Patient Experiences of Neurofeedback for Chemotherapyinduced Peripheral Neuropathy: A Case Series Comparing Real and Placebo Treatment

Background: A major concern in interventional studies is the inability to accurately link patient report with objective measures. In this study, we associated functional brain measures with self-reported pain after patients underwent a neuromodulatory intervention. Specifically, Chemotherapy-Induced Peripheral Neuropathy (CIPN) adversely affects many cancer patients but few effective treatment options are available, and mechanisms are not well understood. Objectives: We present three representative cases from a doubleblind, randomized, placebo-controlled trial which examined the efficacy of a targeted therapy of Electroencephalogram (EEG) Neurofeedback (NFB), in attenuating symptoms of CIPN. The primary outcome of the trial was efficacy of neurofeedback versus control groups. In this case series we explore mechanism, by linking patient reported outcomes with objective measures. Methods: Symptom descriptions and EEG data were collected for patients enrolled in neurofeedback, placebo feedback, and waitlist conditions. Subjective pain ratings and EEG data were compared before and after the 10-week intervention. Results: A patient receiving neurofeedback demonstrated decreased beta oscillations in Brodmann Area 6 (BA6) and reported noticeable decreases in numbness and temperature sensitivity. A patient receiving placebo demonstrated increased beta in BA6 and increased alpha oscillations in Brodmann areas 3 and 7 with improvement of symptoms. A waitlist participant showed no change in BA6 and reported increased neuropathic symptoms while on waitlist but subsequently received NFB treatment and reported symptom improvement. Conclusions: This case series indicates that NFB may be used to achieve targeted reduction in beta oscillations to treat CIPN. Possible mechanisms of action and implications for CIPN treatment are discussed.

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Topical Cannabinoids for Treating Chemotherapy-Induced Neuropathy: A Case Series

Integrative Cancer Therapies ◽

10.1177/15347354211061739 ◽

2021 ◽

Vol 20 ◽

pp. 153473542110617

Author(s):

Stacy D’Andre ◽

Sean McAllister ◽

Jasdeepa Nagi ◽

Karthik V. Giridhar ◽

Eduardo Ruiz-Macias ◽

...

Keyword(s):

Peripheral Neuropathy ◽

Mayo Clinic ◽

Side Effect ◽

Controlled Trial ◽

Treatment Options ◽

Case Series ◽

Mechanisms Of Action ◽

Chemotherapeutic Agents ◽

Severe Side Effect ◽

Case Presentations

Background Chemotherapy-induced peripheral neuropathy is a common and often severe side effect from many chemotherapeutic agents, with limited treatment options. There is no literature on the use of topical cannabinoids for chemotherapy-induced neuropathy. Case Presentations The current manuscript presents a case series of patients presenting in oncology clinics at Sutter Health, CA and Mayo Clinic, Rochester, MN from April 2019 to December 2020 with chemotherapy-induced peripheral neuropathy who used topical creams containing the cannabinoids delta-nine-tetrahydrocannabinol (THC) and/or cannabidiol (CBD). Conclusions This case series suggests that topical cannabinoids may be helpful for patients with chemotherapy-induced peripheral neuropathy. This paper also discusses the potential mechanisms of action by which topical cannabinoids might alleviate established CIPN symptoms. A randomized placebo-controlled trial using a standardized product is planned to study the actual efficacy of such treatment.

