The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue in Participants With Primary Sjögren's Syndrome.

OBJECTIVES: Fatigue is one of the most important symptoms needing improvement in Primary Sjögren's syndrome (PSS). Previous data from our group suggest that noninvasive stimulation of the vagus nerve (nVNS) may improve symptoms of fatigue. This experimental medicine study uses the gammaCore device (electroCore) and a sham device to investigate the relationship between nVNS and fatigue in PSS, and to explore potential mechanisms involved. MATERIALS AND METHODS: Forty participants with PSS were randomly assigned to use active (n = 20) or sham (n = 20) nVNS devices twice daily for 54 days in a double-blind manner. Patient-reported measures of fatigue were collected at baseline and day 56: Profile of Fatigue (PRO-F)-Physical, PRO-F-Mental and Visual Analogue Scale of abnormal fatigue (fVAS). Neurocognitive tests, immunologic responses, electroencephalography alpha reactivity, muscle acidosis, and heart rate variability were compared between devices from baseline to day 56 using analysis of covariance. RESULTS: PRO-F-Physical, PRO-F-Mental, and fVAS scores were significantly reduced at day 56 in the active group only (p = 0.02, 0.02, and 0.04, respectively). Muscle bioenergetics and heart rate variability showed no change between arms. There were significant improvements in digit span and a neurocognitive test (p = 0.03), and upon acute nVNS stimulation, frontal region alpha reactivity showed a significant negative relationship with fatigue scores in the active group (p < 0.01). CONCLUSIONS: We observed significant improvements in three measures of fatigue at day 56 with the active device but not the sham device. Directly after device use, fatigue levels correlate with measures of alpha reactivity, suggesting modulation of cholinergic system integrity as a mechanism of action for nVNS.

Impact of the covid-19 pandemic on amyotrophic lateral sclerosis care in the UK.

The Covid-19 pandemic has impacted healthcare. Our aim was to identify how amyotrophic lateral sclerosis (ALS) care in the UK has been affected by the pandemic by exploring the experiences of people living with ALS (plwALS), healthcare professionals (HCPs) working with plwALS, and ALS care centers. Three surveys were carried out to explore the experiences of plwALS, HCPs and ALS care centers during the pandemic. Quantitative data were analyzed using descriptive and inferential statistics and triangulated with the qualitative data which were analyzed thematically. Responses from 53 plwALS, 73 HCPs and 23 ALS care centers were analyzed. Five main themes were identified: keeping safe, losses, negative emotions, delivering care and alternative care delivery in a pandemic. PlwALS and HCPs felt that care was sub-optimal as a result of the pandemic. Changes to care included longer waiting times and face-to-face appointments being canceled or replaced by virtual consultations. While benefits of virtual consultations were reported, concerns were raised about incomplete clinical assessments and the disruption of provision of testing and interventions. ALS care has changed as a result of the pandemic. Patients have had a lack of face-to-face contact with HCPs and have experienced delays to investigations and treatments. PlwALS and HCPs were concerned about the impact of this change, but the long-term implications remain unclear. We propose recommendations for HCPs caring for plwALS, that will promote continuity of evidenced based care in the context of a pandemic.

Partner outcomes from an uncontrolled trial of Couple HOPES: A guided online couple intervention for posttraumatic stress disorder and relationship enhancement.

Posttraumatic stress disorder (PTSD) is associated with significant individual and relationship impairment for people with PTSD and their romantic partners. Conjoint treatments, such as cognitive behavioral conjoint therapy for PTSD (CBCT), are designed to address individual and relationship factors, yet significant barriers impede accessing in-person therapy. Couple HOPES (i.e., Helping Overcome PTSD and Enhance Satisfaction) is a coach-guided, online couple intervention for PTSD based on CBCT that was designed to address these barriers. Previous investigations have found preliminary efficacy of Couple HOPES for improving PTSD symptoms, relationship functioning, and some individual functioning domains for the partner with probable PTSD. However, no study to date has tested individual outcomes for romantic partners, which is needed to fully evaluate the intervention's promise. The current study tested these partner outcomes in a combined, uncontrolled sample of 27 couples. Intent-to-intervene analyses found significant improvements at postintervention in four of eight tested outcomes, including ineffective arguing, g = 0.74; anger, g = 0.32; perceived health, g = 0.67; and quality of life, g = 0.56. Depressive symptoms, generalized anxiety, alcohol misuse, and work functioning did not significantly change, gs = 0.17-0.42. Among participants who completed a 1-month follow-up assessment, generalized anxiety, g = 0.43, and perceived health, g = 0.73, significantly improved over follow-up, whereas anger, g = -0.48, lost gains previously made. Results were largely consistent in the completer sample. These findings show the potential of Couple HOPES to have broad benefits not only for individuals with probable PTSD but also for their romantic partners.

