotic effects in the several initial sessions, but significant side effects limit its use. However, our low-charge electrotherapy (LCE) pilot trial demonstrated antipsychotic effects with significantly fewer side effects. The aim of this trial is to propose a novel two-step charge set strategy for ECT treatment, referred to as Hybrid-ECT, try to decrease side effects by using a lower charge while preserving treatment efficacy. Methods A randomized, double-blinded, standard-controlled, parallel-group design will be used. We plan to enroll 62 inpatients diagnosed with acute schizophrenia and randomly assign them to routine ECT (control group) or to Hybrid-ECT (treatment group, 3 ECT sessions followed by LCE sessions (approximately half of seizure threshold per session)). The primary outcome measure is the change in total PANSS score after the last ECT/LCE session. The secondary outcome measures include the response rate, remission rate, CGI, auditory hallucination rating scale, and everyday memory questionnaire (EMQ) scales. Neuropsychological metrics include the repeatable battery for the assessments of neuropsychological status (RBANS) and the stroop test, and detailed side effects will be evaluated. Structure and functional magnetic resonance imaging (MRI) assessments during treatment will be performed to explore brain changes between ECT and hybrid-ECT groups. The follow-up phase is set at the one-month after the last ECT/LCE session Results No results. Discussion This research will propose a simple but completely novel ECT strategy that aims to rapidly relieve psychosis symptoms and minimize side effects. If Hybrid-ECT is found to have the potentiality mentioned above, this could have important implications for future ECT strategies in treating schizophrenia patients in the acute phase. In addition, by using the detailed neuropsychological assessments and MRI scanning, this study may improve the knowledge of ECT-related antipsychotic mechanisms.

scholarly journals The effects of a novel pilates exercise prescription method on people with non-specific unilateral musculoskeletal pain: a randomised pilot trial

2016 ◽  
Vol 25 (4) ◽  
pp. 201-206
Author(s):  
Augustine Joshua Devasahayam ◽  
Doreen Ren Yan Ho ◽  
Elsa Yee Sum Leung ◽  
Ming Rong Goh ◽  
Patricia Koh
Keyword(s):  
Musculoskeletal Pain ◽  
Rating Scale ◽  
Exercise Prescription ◽  
Numerical Rating Scale ◽  
Pilot Trial ◽  
Neuromuscular Control ◽  
Secondary Outcome ◽  
Patient Specific ◽  
Control Group ◽  
Numerical Rating

Background: Pain alters the neuromuscular activation and results in altered movement adaptations. A new exercise prescription method proposes that we can restore the neuromuscular control by rehabilitating the deficient neural drive through Pilates exercises. This is done by identifying the postural control deficits using single-leg tests such as hopping, half squats and heel raises. The aim of this study was to find out if this method of prescribing exercises results in clinically relevant outcomes. Methods: Fifteen patients with chronic non-specific low back pain with unilateral musculoskeletal pain were recruited. Following consent, all patients were randomly assigned either to perform gym or Pilates-based individualised exercises once weekly for six weeks. The primary outcome was to measure the pain intensity using a 0–10 numerical rating scale. The secondary outcome measures were: the global perceived effect scale (GPE; 0–10), the patient-specific functional scale (PSFS; the patient-generated measure of disability) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; the condition-specific measure of disability). Results: There were statistically significant differences noted after intervention within the control group in the numerical rating scale ( P=0.041), GPE ( P=0.024), PSFS ( P=0.039) and within the experimental group in the WOMAC ( P=0.008), GPE ( P=0.007) and PSFS ( P=0.007). However, as there were clinically significant baseline differences, the within-group difference could be due to regression to the mean. There were no statistically significant results between the two groups after intervention. Conclusion: This new prescription method for Pilates-based exercises may improve disability and global perception of recovery. However, the outcomes are not different from a regular gym-based exercise programme.

scholarly journals Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Hsien-Yin Liao ◽  
Wen-Chao Ho ◽  
Chun-Chung Chen ◽  
Jaung-Geng Lin ◽  
Chia-chi Chang ◽  
...  
Keyword(s):  
Rating Scale ◽  
Primary Outcome Measure ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Psychological Improvement ◽  
To Receive

Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it.Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI), Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS) for pain scores.Results. Of the 52 patients who were randomized to receive acupuncture (n=28) or placebo (n=24), 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (pvalue = 0.04). There were no significant differences in the other measures between the two groups.Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Anterior Circulation ◽  
Guide Catheter ◽  
Catheter Failure ◽  
Catheter Technology ◽  
Intracranial Vasculature

