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5,826 results for “Randomized trial”
Serial correlation of temporal pain intensities with beta-endorphin and meta-enkephalin concentrations, following Transcutaneous Electrical Nerve Stimulation among patients with chronic low back pain: a randomized controlled trial
<p>This is a dataset for the research that evaluate the responses of plasma beta-endorphin (βE), met-enkephalin (ME) and pain intensity (PI) among patients with chronic low back pain exposed to transcutaneous electrical nerve stimulation (TENS) = Group 1 or sham-TENS = Group 2.</p> <p>The dataset codes: TENS group = 1, Sham-TENS = 2, Sex: male = 1, female = 2, Baseline = before trial, Zero_Hr = immediately after trial, One_Hr = an hour after trial, TwentyFour_Hrs = 24 hrs after trial, FortyEight_Hrs = 48 hrs after trial.</p> <p>Variables labels: group, sex, age, pain duration, systolic blood pressure (SBP), diastolic blood pressure (DBP), resting heart rate (RHR), body temperature (Temp), beta-endorphin (BE), meta-enkephalin (ME), pain intensity (PI) measured with numeric pain scale.</p> <p>To describe time series, codes were combined with variable labels E.g. TwentyFour_Hrs_BE = bete endorphin concentration after 24 hrs of intervention.</p>
Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: an open-label randomized controlled trial in Lesotho
<p>These are pseudo-anonymised data from the SESOTHO randomised trial: "Switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL – a multicenter, parallel-group, open-label, randomized clinical study in rural Lesotho". There are two datasets, one containing baseline data (one row per participant) and one containing longitudinal viral load data (one row per participant per visit). The data dictionary explains the data available in each dataset. Between August 2017 and August 2019, 80 eligible and consenting participants were enrolled from eight health facilities in four districts of Lesotho, and followed up for nine months. The protocol was published, DOI: 10.1186/s12879-018-2979-y</p>
Randomized trial of AKI alerts in hospitalized patients
<p><b>Objective: </b>To determine whether electronic health record (EHR) alerts for Acute Kidney Injury (AKI) would improve patient outcomes of mortality, dialysis and progression of AKI. </p> <p><b>Design: </b>Double-blinded, multicenter, parallel, randomized, controlled trial of an electronic AKI alert versus usual care (no alert). Participants were electronically identified and randomized via a best practice alert build using simple randomization with allocation concealment.</p> <p><b>Setting:</b> Six diverse hospitals (four teaching and two non-teaching) ranging from small community hospitals to large tertiary care centers.</p> <p><b>Participants:</b> 6,030 adult inpatients with AKI, as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) creatinine criteria.</p> <p><b>Interventions:</b> An EHR-based "pop-up" alert for AKI with an associated AKI order set upon provider opening of the patient's medical record.</p> <p><b>Main Outcome Measures: </b>A composite of AKI progression, receipt of dialysis, or death within 14 days of randomization. Pre-specified secondary outcomes included per-hospital outcome rates and rates of various AKI care practices. </p> <p><b>Results: </b>6,030 patients were randomized over 22 months. The primary outcome occurred in 653 (21.4%) patients in the alert group and 622 (20.9%) in the usual care group (relative risk 1.02, 95% confidence interval [CI] 0.93 to 1.13, p=0.67). Per-hospital analysis revealed worse outcomes in the two non-teaching hospitals (N=765, 13%), where alerts were associated with a relative risk of the primary outcome of 1.49 (95% CI, 1.12 to 1.98, p=0.006). More deaths (15.6% in the alert group vs. 8.6% in the usual care group) occurred at these centers (p=0.003). Certain AKI care practices were increased in the alert group but did not appear to mediate these outcomes.</p> <p><b>Conclusions: </b>Alerts did not reduce rates of our primary outcome among hospitalized patients with AKI. The overall lack of clinical benefit and signals of harm in non-teaching hospitals should lead to a re-evaluation of existing AKI alerting systems.</p> <p><b>Trial Registration: </b>ClinicalTrials.gov NCT02753751.</p>
Individualized Nutritional Support versus Usual Care in Medical Inpatients at Risk of Malnutrition: Randomized Trial
<p>Dataset for analysis of the trial "Individualized Nutritional Support versus Usual Care in Medical Inpatients at Risk of Malnutrition"</p>
Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials
Background: Primaquine (PQ) actively clears mature Plasmodium falciparum gametocytes but in glucose-6-phosphate dehydrogenase deficient (G6PDd) individuals can cause hemolysis. We assessed the safety of low-dose PQ in combination with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) in G6PDd African males with asymptomatic P. falciparum malaria. Methods and findings: In Burkina Faso, G6PDd adult males were randomized to treatment with AL alone (n = 10) or with PQ at 0.25 (n = 20) or 0.40 mg/kg (n = 20) dosage; G6PD-normal males received AL plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. In The Gambia, G6PDd adult males and boys received DP alone (n = 10) or with 0.25 mg/kg PQ (n = 20); G6PD-normal males received DP plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. The primary study endpoint was change in hemoglobin concentration during the 28-day follow-up. Cytochrome P-450 isoenzyme 2D6 (CYP2D6) metabolizer status, gametocyte carriage, haptoglobin, lactate dehydrogenase levels and reticulocyte counts were also determined. In Burkina Faso, the mean maximum absolute change in hemoglobin was -2.13 g/dL (95% confidence interval [CI], -2.78, -1.49) in G6PDd individuals randomized to 0.25 PQ mg/kg and -2.29 g/dL (95% CI, -2.79, -1.79) in those receiving 0.40 PQ mg/kg. In The Gambia, the mean maximum absolute change in hemoglobin concentration was -1.83 g/dL (95% CI, -2.19, -1.47) in G6PDd individuals receiving 0.25 PQ mg/kg. After adjustment for baseline concentrations, hemoglobin reductions in G6PDd individuals in Burkina Faso were more pronounced compared to those in G6PD-normal individuals receiving the same PQ doses (P = 0.062 and P = 0.022, respectively). Hemoglobin levels normalized during follow-up. Abnormal haptoglobin and lactate dehydrogenase levels provided additional evidence of mild transient hemolysis post-PQ. Conclusions: Single low-dose PQ in combination with AL and DP was associated with mild and transient reductions in hemoglobin. None of the study participants developed moderate or severe anemia; there were no severe adverse events. This indicates that single low-dose PQ is safe in G6PDd African males when used with artemisinin-based combination therapy.
Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial
<p>This file contains the original data underpinning the article in npj vaccines, in which we describe a phase 1 safety and immunogenicty study on the malaria vaccine candidate MSP1 in humans. The abstract of the article follows:</p> <p>A vaccine remains a priority in the global fight against malaria. Here, we report on a single-center, randomized, double-blind, placebo and adjuvant-controlled, dose escalation phase 1a safety and immunogenicity clinical trial of full-length <i>Plasmodium falciparum</i> merozoite surface protein 1 (MSP1) in combination with GLA-SE adjuvant. 32 healthy volunteers were vaccinated at least three times with MSP1 plus adjuvant, adjuvant alone or placebo (24:4:4) to evaluate the safety and immunogenicity. MSP1 was safe, well tolerated and immunogenic, with all vaccinees sero-converting independent of the dose. The MSP1-specific IgG and IgM titers persisted above levels found in malaria semi-immune humans for at least six months after the last immunization. The antibodies were variant- and strain-transcending and stimulated respiratory activity in granulocytes. Furthermore, full-length MSP1 induced memory T-cells. Our findings encourage challenge studies as the next step to evaluate the efficacy of full-length MSP1 as a vaccine candidate against falciparum malaria (EudraCT 2016-002463-33).</p>
CONSORT flow diagram for The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial
<p><strong>The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by </strong>a <strong>clinical pharmacist: a randomized clinical trial</strong>.</p>
HypnoChild: A prospective randomized trial to reduce perioperative anxiety and postoperative discomfort in children using a hypnosis intervention before tonsillotomy and adenoidectomy
<p><strong>Introduction</strong>: Children undergoing tonsillotomy (TT) or adenoidectomy (AT) often suffer from anxiety before and pain or nausea after the procedure. Greater preoperative anxiety in children and their parents is associated with increased postoperative discomfort. The aim of the HypnoChild study is to reduce perioperative anxiety with a preoperative hypnosis intervention and thereby alleviate postoperative discomfort.