An uncontrolled trial of couple HOPES: A guided online couple intervention for PTSD and relationship enhancement.

Novel interventions that overcome limited access to empirically supported psychotherapies for posttraumatic stress disorder (PTSD) are sorely needed. Couple helping overcome PTSD and enhance relationships (HOPES), a guided, online couple intervention drawing from cognitive-behavioral conjoint therapy (CBCT) for PTSD (Monson, 2012), was designed to decrease PTSD symptoms and improve relationship satisfaction. The present study is the first uncontrolled trial of 17 couples in which one partner was a military member, veteran, or first responder and had probable PTSD (PTSD + partner) based on self-report assessment. Intent-to-intervene analyses revealed significant improvements from pre- to postintervention in PTSD + partners' self-reported PTSD symptoms (g = .72), as well as their intimate partner's relationship satisfaction (g = .34) and behavioral accommodation of PTSD symptoms (g = .84). There were also significant improvements in PTSD + partners' depression (g = .43) and perceived relationship arguments (g = .62). There were similar results found in the completer sample. There were no adverse events and high satisfaction with the intervention in those who completed the evaluation. These findings provide additional initial data on the safety, feasibility, and efficacy of Couple HOPES. The similarities of intent-to-intervene and completer results, as well as the need for randomized controlled trial designs to test Couple HOPES, are discussed. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Initial outcomes of couple HOPES: A guided online couple intervention for PTSD and relationship enhancement.

Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction) is a guided, online couple intervention adapted from Cognitive-Behavioral Conjoint Therapy for posttraumatic stress disorder (PTSD). It was created to overcome a range of barriers to accessing evidence-based treatments for PTSD and the intimate relationship problems associated with it. This manuscript describes initial outcomes of the intervention in a series of 10 couples. Participants were military, veteran and first responders with probable PTSD and their intimate partners. Couples completed the program and measurements of PTSD, relationship satisfaction, and secondary outcomes at pre-, mid-, and post-intervention. Mean satisfaction for the program was high and it was completed by seven of ten couples. Participants with PTSD evidenced significant and large pre- to post-intervention effect size improvements in PTSD symptoms (g = 0.80) and perceived health (g = 1.13). They also exhibited non-significant but medium effect size pre- to post-intervention improvements in quality of life (g = 0.62), and depression (g = 0.53), and small effect size pre- to post-intervention improvements in argumentativeness (g = 0.43), anger (g = 0.31), and anxiety (g = 0.31). Partners reported significant and moderate pre- to post-intervention effect size improvements in relationship satisfaction (g = 0.68), and medium but not significant effect size improvements in accommodation of PTSD (g = 0.56). Results provide initial support for the feasibility, acceptability, and efficacy of Couple HOPES for improving PTSD and relationship satisfaction. However, more testing in larger samples, including with randomized controlled designs, is needed.

Revisiting the JOQUER trial: stratification of primary Sjögren's syndrome and the clinical and interferon response to hydroxychloroquine.