BackgroundMost conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation.MethodsThis is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement.ResultsEach study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0–2%, and 10.26% were deceased.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

scholarly journals Donepezil for mild cognitive impairment in Parkinson’s disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kyoungwon Baik ◽  
Seon Myeong Kim ◽  
Jin Ho Jung ◽  
Yang Hyun Lee ◽  
Seok Jong Chung ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Treatment Group ◽  
Outcome Measures ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Significant Difference

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

scholarly journals Functional endoscopy in neurogenic dysphagia: a feasibility study focusing on the esophageal phase of swallowing

2021 ◽  
Vol 09 (04) ◽  
pp. E646-E652
Author(s):  
Jan Rückert ◽  
Philipp Lenz ◽  
Hauke Heinzow ◽  
Johannes Wessling ◽  
Tobias Warnecke ◽  
...  
Keyword(s):  
Primary Outcome Measure ◽  
Interdisciplinary Cooperation ◽  
Upper Esophageal Sphincter ◽  
Secondary Outcome ◽  
Diagnostic Tools ◽  
Control Group ◽  
Special Focus ◽  
Neurogenic Dysphagia ◽  
High Resolution Manometry ◽  
Multidisciplinary Study

Abstract Background and study aims Due to demographic transition, neurogenic dysphagia has become an increasingly recognized problem. Patients suffering from dysphagia often get caught between different clinical disciplines. In this study, we implemented a defined examination protocol for evaluating the whole swallowing process by functional endoscopy. Special focus was put on the esophageal phase of swallowing. Patients and methods This prospective observational multidisciplinary study evaluated 31 consecutive patients with suspected neurogenic dysphagia by transnasal access applying an ultrathin video endoscope. Thirty-one patients with gastroesophageal reflux symptoms were used as a control group. We applied a modified approach including standardized endoscopic positions to compare our findings with fiberoptic endoscopic evaluation of swallowing and high-resolution manometry. The primary outcome measure was feasibility of functional endoscopy. Secondary outcome measures were adverse events (AEs), tolerability, and pathologic endoscopic findings. Results Functional endoscopy was successfully performed in all patients. No AEs were recorded. A variety of disorders were documented by functional endoscopy: incomplete or delayed closure of the upper esophageal sphincter in retroflex view, clearance disturbance of tubular esophagus, esophageal hyperperistalsis, and hypomotility. Analysis of results obtained with the diagnostic tools showed some discrepancies. Conclusions By interdisciplinary cooperation with additional assessment of the esophageal phase of deglutition using the innovative method of functional endoscopy, the diagnosis of neurogenic disorders including dysphagia may be significantly improved, leading to a better clinical understanding of complex dysfunctional patterns. To the best of our knowledge, this is the first study to show that a retroflex view of the ultrathin video endoscope within the esophagus can be safely performed. [NCT01995929]

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

Effectiveness of Acupuncture in Postpartum Depression: A Systematic Review and Meta-Analysis

2018 ◽  
Vol 36 (5) ◽  
pp. 295-301 ◽  
Author(s):  
Shanshan Li ◽  
Weiqiang Zhong ◽  
Wen Peng ◽  
Gaofeng Jiang
Keyword(s):  
Postpartum Depression ◽  
Rating Scale ◽  
Meta Analysis ◽  
Depression Scale ◽  
Cochrane Collaboration ◽  
Clinical Effectiveness ◽  
Effective Rate ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Control Group

Objective To assess the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). Methods The following electronic databases were systematically searched: PubMed, Cochrane Library, SCI, Elsevier SDOL, China National Knowledge, Wan Fang database and Chinese Science and Technology Periodical Database. Only randomised controlled trials (RCTs) of acupuncture for PPD were considered. Primary outcomes were the Hamilton Rating Scale for Depression (HAMD) or the Edinburgh Postnatal Depression Scale (EPDS) scores and effective rate. Our secondary outcome was the level of oestradiol. The quality of all included trials was evaluated according to the Cochrane Collaboration. This protocol was registered in PROSPERO (CRD42016048528). Results Nine trials involving 653 women were selected. The result of this meta-analysis demonstrated that the acupuncture group had a significantly greater overall effective rate compared with the control group (seven trials, n=576, I2=24%; relative risk (RR) 1.15, 95% CI 1.06 to 1.24; P<0.001). Moreover, acupuncture significantly increased oestradiol levels compared with the control group (mean difference (MD) 36.92, 95% CI 23.14 to 50.71, P<0.001). Regarding the HAMD and EPDS scores, no difference was found between the two groups (five trials, n=276, I2=82%; MD−1.38, 95% CI −3.40 to 0.64; P=0.18; two trials, n=60, I2=16%; MD 1.08, 95% CI −1.09 to 3.26; P=0.33). Conclusions Acupuncture appears to be effective for postpartum depression with respect to certain outcomes. However, the evidence thus far is inconclusive. Further high-quality RCTs following standardised guidelines with a low risk of bias are needed to confirm the effectiveness of acupuncture for postpartum depression.

