Surgical outcome of motor deficits and neurological status in brainstem cavernous malformations based on preoperative diffusion tensor imaging: a prospective randomized clinical trial

2018 ◽  
Vol 130 (1) ◽  
pp. 286-301 ◽  
Author(s):  
Da Li ◽  
Yu-Ming Jiao ◽  
Liang Wang ◽  
Fu-Xin Lin ◽  
Jun Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diffusion Tensor Imaging ◽  
Muscle Strength ◽  
Surgical Approach ◽  
Diffusion Tensor ◽  
Entry Point ◽  
Motor Deficits ◽  
Control Group ◽  
Cavernous Malformations ◽  
Randomized Controlled

OBJECTIVESurgical management of brainstem lesions is challenging due to the highly compact, eloquent anatomy of the brainstem. This study aimed to evaluate the safety and efficacy of preoperative diffusion tensor imaging (DTI) and diffusion tensor tractography (DTT) in brainstem cavernous malformations (CMs).METHODSA prospective randomized controlled clinical trial was performed by using stratified blocked randomization. The primary eligibility criterion of the study was being a surgical candidate for brainstem CMs (with informed consent). The study enrolled 23 patients who underwent preoperative DTI/DTT and 24 patients who did not (the control group). The pre- and postoperative muscle strength of both limbs and modified Rankin Scale (mRS) scores were evaluated. Muscle strength of any limb at 12 months after surgery at the clinic visit was the primary outcome; worsened muscle strength was considered to be a poor outcome. Outcome assessors were blinded to patient management. This study reports the preliminary results of the interim analysis.RESULTSThe cohort included 47 patients (22 women) with a mean age of 35.7 years. The clinical baselines between these 2 groups were not significantly different. In the DTI/DTT group, the corticospinal tract was affected in 17 patients (73.9%): it was displaced, deformed/partially interrupted, or completely interrupted in 6, 7, and 4 patients, respectively. The surgical approach and brainstem entry point were adjusted in 3 patients (13.0%) based on DTI/DTT data. The surgical morbidity of the DTI/DTT group (7/23, 30.4%) was significantly lower than that of the control group (19/24, 79.2%, p = 0.001). At 12 months, the mean mRS score (1.1, p = 0.034) and percentage of patients with worsened motor deficits (4.3%, p = 0.006) were significantly lower in the DTI/DTT group than in the control group (1.7% and 37.5%). Multivariate logistic regression identified the absence of preoperative DTI/DTT (OR 0.06, 95% CI 0.01–0.73, p = 0.028) and use of the 2-point method (OR 4.15, 95% CI 1.38–12.49, p = 0.011) as independent adverse factors for a worsened motor deficit. The multivariate model found a significant correlation between poor mRS score and both an increased preoperative mRS score (t = 3.559, p = 0.001) and absence of preoperative DTI/DTT (t = −2.747, p = 0.009).CONCLUSIONSDTI/DTT noninvasively allowed for visualization of the anatomical relationship between vital tracts and pathologies as well as facilitated the brainstem surgical approach and entry-point decision making. The technique was valuable for complex neurosurgical planning to reduce morbidity. Nonetheless, DTI/DTT data should be interpreted cautiously.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class I.Clinical trial registration no.: NCT01758211 (ClinicalTrials.gov)

scholarly journals Diffusion-tensor imaging (DTI) and tractography (DTT) in the surgical planning of brainstem cavernous malformations

2021 ◽  
Author(s):  
Maria Julia Melchiades Costa ◽  
Talita Cardoso Gomes ◽  
Ana Luíza Pinheiro de Mello ◽  
Luiz Müller Pimentel Delfim Lacerda ◽  
Ivan Magalhães Viana
Keyword(s):  
Diffusion Tensor Imaging ◽  
Surgical Planning ◽  
Diffusion Tensor ◽  
Case Reports ◽  
Motor Deficits ◽  
Surgical Morbidity ◽  
Cavernous Malformations ◽  
Surgical Safety ◽  
Pubmed Database ◽  
And Diffusion