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Need for standard outcome reporting systems in craniosynostosis

Neurosurgical FOCUS ◽

10.3171/2011.6.focus1192 ◽

2011 ◽

Vol 31 (2) ◽

pp. E1 ◽

Cited By ~ 18

Author(s):

Caroline Szpalski ◽

Katie Weichman ◽

Fabio Sagebin ◽

Stephen M. Warren

Keyword(s):

Health Care Professionals ◽

Treatment Options ◽

Case Series ◽

Functional Results ◽

Series Data ◽

Quality Level ◽

Complication Rates ◽

Outcome Reporting ◽

Radiographic Measurements ◽

Patient Reported

Craniosynostosis is the premature fusion of one or more cranial sutures. When a cranial suture fuses prematurely, skull growth is altered and the head takes on a characteristic pathological shape determined by the suture(s) that fuses. Numerous treatment options have been proposed, but until recently there were no parameters or guidelines of care. Establishing such parameters was an important step forward in the treatment of patients with craniosynostosis, but results are still assessed using radiographic measurements, complication rates, and ad hoc reporting scales. Therefore, clinical outcome reporting in the treatment of craniosynostosis is inconsistent and lacks methodological rigor. Today, most reported evidence in the treatment of craniosynostosis is level 5 (expert opinion) or level 4 (case series) data. Challenges in obtaining higher quality level 1 or level 2 data include randomizing patients in a clinical trial as well as selecting the appropriate outcome measure for the trial. Therefore, determining core outcome sets that are important to both patients and health care professionals is an essential step in the evolution of caring for patients with craniosynostosis. Traditional clinical outcomes will remain important, but patient-reported outcomes, such as satisfaction, body image, functional results, and aesthetic outcomes, must also be incorporated if the selected outcomes are to be valuable to patients and families making decisions about treatment. In this article, the authors review the most commonly used tools to assess craniosynostosis outcomes and propose a list of longitudinal parameters of care that should be considered in the evaluation, diagnosis, and treatment evaluation of a patient with craniosynostosis.

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Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study

10.21203/rs.3.rs-1016582/v1 ◽

2021 ◽

Author(s):

Richard Collings ◽

Jennifer Freeman ◽

Jos M Latour ◽

Joanne Paton

Keyword(s):

Peripheral Neuropathy ◽

Qualitative Study ◽

Active Control ◽

Thematic Analysis ◽

Plantar Pressure ◽

Diabetic Peripheral Neuropathy ◽

Controlled Trial ◽

Plantar Pressures ◽

Patient Reported ◽

Feasibility Rct

Abstract Background: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimizing plantar foot pressure reduction in people with diabetes has been developed. Aim: To explore the feasibility and acceptability of testing an optimized insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy.Methods: A double-blinded multicentre feasibility RCT with an embedded qualitative study. In addition to usual care, participants were randomized to either an optimized insole group (Intervention) or a standard cushioned insole group (Active control). Participants were assessed at baseline, 3, 6 and 12 months with clinical outcome of mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analyzed using descriptive statistics (quantitative data) and thematic analysis (qualitative data).Results: Screened were142 patients from which 61 were recruited; 30 participants were randomized to the Intervention group and 31 to the Active control group. Forty-two participants completed the study. At 12-months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. Mean difference in MPPP between the Intervention and Active control groups for all regions-of-interest combined favoured the Intervention, with increases from 87kPa at post-randomization to 255kPa at 12-months. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. Conclusion: The results of the feasibility RCT suggest that the optimized insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. Trial registration: International Standard Randomized Controlled Trial Number: ISRCTN16011830. Registered 9th October 2017, https://www.isrctn.com/ISRCTN16011830

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CTNI-32. CASE SERIES OF BRAF INHIBITORS FOR THE TREATMENT OF BRAFV600E GLIOBLASTOMA

Neuro-Oncology ◽

10.1093/neuonc/noab196.257 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi66-vi66

Author(s):

Naveed Wagle ◽

Jose Carrillo ◽

Akanksha Sharma ◽

Minhdan Nguyen ◽

Judy Truong ◽

...