scholarly journals Randomized trial of transcranial alternating current stimulation for treatment of auditory hallucinations in schizophrenia

2018 ◽  
Vol 51 ◽  
pp. 25-33 ◽  
Author(s):  
Juliann M. Mellin ◽  
Sankaraleengam Alagapan ◽  
Caroline Lustenberger ◽  
Courtney E. Lugo ◽  
Morgan L. Alexander ◽  
...  
Keyword(s):  
Effect Size ◽  
Rating Scale ◽  
Auditory Hallucination ◽  
Alternating Current ◽  
Primary Outcome Measure ◽  
Auditory Hallucinations ◽  
Size Analysis ◽  
Symptom Improvement ◽  
Transcranial Alternating Current Stimulation ◽  
Secondary Outcomes

AbstractBackground:Approximately 30% of patients with schizophrenia experience auditory hallucinations that are refractory to antipsychotic medications. Here, we evaluated the feasibility and efficacy of transcranial alternating current stimulation (tACS) that we hypothesized would improve auditory hallucination symptoms by enhancing synchronization between the frontal and temporo-parietal areas of the left hemisphere.Method:22 participants were randomized to one of three arms and received twice daily, 20 min sessions of sham, 10 Hz 2 mA peak-to-peak tACS, or 2 mA tDCS over the course of 5 consecutive days. Symptom improvement was assessed using the Auditory Hallucination Rating Scale (AHRS) as the primary outcome measure. The Positive and Negative Syndrome Scale (PANSS) and the Brief Assessment of Cognition in Schizophrenia (BACS) were secondary outcomes.Results:Primary and secondary behavioral outcomes were not significantly different between the three arms. However, effect size analyses show that tACS had the greatest effect based on the auditory hallucinations scale for the week of stimulation (1.31 for tACS; 1.06 and 0.17, for sham and tDCS, respectively). Effect size analysis for the secondary outcomes revealed heterogeneous results across measures and stimulation conditions.Conclusions:To our knowledge, this is the first clinical trial of tACS for the treatment of symptoms of a psychiatric condition. Further studies with larger sample sizes are needed to better understand the effect of tACS on auditory hallucinations.

scholarly journals REiNS: Recommendations for Measurement of Attention Outcomes in Preschoolers With Neurofibromatosis

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012423
Author(s):  
Bonita P. Klein-Tasman ◽  
Kristin Lee ◽  
Heather L. Thompson ◽  
Jennifer Janusz ◽  
Jonathan M. Payne ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Rating Scale ◽  
Dimensional Change ◽  
Neurofibromatosis Type ◽  
Primary Outcome Measure ◽  
Attention Problems ◽  
Developmental Trajectory ◽  
Secondary Outcome ◽  
Increased Risk ◽  
Preschool Aged Children

Children with neurofibromatosis type 1 (NF1) are at increased risk for attention problems. While most research has been conducted with school-aged cohorts, preschool-aged children offer a novel developmental window for clinical studies, with the promise that treatments implemented earlier in the developmental trajectory may most effectively modify risk for later difficulties. Designing research studies around the youngest children with NF1 can result in intervention earlier in the developmental cascade associated with NF1 gene abnormalities. Furthermore, clinical trials for medications targeting physical and psychological aspects of NF1 often include individuals spanning a wide age range, including preschool-aged children. In a prior paper, the REiNS Neurocognitive Subcommittee made recommendations regarding performance-based and observer-rated measures of attention for use in clinical trials and highlighted the need for separate consideration of assessment methods for young children. The observer-rated ADHD Rating Scale – Preschool version is recommended as a primary outcome measure. The NIH Toolbox Flanker, Dimensional Change Card Sort, and List Sort Working Memory tasks and Digits Forward from the Differential Ability Scales – Second Edition (performance-based measures) are recommended as secondary outcome measures. Specific methodological recommendations for inclusion of preschoolers in clinical trials research are also offered.

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