</p><p><strong>Material/Methods</strong>: In a previous pilot study, we developed a narcosis comic with a little monkey as the protagonist to reduce children's preoperative anxiety. In HypnoChild, we investigated whether a hypnosis audio intervention further reduces children's perioperative anxiety. Here, the little monkey describes the surgery as an adventurous space journey. We included children 3-6 years old receiving TT or AT. 34 children prepared for surgery with the hypnosis audio intervention in addition to the comic (comic+hypnosis group), while 30 children received the comic only (comic group). All children received premedication by midazolam. We measured children's subjective well-being before and after surgery, parents' anxiety before surgery, children's anxiety during surgery, and children's postoperative pain and nausea.</p><p><strong>Results</strong>: Children showed high well-being before and after surgery in both groups. Parents' anxiety was on a moderate level in both groups. Children's anxiety was low to moderate in both groups during surgery. In the postoperative telephone interviews, children reported medium pain ratings in both groups with no significant differences in any postoperative outcome between groups.</p><p><strong>Conclusion</strong>: Our study shows that all children participating in our study reported high well-being and low anxiety undergoing TT or AT. We conclude that apparently children already received adequate preoperative treatment by routine care. In future studies, it should be assessed if the combination of non-medical interventions like comic and hypnosis shows an additive effect in non-medicated children.</p><p>This research was funded by a DFG grant to Dr. Barbara Schmidt, SCHM 3129/5-1</p>
Data from: A randomized controlled safety and feasibility trial of floatation-REST in anxious and depressed individuals
<div> <div> <div> <div> <p>Background: Reduced Environmental Stimulation Therapy via floatation (floatation- REST) is a behavioral intervention designed to attenuate exteroceptive sensory input to the nervous system. Prior studies in anxious and depressed individuals demonstrated that single sessions of floatation-REST are safe, well-tolerated, and associated with an acute anxiolytic and antidepressant effect that persists for over 48 hours. However, the feasibility of using floatation-REST as a repeated intervention in anxious and depressed populations has not been well-investigated.</p> <p>Methods: In this single-blind safety and feasibility trial, 75 individuals with anxiety and depression were randomized to complete six sessions of floatation-REST in different formats: pool-REST (weekly 1-hour float sessions), pool-REST preferred (float sessions with flexibility of duration and frequency), or an active comparator (chair- REST; weekly 1-hour sessions in a Zero Gravity chair). Feasibility (primary outcome) was assessed via an 80% rate of adherence to the assigned intervention; tolerability via study dropout and duration/frequency of REST utilization; and safety via incidence of adverse events and ratings about the effects of REST.</p> <p>Results: Of 1,715 individuals initially screened, 75 participants were ultimately randomized. Six-session adherence was 85% for pool-REST (mean, M=5.1 sessions; standard deviation, SD=1.8), 89% for pool-REST preferred (M=5.3 sessions; SD=1.6), and 74% for chair-REST (M=4.4 sessions; SD=2.5). Dropout rates at the end of the intervention did not differ significantly between the treatment conditions. Mean session durations were 53.0 minutes (SD=12.3) for pool-REST, 75.4 minutes (SD=29.4) for pool-REST preferred, and 58.4 minutes (SD=4.3) for chair-REST. There were no serious adverse events associated with any intervention. Positive experiences were endorsed more commonly than negative ones and were also rated at higher levels of intensity.</p> <p>Conclusions: Six sessions of floatation-REST appear feasible, well-tolerated, and safe in anxious and depressed individuals. Floatation-REST induces positively-valenced experiences with few negative effects. Larger randomized controlled trials evaluating markers of clinical efficacy are warranted.</p> <p>Clinical Trial Registration Identifier: NCT03899090</p> </div> </div> </div> </div>
Design and implementation of a brief digital mindfulness and compassion training app for health care professionals: cluster randomized controlled trial
<p><strong>Background: </strong>Several studies show that intense work schedules make health care professionals particularly vulnerable to emotional exhaustion and burnout.</p> <p><strong>Objective:</strong> In this scenario, promoting self-compassion and mindfulness may be beneficial for well-being. Notably, scalable, digital app–based methods may have the potential to enhance self-compassion and mindfulness in health care professionals.