Keyword(s):

Standard Therapy ◽

Target Therapy ◽

Controlled Trial ◽

Treatment Options ◽

Objective Response ◽

Case Series ◽

Braf V600e ◽

Molecular Profile ◽

Braf Inhibitors ◽

Mri Imaging

Abstract Glioblastoma is the most common and aggressive primary brain tumor. Beyond upfront therapy with radiation and temozolomide chemotherapy there is no standard therapy that has been effective. Inhibitors of BRAF and MEK, a downstream protein immediately following BRAF, have been shown to have survival benefit for patients with other BRAF V600E mutant neoplasm including advanced melanoma. We describe our experience using this combined target therapy for two patients with BRAF V600E mutant glioblastoma. Two adult patients with pathologically diagnosed glioblastoma presented with radiographic evidence of tumor progression after prior treatment with chemotherapy or immunotherapy. Neither had received radiation therapy within 3 months of starting treatment. Molecular characterization was performed though Caris which showed evidence of BRAF V600E mutation. BRAF inhibitors were initiated in combination with standard therapy options. MRI imaging was obtained to monitor for disease progression. BRAF inhibitors were tolerated well without any side effects not previously reported. Partial objective response was seen in both patients on subsequent MRI imaging within 8 weeks of starting treatment. Progression free survival and overall survival have not been reached in either case. BRAF inhibition may have therapeutic benefit in BRAF mutated glioblastoma. Partial response was seen in this case series. The molecular profile of glioblastoma may suggest treatment options beyond standard chemotherapy options. This series supports the use of BRAF inhibitors for the treatment of BRAFV600E glioblastoma A controlled trial should be supported.

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Lurasidone for Adolescents With Complex Mental Disorders: A Case Series

Journal of Pharmacy Practice ◽

10.1177/0897190021997011 ◽

2021 ◽

pp. 089719002199701

Author(s):

Tom B. Mole ◽

Yulia Furlong ◽

Richard J. Clarke ◽

Pradeep Rao ◽

Julia K. Moore ◽

...

Keyword(s):

Treatment Options ◽

Real Life ◽

Case Series ◽

Antipsychotic Agent ◽

Case Note ◽

Symptom Improvement ◽

Clinical Settings ◽

Retrospective Case ◽

Mood Symptoms ◽

Case Note Review

Objectives: Lurasidone is a new second generation (atypical) antipsychotic agent with unique receptor affinity and side-effect profiles, but limited literature is available on its use in adolescent populations. Contrasting with research treatment trials which typically recruit patients by stringent selection criteria, this case series examined the effects and tolerability of using lurasidone in adolescents within real-life clinical settings in treating complex cases who had not responded to other therapy options. Methods: We conducted a retrospective case-note audit of 6 adolescents aged 14 to 17 years old attending community child and adolescent mental health services (CAMHS) who were prescribed lurasidone. Results: Lurasidone had been prescribed for a range of “hard-to-manage” conditions with complex comorbidities, in adolescents in relation to specific use of lurasidone on the basis of clinical and pharmacological indications after exhausting more conventional treatment options. Case-note review suggested response to lurasidone was clinically positive in 3 cases, equivocal/marginal in 2 cases, and ineffective in 1 case. There were no cases of poor tolerance or adverse effects. Notably, positive responses for depressive and irritable mood symptoms were specifically recorded by prescribing clinicians, indicative of benefits on symptom improvement. No lurasidone attributed weight gain, galactorrhoea, metabolic abnormalities, sexual dysfunction or intolerance were reported. Pro-cognitive effects were not detected; but our findings were constrained by the non-systematic and incomplete information ascertainment, typical in retrospective case-note review. Conclusion: This case series provides preliminary data supporting lurasidone’s potential use in adolescents of complex clinical needs (but without a clinical diagnosis of bipolar disorder) within real-life clinical settings. Lurasidone appears to show a weight-sparing effect, in addition to improving mood symptoms in some cases. Lurasidone deserves further study for its use in the adolescent population (outside the remit of FDA) given its potential more favorable risk-benefit profile in young people. The favorable tolerability appear to be borne out by the pharmacodynamic predictions in our complex patients who would be excluded in formal clinical trial studies.

