scholarly journals Fetal surgery for spina bifida aperta

2018 ◽  
Vol 103 (6) ◽  
pp. F589-F595 ◽  
Author(s):  
Luc Joyeux ◽  
Enrico Danzer ◽  
Alan W Flake ◽  
Jan Deprest
Keyword(s):  
Spina Bifida ◽  
Prolonged Exposure ◽  
Controlled Trial ◽  
Fetal Surgery ◽  
Neurological Deficits ◽  
Cerebrospinal Fluid Leakage ◽  
Essential Information ◽  
Ventriculoperitoneal Shunting ◽  
Spina Bifida Aperta ◽  
Randomised Controlled

Spina bifida aperta (SBA) is one of the most common congenital malformations. It can cause severe lifelong physical and neurodevelopmental disabilities. Experimental and clinical studies have shown that the neurological deficits associated with SBA are not simply caused by incomplete neurulation at the level of the lesion. Additional damage is caused by prolonged exposure of the spinal cord and nerves to the intrauterine environment and a suction gradient due to cerebrospinal fluid leakage, leading to progressive downward displacement of the hindbrain. This natural history can be reversed by prenatal repair. A randomised controlled trial demonstrated that mid-gestational maternal-fetal surgery for SBA decreases the need for ventriculoperitoneal shunting and hindbrain herniation at 12 months and improves neurological motor function at 30 months of age. This came at the price of maternal and fetal risks, the most relevant ones being increased prematurity and a persistent uterine corporeal scar. Recently minimally invasive fetal approaches have been introduced clinically yet they lack extensive experimental or clinical trials. We aim to provide clinicians with the essential information necessary to counsel SBA parents as the basis for considering referral of selected patients to expert fetal surgery centres. We review the reported clinical outcomes and discuss recent developments of potentially less invasive fetal SBA approaches.

scholarly journals Randomised controlled trial of integrated trauma-focused psychotherapy for traumatic stress and substance use among adolescents: trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e043742
Author(s):  
Katherine L Mills ◽  
Emma Barrett ◽  
Sudie E Back ◽  
Vanessa E Cobham ◽  
Sarah Bendall ◽  
...  
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Traumatic Stress ◽  
Prolonged Exposure ◽  
Controlled Trial ◽  
Integrated Treatment ◽  
Post Traumatic Stress ◽  
Behavioural Treatment ◽  
Randomised Controlled

IntroductionPost-traumatic stress disorder (PTSD) and substance use disorder frequently co-occur and tend to have their onset during adolescence. Although research has highlighted the importance of treating these disorders in an integrated fashion, there is a dearth of empirically validated integrated treatment options for adolescents with this comorbidity. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy of an integrated trauma-focused cognitive–behavioural treatment for traumatic stress and substance use among adolescents (Concurrent Treatment of PTSD and Substance Use Using Prolonged Exposure - Adolescent (COPE-A)), relative to a supportive counselling control condition (Person-Centred Therapy (PCT)).Methods and analysisA two-arm, parallel, single-blind RCT with blinded follow-up at 4 and 12 months poststudy entry will be conducted in Sydney, Australia. Participants (n~100 adolescents aged 12–18 years) and their caregivers (caregiver participation is optional) will be allocated to undergo either COPE-A or PCT (allocation ratio 1:1) using minimisation. Both therapies will be delivered individually by project psychologists over a maximum of 16 sessions of 60–90 min duration and will include provision of up to four 30 min optional caregiver sessions. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for DSM-5.Ethics and disseminationEthical approval has been obtained from the human research ethics committees of the Sydney Children’s Hospital Network (HREC/17/SCHN/306) and the University of Sydney (HREC 2018/863). Findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numberACTRN12618000785202; Pre-reults.Protocol versionVersion 1, 31 July 2017.

scholarly journals Long-term outcomes of trauma-focused treatment in psychosis

2018 ◽  
Vol 212 (3) ◽  
pp. 180-182 ◽  
Author(s):  
David van den Berg ◽  
Paul A. J. M. de Bont ◽  
Berber M. van der Vleugel ◽  
Carlijn de Roos ◽  
Ad de Jongh ◽  
...  
Keyword(s):  
Social Functioning ◽  
Psychotic Disorders ◽  
Prolonged Exposure ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Positive Effects ◽  
Post Traumatic ◽  
Randomised Controlled ◽  
Emdr Therapy