Background: Brainstem Cavernous Malformations (BSCMs) are vascular alterations that allow blood to pass into the central nervous tissue. When surgery is indicated, the preoperative use of DTI/DTT appears to improve prognosis. Objectives: Analyze the use of DTI/DTT in the surgical planning of BSCMs and their prognostic repercussions. Methods: An integrative review in which 25 articles in English from the last 14 years were found in the Pubmed database in April 2021, using the descriptors “brainstem”, “cavernous malformations” and “diffusion tensor imaging” and the boolean operator “And”. 4 articles from 2015 to 2021 were selected. Exclusion criteria: (1) Reviews; (2) Case reports; (3) Unrelated topic. Results: BSCMs commonly distort the region’s tracts, whose location and direction can be determined by DTI/DTT, offering a safer surgical planning. In a series with 10 BSCMs patients, in which 5 underwent preoperative DTI, 64% of the analyzed fibers presented some deformation, with 2 patients needing to have their surgical plan altered. A randomized clinical trial analyzed 23 BSCMs patients who underwent preoperative DTI/DTT and 24 conventionally evaluated, surgical morbidity and the percentage of patients with worsened motor deficits were lower in the DTI/DTT group (30,4% and 1,7%) than control (79,2% and 37,5%), indicating that such techniques may have better results. Conclusion: Preoperative DTI/DTT appears to be related to a better prognosis and surgical safety. However, further studies are needed to confirm its effectiveness in improving the prognosis of BSCMs patients.

scholarly journals The role of diffusion tensor imaging and tractography in the surgical management of brainstem gliomas

2021 ◽  
Vol 50 (1) ◽  
pp. E10
Author(s):  
Xiong Xiao ◽  
Lu Kong ◽  
Changcun Pan ◽  
Peng Zhang ◽  
Xin Chen ◽  
...  
Keyword(s):  
Diffusion Tensor Imaging ◽  
Muscle Strength ◽  
Surgical Management ◽  
Diffusion Tensor ◽  
Tumor Resection ◽  
Glioma Surgery ◽  
Cavernous Malformations ◽  
Before And After ◽  
Subcortical Stimulation ◽  
Planning Guide

OBJECTIVEDiffusion tensor imaging (DTI) and diffusion tensor tractography (DTT) have the ability to noninvasively visualize changes in white matter tracts, as well as their relationships with lesions and other structures. DTI/DTT has been increasingly used to improve the safety and results of surgical treatment for lesions in eloquent areas, such as brainstem cavernous malformations. This study aimed to investigate the application value of DTI/DTT in brainstem glioma surgery and to validate the spatial accuracy of reconstructed corticospinal tracts (CSTs).METHODSA retrospective analysis was performed on 54 patients with brainstem gliomas who had undergone surgery from January 2016 to December 2018 at Beijing Tiantan Hospital. All patients underwent preoperative DTI and tumor resection with the assistance of DTT-merged neuronavigation and electrophysiological monitoring. Preoperative conventional MRI and DTI data were collected, and the muscle strength and modified Rankin Scale (mRS) score before and after surgery were measured. The surgical plan was created with the assistance of DTI/DTT findings. The accuracy of DTI/DTT was validated by performing direct subcortical stimulation (DsCS) intraoperatively. Multiple linear regression was used to investigate the relationship between quantitative parameters of DTI/DTT (such as the CST score and tumor-to-CST distance [TCD]) and postoperative muscle strength and mRS scores.RESULTSAmong the 54 patients, 6 had normal bilateral CSTs, 12 patients had unilateral CST impairments, and 36 had bilateral CSTs involved. The most common changes in the CSTs were deformation (n = 29), followed by deviation (n = 28) and interruption (n = 27). The surgical approach was changed in 18 cases (33.3%) after accounting for the DTI/DTT results. Among 55 CSTs on which DsCS was performed, 46 (83.6%) were validated as spatially accurate by DsCS. The CST score and TCD were significantly correlated with postoperative muscle strength (r = −0.395, p < 0.001, and r = 0.275, p = 0.004, respectively) and postoperative mRS score (r = 0.430, p = 0.001, and r = −0.329, p = 0.015, respectively). The CST score was independently linearly associated with postoperative muscle strength (t = −2.461, p = 0.016) and the postoperative mRS score (t = 2.052, p = 0.046).CONCLUSIONSDTI/DTT is a valuable tool in the surgical management of brainstem gliomas. With good accuracy, it can help optimize surgical planning, guide tumor resection, and predict the postoperative muscle strength and postoperative quality of life of patients.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

Heart Rate Variability And Respiratory Muscle Strength In Patients With Type Ii Diabetes Practicing Pilates: A Randomized Clinical Trial

2021 ◽  
Vol 17 ◽  
Author(s):  
Samara Sousa Vasconcelos Gouveia ◽  
Guilherme Pertinni de Morais Gouveia ◽  
Leydnaya Maria Souza ◽  
Bruno Cunha da Costa ◽  
Gustavo Henrique Melo Sousa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Muscle Strength ◽  
Normal Distribution ◽  
Randomized Clinical Trial ◽  
Respiratory Muscle ◽  
Control Group ◽  
Respiratory Muscle Strength