</p> <p><strong>Methods: </strong>In this study, we designed and implemented a scalable, digital app–based, brief mindfulness and compassion training program called "WellMind" for health care professionals. A total of 22 adult participants completed up to 60 sessions of WellMind training, 5-10 minutes in duration each, over 3 months. Participants completed behavioral assessments measuring self-compassion and mindfulness at baseline (preintervention), 3 months (postintervention), and 6 months (follow-up). In order to control for practice effects on the repeat assessments and calculate effect sizes, we also studied a no-contact control group of 21 health care professionals who only completed the repeated assessments but were not provided any training. Additionally, we evaluated preand postintervention neural activity in core brain networks using electroencephalography source imaging as an objective<br>neurophysiological training outcome.</p> <p><strong>Results:</strong> Findings showed a post- versus preintervention increase in self-compassion (Cohen d=0.57; P=.007) and state-mindfulness (d=0.52; P=.02) only in the WellMind training group, with improvements in self-compassion sustained at follow-up (d=0.8; P=.01). Additionally, WellMind training durations correlated with the magnitude of improvement in self-compassion across human participants (ρ=0.52; P=.01). Training-related neurophysiological results revealed plasticity specific to the default mode network (DMN) that is implicated in mind-wandering and rumination, with DMN network suppression selectively observed at the postintervention time point in the WellMind group (d=–0.87; P=.03). We also found that improvement in self-compassion was directly related to the extent of DMN suppression (ρ=–0.368; P=.04).</p> <p><strong>Conclusions:</strong> Overall, promising behavioral and neurophysiological findings from this first study demonstrate the benefits of brief digital mindfulness and compassion training for health care professionals and compel the scale-up of the digital intervention.</p>
Data from: Use of the lung flute ECO to assist in sputum collection for tuberculosis testing: a randomized crossover trial
<p>The Lung Flute ECO, a self-powered, low cost, oscillatory positive expiratory pressure (OPEP) device, assisted people with presumptive tuberculosis to produce an adequate sputum volume for diagnostic testing and was well-tolerated.</p>
Evaluation of comparative Efficacy of two routes of administration of Carathmus Tinctorius (Medicated Enema and Nasal Administration) as an Adjuvant Therapy with Standard Care With Physiotherapy in the Rehabilitation of Thrombolytic Stroke (Pakshaghat): A Randomized Controlled Trial Protocol
Open the record for dataset details and reuse information.
Evaluation of comparative efficacy of Trayodashang Guggul versus Asitaka Churna Vati in the management of Katigraha (Stiffness in Lumbar Region): A randomized controlled trial protocol
Open the record for dataset details and reuse information.
Capacitive resistive monopolar radiofrequency at 448 kHz plus exercise versus exercise alone for subacromial pain: Randomized sham-controlled clinical trial.
<p>Objective: To investigate the effectiveness of thermal and sub-thermal capacitive resistive 448kHz monopolar radiofrequency (CRMRF) plus exercise compared to Sham CRMRF plus exercise on pain, functionality, and quality of life in patients with subacromial pain.</p> <p>Material and methods: A randomized sham-controlled double blind clinical trial was designed. Eighty-one participants with subacromial pain were enrolled and randomly assigned to three intervention groups (Thermal CRMRF, Sub-thermal CRMRF, and Sham CRMRF). The main outcomes variables were for pain: visual analogic scale (VAS) and pressure pain threshold, for functionality: shoulder pain and disability index (SPADI) and Quick- Disabilities of the Arm, Shoulder and Hand (Quick-DASH) and for quality of life: European Quality of Live Five Dimensions (EQ-5D). Variables were measured at baseline, post-intervention, and at one-month and three months follow-ups. An intention-to-treat analysis was realized.</p> <p>Results: All three groups statistically (p<0.01) and clinically significantly improved pain (VAS) and functionality (SPADI) respect to baseline at post-intervention and follow-up periods. The improvement in Quick-DASH outcome respect to baseline at one month follow-up was clinically relevant only in the thermal CRMRF group (-16.8 points; CI95% -27.3 to -6.3). Thermal-CRMRF group showed a greater effect on Quick-DASH at one month follow-up (-14.1 points, CI95% -28.1 to -0.1) compared with Sham-CRMRF group. EQ-5D measure at one month follow-up only improved in thermal-CRMRF group (0.12 points; CI95% 0.01 to 0.23). Only thermal-CRMRF group improved the pressure pain threshold outcome (0.42 kg/cm<sup>2 </sup>CI95% 0.05 to 0.79) at post-treatment.</p>
Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh
<p>We ran a randomized trial of mask promotion in Bangladesh; the intervention increased mask-use and reduced symptomatic SARS-CoV-2 infections.</p>
dataset of test trial with random pattern generator
<p>test session of a mems based random caustic-pattern generator. In this session we collected the experimental patterns that have helped us understand the physics and functioning of the device that we used, moreover these patterns are being used to train a neural network that will aid us to perform computational ghost imaging experiments with electrons.</p>
Association between prenatal provision of lipid‐based nutrient supplements and cesarean delivery: Findings from a randomized controlled trial in Malawi
<p>Data set for a published manuscript on Maternal & Child Nutrition.</p> <p><strong>ABSTRACT:</strong> In populations with a high prevalence of childhood and adolescent undernutrition, supplementation during pregnancy aiming at improving maternal nutritional status and preventing fetal growth restriction might theoretically lead to cephalopelvic disproportion and delivery complications. We investigated whether the prenatal provision of small-quantity lipid-based nutrient supplements (SQ-LNS) was associated with an increased risk of caesarean section (CS) or other delivery complications. Pregnant Malawian women were randomised to receive daily i) iron–folic acid (IFA) capsule (control), ii) multiple micronutrient (MMN) capsule of 18 micronutrients (second control), or iii) SQ-LNS with similar micronutrients as MMN, plus four minerals and macronutrients contributing 118 kcal. We analysed the associations of SQ-LNS, CS, and other delivery complications using log-binomial regressions. Among 1391 women enrolled, 1255 had delivery information available. The incidence of CS and delivery complications was 6.3% and 8.2%, respectively. The incidence of CS was 4.0%, 6.0%, and 8.9% (p = 0.017) in the IFA, MMN, and LNS groups, respectively. Compared to the IFA group, the relative risk (95% confidence interval) of CS was 2.2 (1.3–3.8) (p = 0.006) in the LNS group and 1.5 (0.8–2.7) (p = 0.200) in the MMN group. We found no significant differences for other delivery complications. Provision of SQ-LNS to pregnant women may have increased the incidence of CS. The baseline rate was, however, lower than recommended. It is unclear if the higher CS incidence in the SQ-LNS group resulted from increased obstetric needs or more active health seeking and a better supply of services. Trial registered at clinicaltrials.gov, NCT01239693.</p>
Adverse effects of remdesivir, hydroxychloroquine, and lopinavir/ritonavir when used for COVID-19: systematic review and meta-analysis of randomized trials
<p><strong>Background</strong>: To summarize specific adverse effects of remdesivir, hydroxychloroquine, and lopinavir/ritonavir in patients with COVID-19.</p> <p><strong>Methods</strong>: We searched 32 databases through 27 October 2020. We included randomized trials comparing any of the drugs of interest to placebo or standard care, or against each other. We conducted fixed-effects pairwise meta-analysis and assessed the certainty of evidence using the GRADE approach.</p> <p><strong>Results</strong>: We included 16 randomized trials which enrolled 8226 patients. For most interventions and outcomes the certainty of the evidence was very low to low except for gastrointestinal adverse effects from hydroxychloroquine, which was moderate certainty. Compared to standard care or placebo, low certainty evidence suggests that remdesivir may not have an important effect on acute kidney injury or cognitive dysfunction/delirium. Low certainty evidence suggests that hydroxychloroquine may increase the risk of cardiac toxicity (and cognitive dysfunction/delirium, whereas moderate certainty evidence suggests hydroxychloroquine probably increases the risk of diarrhoea (RD 106 more per 1000, 95% CI: 48 more to 175 more) and nausea and/or vomiting (RD 62 more per 1000, 95% CI: 23 more to 110 more) compared to standard care or placebo. Low certainty evidence suggests lopinavir/ritonavir may increase the risk of diarrhoea and nausea and/or vomiting compared to standard care or placebo.</p> <p><strong>Discussion</strong>: Hydroxychloroquine probably increases the risk of diarrhoea and nausea and/or vomiting and may increase the risk of cardiac toxicity and cognitive dysfunction/delirium. Lopinavir/ritonavir may increase the risk of diarrhoea and nausea and/or vomiting. Remdesivir may have no important effect on risk of acute kidney injury or cognitive dysfunction/delirium. These findings provide important information to support the development of evidence-based management strategies for patients with COVID-19.</p> <p><strong>Funding</strong>: This study was supported by the Canadian Institutes of Health Research (grant: VR4-172738)</p> <p><strong>Registration</strong>: Not registered in PROSPERO, protocol available in the supplementary material of BMJ 2020;370:m2980; http://dx.doi.org/10.1136/bmj.m2980.</p>