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Results and lessons learnt from a randomized controlled trial: Prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG)

10.21203/rs.2.501/v1 ◽

2019 ◽

Author(s):

Otmar Bayer ◽

Christine Adrion ◽

Amani Al Tawil ◽

Ulrich Mansmann ◽

Michael Strupp

Keyword(s):

Controlled Trial ◽

Psychometric Evaluation ◽

Placebo Treatment ◽

Vestibular Migraine ◽

University Hospitals ◽

Double Blind ◽

Episodic Vertigo ◽

Efficacy Outcome ◽

Patient Reported ◽

Full Analysis

Abstract BACKGROUND Vestibular migraine (VM) is the most frequent cause of recurrent spontaneous attacks of vertigo causally related to migraine. The objective of the PROVEMIG trial was to demonstrate that metoprolol succinate is superior to placebo treatment in the prevention of episodic vertigo- and migraine-related symptoms in patients with VM. METHODS This phase 3, two-arm parallel-group, double-blind, randomized placebo-controlled trial was designed to be conducted at tertiary referral centres at neurology and ENT departments of eight German university hospitals. The planned sample size was a total of 266 patients to be allocated. Adults aged 18 years or above diagnosed with probable or definitive VM according to the Neuhauser criteria 2001 were randomly assigned 1:1 to six months blinded metoprolol (maintenance dosage of 95 mg daily) versus placebo treatment policy. The primary efficacy outcome was the self-reported number of vertiginous attacks per 30 days documented by means of a paper-based daily symptom diary. The pre-specified time period of primary interest was defined within month 4 to 6. Secondary outcomes included the patient-reported number of migraine days and vertigo days, the Dizziness Handicap Inventory and clinical assessments. Adverse events were reported throughout the whole 9-month study period. RESULTS At the time of trial termination, no evidence for a difference in the incidence of vertiginous attacks between both treatment groups was detected. For the full analysis set, the incidence rate ratio (IRR) was 0.983 (95% confidence interval (CI), 0.902 to 1.071) for metoprolol vs. placebo. There was a significant decline in the overall monthly vertigo attacks by the factor 0.830 (95% CI, 0.776 to 0.887). Results were consistent for all subjective and objective key measures of efficacy. The treatment was well tolerated with no unexpected safety findings. CONCLUSIONS Due to poor participant accrual not related to the tolerability of the study medication or safety concerns PROVEMIG had to be discontinued after randomizing 130 patients. Additional preparatory work is much-needed in the development, psychometric evaluation and interpretation of clinically meaningful endpoints in trials on episodic syndromes like VM taking into consideration the two-dimensional aspect of this disease entity. TRIAL REGISTRATION EudraCT no 2009-013701-34, prospectively registered on 08 April 2011, https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-013701-34/DE.

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Antimicrobial agents for the treatment of enteric fever chronic carriage: A systematic review

10.1101/2021.11.09.21266081 ◽

2021 ◽

Author(s):

Naina McCann ◽

Peter Scott ◽

Christopher Parry ◽

Michael Brown

Keyword(s):