Purpose: This study aimed to analyze the effect of a Pilates protocol on respiratory muscle strength and heart rate variability (HRV) in patients with type 2 diabetes. Method: A randomized clinical trial (RBR-2gc2qj) was conducted with a type 2 diabetic target population. Patients practiced the Pilates protocol for 8 weeks, with two visits per week. The variables tested were maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and HRV (time and frequency domains). All variables were tested for normal distribution. Using SPSS 21.0, analysis of variance was performed for variables with normal distribution, and the Wilcoxon and Friedman tests were used for variables that did not show a normal distribution, with a 5% significance level. Results: Forty-four participants were included in the study (intervention group: 22; control group: 22; mean age: 61.23 ± 8.49 years), most of whom were female (77.3%), married or in a consensual union (59.1%), had complete literacy (31.8%), and had an average body mass index of 26.96 ± 4.35 kg/m2. There were no significant differences in MIP and MEP before and after the protocol between the intervention and control groups. Regarding HRV, there were significant differences in autonomic modulation, especially between the moments before and during exercise and between the moments during and after exercise; however, it was not possible to determine which system (sympathetic or parasympathetic) is most involved in these changes. Conclusion: The exercise protocol based on the Pilates method did not alter respiratory muscle strength but promoted changes in HRV, especially between the moments before and during exercise and during and after exercise.

Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors—A Pilot Randomized Controlled Study

2021 ◽  
pp. 109980042110502
Author(s):  
Zhan Liang ◽  
Hilary Yip ◽  
Kimberly Sena Moore ◽  
Tanira Ferreira ◽  
Ming Ji ◽  
...  
Keyword(s):  
Muscle Strength ◽  
Lower Extremity ◽  
Active Control ◽  
Exercise Intervention ◽  
Controlled Study ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled ◽  
Left And Right ◽  
The Mean

Objective The objective of this study was to evaluate effects of a self-managed music-guided exercise intervention on muscle strength among intensive care unit (ICU) survivors. Methods We used a two-arm randomized-controlled trial. Following ICU discharge, eligible participants were assigned to one of two groups: music group ( n = 13) or active control group ( n = 13). The music group was taught to self-manage upper and lower extremity exercise movements by listening to an individualized music-guided playlist twice daily for 5 days. The active control group was provided an exercise brochure and advised to perform the same exercises at the same intervals. Dynamometers were used to measure muscle strength. T-tests and Weighted GEE models were used for testing the intervention effect between groups. Results Twenty-six subjects were enrolled. The mean age was 62.8 ( SD = 13.8), 53.8% were male, 65.4% were Caucasian, and the mean APACHE severity of illness score was 59 ( SD = 23.4). Reasons for ICU admission were mainly cardiac and medical. The music group showed significant improvements in handgrip, plantar flexion, leg extension, elbow flexion, and shoulder adduction strengths on left and right sides. Additionally, left and right leg extensor and left plantar flexor strengths showed significant post-differences, and small to moderately large effect sizes, between the music group and control group. Conclusion These findings suggest that a music-guided exercise intervention has the potential to improve muscle strength in ICU survivors and prevent further post-ICU deterioration in ICU survivors. Future trials should build upon these preliminary findings.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals Primary progressive aphasia patients evaluated using diffusion tensor imaging and voxel based volumetry-preliminary results

2011 ◽  
Vol 69 (3) ◽  
pp. 446-451 ◽  
Author(s):  
Fábio Pascotto de Oliveira ◽  
Jaderson Costa da Costa ◽  
Sabine Possa Marroni ◽  
Ana Maria Marques da Silva ◽  
Sthefanie Hansen Barreiro ◽  
...  
Keyword(s):  
Diffusion Tensor Imaging ◽  
Cognitive Deficits ◽  
Diffusion Tensor ◽  
Primary Progressive Aphasia ◽  
Control Group ◽  
Progressive Aphasia ◽  
Primary Progressive ◽  
Language Deficit ◽  
Volume Method ◽  
Diffusion Tensor Imaging Dti

There are individuals who have a progressive language deficit without presenting cognitive deficits in other areas. One of the diseases related to this presentation is primary progressive aphasia (PPA). OBJECTIVE: Identify by means of diffusion tensor imaging (DTI) and measurements of cortical volume, brain areas that lead to dysphasia when presenting signs of impaired connectivity or reduced volume. METHOD: Four patients with PPA were evaluated using DTI, and measurements of cortical volumes in temporal areas. These patients were compared with two normal volunteers. RESULTS: There is a trend to a difference in the number and volume of related fibers between control group and patients with PPA. Comparing cortical volumes in temporal areas between groups yielded a trend to a smaller volume in PPA patients. CONCLUSION: Patients with PPA have a trend to impairment in cortical and subcortical levels regarding relevant areas.

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