Remodeling dental anatomy vs sham therapy for chronic temporomandibular disorders: A placebo-controlled randomized clinical trial
<div><em>Background</em></div> <div>Evidence regarding the etiology or effective treatments for chronic orofacial pain, the majority diagnosed as temporomandibular disorder (TMD), is limited.</div> <div> </div> <div><em>Purpose</em></div> <div>To investigate whether occlusal equilibration therapy (ET) and decreasing the (higher) angle of the lateral guidance on the nonworking-side leads to a reduction in chronic TMDs intensity.</div> <div> </div> <div><em>Methods</em></div> <div>It was conducted a randomized, explanatory, single blind with blinded assessment, placebo-controlled trial with strong protection against bias involving patients with chronic TMDs. Participants were randomly assigned to receive equilibration therapy or sham therapy. ET in this study consisted of minimal invasive occlusal remodeling to obtain balanced occlusion with reduction of the steeper angle of lateral mandibular movement with respect to the Frankfort plane. The primary outcome was a change in the pain intensity score (on a 0–10 point scale, with 0 indicating no pain and 10 the worst possible pain) at month 6. Secondary outcomes include maximum unassisted mouth opening and psychological distress.</div> <div> </div> <div><em>Results</em></div> <div>A total of 77 participants underwent randomization, 39 of whom received ET and 38 sham therapy. The trial was stopped early for efficacy, according to preestablished rules when 67 participants (n = 34, n = 33, respectively) had completed the analysis. At month 6, the mean unadjusted pain intensity score was 2.1 in the ET and 3.6 in the sham therapy group (adjusted mean difference, −1.54; 95% confidence interval [CI] −0.5 to −2.6; P = 0.004; ANCOVA model). The mean increase in maximum unassisted mouth opening (main secondary outcome) was significantly higher in the real therapy group (adjusted mean difference 3.1 mm, 95% CI 0.5–5.7, p = 0.02).</div> <div> </div> <div><em>Conclusion</em></div> <div>ET significantly reduced the intensity of facial pain associated with chronic TMDs and increased maximum unassisted mouth opening, as compared with sham therapy, over the course of 6 months. There were no serious adverse events.</div>
Data from: Neurofeedback facilitation enhances post-stroke gait and balance recovery: a randomized trial
<p><strong>Objective:</strong> To test the hypothesis that supplementary motor area (SMA) facilitation with functional near-infrared spectroscopy mediated neurofeedback (fNIRS-NFB) augments post-stroke gait and balance recovery using the 3-meter-Timed Up-and-Go (TUG) test, we conducted this two-center, double-blind, randomized controlled trial involving 54 Japanese patients.</p> <p><strong>Methods:</strong> Patients with subcortical stroke-induced mild-to-moderate gait disturbance more than 12 weeks from onset, underwent 6 sessions of SMA neurofeedback facilitation during gait- and balance-related motor imagery using fNIRS-NFB. Participants were randomly allocated to intervention (REAL: 28 patients) or placebo (SHAM: 26 patients) group. In the REAL group, the fNIRS signal contained participants' cortical activation information. Primary outcome was TUG improvement, 4 weeks post intervention.</p> <p><strong>Results: </strong>The REAL group showed greater improvement in the TUG test (12.84 ± 15.07 s, 95% CI: 7.00-18.68) than the SHAM group (5.51± 7.64 s, 95% CI: 2.43 – 8.60; group difference 7.33 s, 95% CI: 0.83 – 13.83; p = 0.028), even after adjusting for covariates (group × time interaction; F1.23,61.69 = 4.50, p = 0.030, partial η2 = 0.083). Only the REAL group showed significantly increased imagery-related SMA activation and enhancement of resting-state connectivity between SMA and ventrolateral premotor area. Adverse effects associated with fNIRS-mediated neurofeedback intervention were absent.</p> <p><strong>Conclusion:</strong> SMA facilitation during motor imagery using fNIRS neurofeedback may augment post-stroke gait and balance recovery by modulating the SMA and its related network.</p> <p><strong>Classification of Evidence:</strong> This study provides Class III evidence that for patients with gait disturbance from subcortical stroke, SMA neurofeedback facilitation improves TUG time. (UMIN000010723 at UMIN-CTR http://www.umin.ac.jp/english/)</p>
ScienceDex guides
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These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.