SummaryWe present 12-month follow-up results for a randomised controlled trial of prolonged exposure and eye movement desensitisation and reprocessing (EMDR) therapy in 85 (78.8%) participants with psychotic disorder and comorbid post-traumatic stress disorder (PTSD). Positive effects on clinician-rated PTSD, self-rated PTSD, depression, paranoid-referential thinking and remission from schizophrenia were maintained up to 12-month follow-up. Negative post-traumatic cognitions declined in prolonged exposure and were stable in EMDR. A significant decline in social functioning was found, whereas reductions in interference of PTSD symptoms with social functioning were maintained. These results support that current PTSD guidelines apply to individuals with psychosis.Declaration of interestM.v.d.G. and D.v.d.B. receive income for published books on psychotic disorders and for the training of postdoctoral professionals in the treatment of psychotic disorders. A.d.J. receives income for published books on EMDR therapy and for the training of postdoctoral professionals in this method. A.v.M. receives income for published book chapters on PTSD and for the training of postdoctoral professionals in prolonged exposure. C.d.R. receives income for the training of postdoctoral professionals in EMDR therapy.

scholarly journals Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Erik Lundström ◽  
◽  
Eva Isaksson ◽  
Per Näsman ◽  
Per Wester ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Severe Heart Failure ◽  
Stroke Recovery ◽  
Neurological Deficits ◽  
Exclusion Criterion ◽  
Link Type ◽  
Parallel Group ◽  
Randomised Controlled

Abstract Studies have suggested that fluoxetine might improve neurological recovery after stroke, but the results remain inconclusive. The EFFECTS (Efficacy oF Fluoxetine – a randomisEd Controlled Trial in Stroke) reached its recruitment target of 1500 patients in June 2019. The purpose of this article is to present all amendments to the protocol and describe how we formed the EFFECTS trial collaboration in Sweden. Methods In this investigator-led, multicentre, parallel-group, randomised, placebo-controlled trial, we enrolled non-depressed stroke patients aged 18 years or older between 2 and 15 days after stroke onset. The patients had a clinical diagnosis of stroke (ischaemic or intracerebral haemorrhage) with persisting focal neurological deficits. Patients were randomised to fluoxetine 20 mg or matching placebo capsules once daily for 6 months. Results Seven amendments were made and included clarification of drug interaction between fluoxetine and metoprolol and the use of metoprolol for severe heart failure as an exclusion criterion, inclusion of data from central Swedish registries and the Swedish Stroke Register, changes in informed consent from patients, and clarification of design of some sub-studies. EFFECTS recruited 1500 patients at 35 centres in Sweden between 20 October 2014 and 28 June 2019. We plan to unblind the data in January 2020 and report the primary outcome in May 2020. Conclusion EFFECTS will provide data on the safety and efficacy of 6 months of treatment with fluoxetine after stroke in a Swedish health system setting. The data from EFFECTS will also contribute to an individual patient data meta-analysis. Trial registration EudraCT 2011-006130-16. Registered on 8 August 2014. ISRCTN, ISRCTN13020412. Registered on 19 December 2014. ClinicalTrials.gov: NCT02683213. Retrospectively registered on 2 February 2016.

Does a Myelomeningocele Sac Compared to No Sac Result in Decreased Postnatal Leg Function following Maternal Fetal Surgery for Spina Bifida Aperta?