Systematic Review ◽

Enteric Fever ◽

Antimicrobial Agents ◽

Case Reports ◽

Controlled Trial ◽

Meta Analysis ◽

Treatment Options ◽

Case Series ◽

Bibliographic Databases ◽

Chronic Carriage

Background Chronic carriage of S . Typhi or S. Paratyphi is an important source of enteric fever transmission. Existing guidance and treatment options for this condition are limited. This systematic review aims to assess the evidence concerning the efficacy of different antimicrobials in treating enteric fever chronic carriage. Methods We searched major bibliographic databases using relevant keywords between 1946 and September 2021. We included all interventional studies that included patients with confirmed enteric fever chronic carriage and deployed an antimicrobial that remains in clinical practice today. Case reports and case series of under 10 patients were excluded. Two reviewers screened abstracts, selected articles for final inclusion and quality-assessed the included studies for risk of bias. Extracted data was analysed, with pooling of data and eradication rates for each antimicrobial calculated. As only one randomised controlled trial was identified no meta-analysis was performed. Results Of the 593 papers identified by the initial search, a total of eight studies met the inclusion criteria and were included in the systematic review. Evidence was identified for the use of fluoroquinolones and amoxicillin/ampicillin in the treatment for enteric fever chronic carriage. Fluoroquinolones were superior to amoxicillin/ampicillin with 92% of patients eradicated after one antimicrobial course compared to 68% (p = 0.02). The quality of included studies was poor, and all were carried out before 1990. Conclusion This review identified fluoroquinolones and amoxicillin as treatment options for enteric fever chronic carriage, with fluoroquinolones the more effective option. However, this evidence pre-dates rises in antimicrobial resistance in enteric fever and therefore the significance of these findings to today’s practice is unclear. Further research is needed to investigate whether these antimicrobials remain appropriate treatment options or whether alternative interventions are more effective.

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Current Concepts

Hand ◽

10.1177/1558944716643293 ◽

2016 ◽

Vol 11 (4) ◽

pp. 396-402 ◽

Cited By ~ 3

Author(s):

Jacob M. Kirsch ◽

Jared Thomas ◽

Asheesh Bedi ◽

Jeffrey N. Lawton

Keyword(s):

Literature Search ◽

Treatment Options ◽

Case Series ◽

Controlled Vocabulary ◽

Current Evidence ◽

Osteochondral Lesions ◽

Imaging Studies ◽

Painful Condition ◽

Review Articles ◽

Patient Reported

Background: Osteochondritis dissecans (OCD) of the capitellum is a painful condition, which often affects young throwing athletes. Our current understanding regarding the etiology, risks factors, diagnosis, and efficacy of the available treatment options has expanded over recent years, however remains suboptimal. Recent data on patient-reported outcomes following osteochondral autograft transplantation (OAT) for the treatment of large osteochondral lesions of the capitellum have been promising but limited. This review seeks to critically analyze and summarize the available literature on the etiology, diagnosis, and reported outcomes associated with OCD of the capitellum and the use of OAT for its treatment. Methods: A comprehensive literature search was conducted. Unique and customized search strategies were formulated in PubMed, Embase, Scopus, Web of Science, and CENTRAL. Combinations of keywords and controlled vocabulary terms were utilized in order to cast a broad net. Relevant clinical, biomechanical, anatomic and imaging studies were reviewed along with recent review articles, and case series. Results: Forty-three articles from our initial literature search were found to be relevant for this review. The majority of these articles were either review articles, clinical studies, anatomic or imaging studies or biomechanical studies. Conclusions: Current evidence suggests that OAT may lead to better and more consistent outcomes than previously described methods for treating large OCD lesions of the capitellum.

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The impact of blinding on patient-reported outcomes (PROs) in randomized controlled trials of immune checkpoint inhibitors versus traditional chemotherapies.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e23160 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e23160-e23160

Author(s):

James Dickerson ◽

Evan Thomas Hall ◽

Surbhi Singhal ◽

Brooke Peterson Gabster ◽

Lidia Schapira

Keyword(s):

Immune Checkpoint ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Controlled Trial ◽