2007 ◽  
Vol 22 (5) ◽  
pp. 348-351 ◽  
Author(s):  
R. Douglas Wilson ◽  
Mark P. Johnson ◽  
Michael Bebbington ◽  
Alan W. Flake ◽  
Holly L. Hedrick ◽  
...  
Keyword(s):  
Spina Bifida ◽  
Fetal Surgery ◽  
Spina Bifida Aperta

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy (Cipn): A Pilot Study Using Neurography

2012 ◽  
Vol 30 (1) ◽  
pp. 4-7 ◽  
Author(s):  
Sven Schroeder ◽  
Gesa Meyer-Hamme ◽  
Susanne Epplée
Keyword(s):  
Peripheral Neuropathy ◽  
Pilot Study ◽  
Medical Care ◽  
Controlled Trial ◽  
Specific Treatment ◽  
Nerve Conduction Studies ◽  
Neurological Deficits ◽  
Control Group ◽  
Randomised Controlled ◽  
Positive Effect

Objectives Chemotherapy-induced peripheral neuropathy (CIPN) can produce severe neurological deficits and neuropathic pain and is a potential reason for terminating or suspending chemotherapy treatments. Specific and effective curative treatments are lacking. Methods A pilot study was conducted to evaluate the therapeutic effect of acupuncture on CIPN as measured by changes in nerve conduction studies (NCS) in six patients treated with acupuncture for 10 weeks in addition to best medical care and five control patients who received the best medical care but no specific treatment for CIPN. Results In five of the six patients treated with acupuncture, NCS improved after treatment. In the control group, three of five patients did not show any difference in NCS, one patient improved and one showed impaired NCS. Conclusion The data suggest that acupuncture has a positive effect on CIPN. The encouraging results of this pilot study justify a randomised controlled trial of acupuncture in CIPN on the basis of NCS.

Prenatal Diagnosis and Patient Preferences in Patients with Neural Tube Defects around the Advent of Fetal Surgery in Belgium and Holland

2014 ◽  
Vol 37 (3) ◽  
pp. 226-234 ◽  
Author(s):  
Céline Ovaere ◽  
Alex Eggink ◽  
Jute Richter ◽  
Titia E. Cohen-Overbeek ◽  
Frank Van Calenbergh ◽  
...  
Keyword(s):  
Prenatal Diagnosis ◽  
Spina Bifida ◽  
Neural Tube ◽  
Neural Tube Defects ◽  
Fetal Surgery ◽  
Training Material ◽  
Spinal Lesions ◽  
Spina Bifida Aperta ◽  
Prenatal Management ◽  
Open Spina Bifida

Introduction: We review the characteristics and prenatal choices of patients recently evaluated for neural tube defects (NTD) at two tertiary units. The prenatal diagnosis of NTD allows parents to consider all prenatal options. In selected cases of spina bifida aperta this also includes fetal surgery, which we started offering after combined ‘in-house' and ‘exported' training. Material and Methods: This is a retrospective review of prospectively collected data on NTD diagnosed over the last 8 years and recent fetal surgery referrals. Results: A total of 167 patients were referred for assessment at a median of 19 weeks. Cranial lesions were diagnosed significantly earlier than spinal lesions. Of the open spinal lesions, 77% were isolated. Of these, 22% were managed expectantly and 1 (1%) had fetal surgery. There was no correlation between parental decisions on prenatal management with disease-specific severity markers. We had 14 fetal surgery referrals, all but 1 from beyond our typical referral area; 6 of the assessed patients were operated on, 4 were expectantly managed and 4 requested termination of pregnancy (TOP). These pregnancy outcomes were in the expected range. Discussion: Open spina bifida is mainly diagnosed in the second trimester and 76% of subjects request TOP, irrespective of the severity indicators. The number of local patients considering fetal surgery is low.

Integrated Trauma-Focused Psychotherapy for Traumatic Stress and Substance Use: Two Adolescent Case Studies

2021 ◽  
pp. 153465012110460
Author(s):  
Olivia Schollar-Root ◽  
Joanne Cassar ◽  
Natalie Peach ◽  
Vanessa E Cobham ◽  
Bronwyn Milne ◽  
...  
Keyword(s):  
Substance Use ◽  
Case Studies ◽  
Traumatic Stress ◽  
Prolonged Exposure ◽  
Controlled Trial ◽  
Integrated Treatment ◽  
Post Traumatic Stress ◽  
Clinical Case Studies ◽  
Randomised Controlled

Post-traumatic stress disorder (PTSD) and substance use disorder (SUD) occur frequently as comorbid diagnoses among adolescents. Historically, these conditions have been treated using a sequential model; however, emerging evidence suggests that an integrated treatment model may be most effective. This article presents two de-identified clinical case studies from an ongoing randomised controlled trial examining the efficacy of an integrated, exposure-based, cognitive-behavioral psychotherapy (CBT) for PTSD and SUD among adolescents (COPE-A), relative to a supportive counselling control condition (person-centred therapy). In both case studies, participants were randomised to receive the COPE-A integrated treatment, which incorporates prolonged exposure (PE) including imaginal and in vivo exposure as a core treatment component alongside CBT for PTSD and SUD. The clinical profile and treatment response of each participant is discussed. Promising results were found in both cases, with substantially reduced traumatic stress symptoms and decreased or stable levels of substance use by the end of treatment. Clinical implications of these early findings are discussed.

Fetal Surgery for Spina Bifida Aperta: To Be or Not to Be?

2002 ◽  
Vol 12 ◽  
pp. 22-24 ◽  
Author(s):  
M. Patricolo ◽  
G. Noia ◽  
F. Pomini ◽  
L. Perilli ◽  
E. lannace ◽  
...  
Keyword(s):  
Spina Bifida ◽  
Fetal Surgery ◽  
Spina Bifida Aperta

scholarly journals Open Fetal Microneurosurgery for Intrauterine Spina Bifida Repair

2021 ◽  
pp. 1-11
Author(s):  
Rogelio Cruz-Martínez ◽  
Felipe Chavelas-Ochoa ◽  
Miguel Martínez-Rodríguez ◽  
Karla Aguilar-Vidales ◽  
Alma Gámez-Varela ◽  
...  
Keyword(s):  
Spina Bifida ◽  
Amniotic Fluid ◽  
Open Surgery ◽  
Perinatal Death ◽  
Fetal Surgery ◽  
Perinatal Outcomes ◽  
Surgery Technique ◽  
Ventriculoperitoneal Shunting ◽  
Surgery Center

<b><i>Objectives:</i></b> The aim of the study was to describe the feasibility of open fetal microneurosurgery for intrauterine spina bifida (SB) repair and to compare perinatal outcomes with cases managed using the classic open fetal surgery technique. <b><i>Methods:</i></b> In this study, we selected a cohort of consecutive fetuses with isolated open SB referred to our fetal surgery center in Queretaro, Mexico, during a 3.5-year period (2016–2020). SB repair was performed by either classic open surgery (6- to 8-cm hysterotomy with leakage of amniotic fluid, which was replaced before uterine closure) or open microneurosurgery, which is a novel technique characterized by a 15- to 20-mm hysterotomy diameter, reduced fetal manipulation by fixing the fetal back, and maintenance of normal amniotic fluid and uterine volume during the whole surgery. Perinatal outcomes of cases operated with the classic open fetal surgery technique and open microneurosurgery were compared. <b><i>Results:</i></b> Intrauterine SB repair with a complete 3-layer correction was successfully performed in 60 cases either by classic open fetal surgery (<i>n</i> = 13) or open microneurosurgery (<i>n</i> = 47). No significant differences were observed in gestational age (GA) at fetal intervention (25.4 vs. 25.1 weeks, <i>p</i> = 0.38) or surgical times (107 vs. 120 min, <i>p</i> = 0.15) between both groups. The group with open microneurosurgery showed a significantly lower rate of oligohydramnios (0 vs. 15.4%, <i>p</i> = 0.01), preterm rupture of the membranes (19.0 vs. 53.8%, <i>p</i> = 0.01), higher GA at birth (35.1 vs. 32.7 weeks, <i>p</i> = 0.03), lower rate of preterm delivery &#x3c;34 weeks (21.4 vs. 61.5%, <i>p</i> = 0.01), and lower rate of perinatal death (4.8 vs. 23.1%, <i>p</i> = 0.04) than the group with classic open surgery. During infant follow-up, the rate of hydrocephalus requiring ventriculoperitoneal shunting was similar between both groups (7.5 vs. 20%, <i>p</i> = 0.24). All patients showed an intact hysterotomy site at delivery. <b><i>Conclusion:</i></b> Intrauterine spina repair by open fetal microneurosurgery is feasible and was associated with better perinatal outcomes than classic open fetal surgery.

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