Case Series ◽

Symptom Burden ◽

Open Label ◽

Patient Reported ◽

The Impact ◽

Blinded Trial

e23160 Background: Immune checkpoint inhibitors (ICIs) have been met with a wave of excitement due to their novel mechanism. We hypothesized that this may impact how patients (via PROs) report treatment tolerability in comparison to traditional therapies. We sought to examine if there was a notable difference in PROs in blinded vs unblinded trials of ICIs. Methods: We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus in August 2018 for publications with quantitative PRO data comparing ICIs to cytotoxic chemotherapy. Case series, narrative reviews, and publications lacking original data were excluded. Eligible publications were reviewed to assess if patients were blinded to the agent received, and a comparison for common PRO metrics was performed. Results: Of the 1,450 unique references identified, eight met inclusion criteria: 1 double blinded placebo-controlled trial and 7 trials where patients were aware of the assigned arm. The blinded trial had quantitative PRO data in the form of the European Organisation for Research and Treatment of Cancer (EORTC) global health status (GHS) score and patient reported symptom burden at week 12. Most (6 of 7; 86%) unblinded trials reported the GHS at either week 12 or 15, and patient symptom burden at these time points as well (5 of 7; 71%). For the EORTC GHS, the blinded trial showed no inter-arm difference at week 12. 4 of 6 (67%) open label trials noted statistically significant differences in GHS favoring the ICI arm. For symptom burden at week 12 or 15, there was no difference found in the blinded study. In unblinded trials, there were domains where patients receiving ICIs reported a statistically significant lower symptom burden than those receiving chemotherapy: fatigue (4 of 5 trials favoring ICIs; 80%), dyspnea (2 of 5; 40%), insomnia (1 of 4; 25%), appetite loss (1 of 4; 25%), and diarrhea (1 of 5; 20%). There were no differences in pain (n = 5), nausea/vomit (n = 5), and constipation (n = 5). Conclusions: We found a trend towards more favorable reporting on common symptoms in unblinded studies of patients receiving ICIs. Our analysis is limited by the lack of available comparisons in the published literature.

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A pilot randomized trial of meniscal allograft transplantation versus personalized physiotherapy for patients with a symptomatic meniscal deficient knee compartment

The Bone & Joint Journal ◽

10.1302/0301-620x.100b1.bjj-2017-0918.r1 ◽

2018 ◽

Vol 100-B (1) ◽

pp. 56-63 ◽

Cited By ~ 25

Author(s):

N. A. Smith ◽

N. Parsons ◽

D. Wright ◽

C. Hutchinson ◽

A. Metcalfe ◽

...

Keyword(s):

Controlled Trial ◽

Statistical Significance ◽

Case Series ◽

Mean Difference ◽

Meniscal Allograft Transplantation ◽

Allograft Transplantation ◽

Meniscal Transplantation ◽

Meniscal Allograft ◽

Patient Reported ◽

Deficient Knee

Aims Meniscal allograft transplantation is undertaken to improve pain and function in patients with a symptomatic meniscal deficient knee compartment. While case series have shown improvements in patient reported outcome measures (PROMs), its efficacy has not been rigorously evaluated. This study aimed to compare PROMs in patients having meniscal transplantation with those having personalized physiotherapy at 12 months. Patients and Methods A single-centre assessor-blinded, comprehensive cohort study, incorporating a pilot randomized controlled trial (RCT) was performed on patients with a symptomatic compartment of the knee in which a (sub)total meniscectomy had previously been performed. They were randomized to be treated either with a meniscal allograft transplantation or personalized physiotherapy, and stratified for malalignment of the limb. They entered the preference groups if they were not willing to be randomized. The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score and Lysholm score and complications were collected at baseline and at four, eight and 12 months following the interventions. Results A total of 36 patients entered the study; 21 were randomized and 15 chose their treatments. Their mean age was 28 years (range 17 to 46). The outcomes were similar in the randomized and preference groups, allowing pooling of data. At 12 months, the KOOS4 composite score (mean difference 12, p = 0.03) and KOOS subscales of pain (mean difference 15, p = 0.02) and activities of daily living (mean difference 18, p = 0.005) were significantly superior in the meniscal transplantation group. Other PROMs also favoured this group without reaching statistical significance. There were five complications in the meniscal transplantation and one in the physiotherapy groups. Conclusion This is the first study to compare meniscal allograft transplantation to non-operative treatment. The results provide the best quality evidence to date of the symptomatic benefits of meniscal allograft transplantation in the short term, but a multicentre RCT is required to investigate this question further. Cite this article: Bone Joint J 2018;100-B:56–63.

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