To re-analyse the clinical outcomes and interferon (IFN) activity data from the JOQUER trial, a phase III trial investigating hydroxychloroquine (HCQ) in patients with primary Sjögren's syndrome (pSS), after stratifying patients into putative pathobiological subgroups utilizing the Newcastle Sjögren's Stratification Tool (NSST) based on patient-reported symptoms of dryness, pain, fatigue, anxiety and depression. 107 patients were assigned to one of four subgroups using NSST at baseline-the high symptom burden (HSB), pain dominant with fatigue (PDF), dryness dominant with fatigue (DDF) and low symptom burden (LSB). Endpoints were re-analysed after stratification, testing for treatment differences within subgroups and adjusting for baseline differences using a repeated measures covariate model. The HSB subgroup (n = 32) showed a relative improvement in ESSPRI of 1.49 points (95% CI 0.54-2.43; p = 0.002) within 12 weeks in patients taking HCQ compared to placebo, with no further changes after 24 weeks. For the LSB subgroup (n = 14), the ESSPRI worsened in the placebo but not the HCQ arm after 12 weeks (mean difference 1.44, 95% CI 0.05-2.83, p = 0.042). Neither the HSB nor the LSB patients showed significant changes in IFN activity at 24 weeks. There were no significant differences in ESSPRI in the PDF (n = 39) and DDF (n = 22) patients taking HCQ. However, significant reductions in overall IFN score at 24 weeks were seen in both PDF (difference at 24 weeks; 6.41, 95% CI, 2.48-10.34, p = 0.002) and DDF (difference at 24 weeks; 7.23, 95% CI, 1.85-12.6, p = 0.009) without improvement in ESSPRI. Although the JOQUER trial reported no overall benefit from HCQ in pSS patients, stratification suggests that both HSB and LSB subgroups may respond to HCQ. However, these patients may benefit through mechanisms other than the reduction of IFN activities.

Fit for purpose? A cross-sectional study to evaluate the acceptability and usability of HeadUp, a novel neck support collar for neurological neck weakness.

The HeadUp collar (previously known as the Sheffield Support Snood) provides support for neck weakness caused by amyotrophic lateral sclerosis (ALS) and has shown to be superior to alternative options in a small cohort of patients from one single center. Here we report the assessment of the HeadUp collar in a larger cohort of patients, exploring the use in other neurological conditions and expanding to other centers across the UK and Ireland. An interventional cross-sectional study design was implemented to investigate the usability and acceptability of the HeadUp collar. A total of 139 patients were recruited for the study, 117 patients had a diagnosis of ALS and 22 patients presented with neck weakness due to other neurological conditions. Participants were assessed at baseline, fitted a HeadUp collar and followed-up one month later. The performance of the HeadUp collar was rated favorably compared to previously worn collars in terms of the ability to eat, drink and swallow. Findings suggest that the collar also permitted a more acceptable range of head movements whilst maintaining a good level of support. We conclude that the HeadUp collar is a suitable option for patients with neck weakness due to ALS and other neurological conditions.

Minimum Electromyographic Burst Duration in Healthy Controls: Implications for Electrodiagnosis in Movement Disorders.

BACKGROUND: Electromyogram (EMG) burst duration can provide additional diagnostic information when investigating hyperkinetic movement disorders, particularly when a functional movement disorder is suspected. It is generally accepted that EMG bursts <50 milliseconds are pathological. OBJECTIVE: To reassess minimum physiological EMG burst duration. METHODS: Surface EMG was recorded from face, trunk, and limb muscles in controls (n = 60; ages 19-85). Participants were instructed to generate the briefest possible ballistic movements involving each muscle (40 repetitions) or, in muscles spanning joints, to generate rapid rhythmic alternating movements (20-30 seconds), or both. RESULTS: We found no effect of age on EMG burst duration. However, EMG burst duration varied significantly between body regions. Rhythmic EMG bursts were shorter than ballistic bursts but only significantly so for lower limbs (P < 0.001). EMG bursts of duration <50 milliseconds were frequently observed, particularly in appendicular muscles. CONCLUSION: We present normal reference data for minimum EMG burst duration, which may assist clinical interpretation when investigating hyperkinetic movement disorders.

Inclusion of people of color in psychedelic-assisted psychotherapy: a review of the literature.

BACKGROUND: Despite renewed interest in studying the safety and efficacy of psychedelic-assisted psychotherapy for the treatment of psychological disorders, the enrollment of racially diverse participants and the unique presentation of psychopathology in this population has not been a focus of this potentially ground-breaking area of research. In 1993, the United States National Institutes of Health issued a mandate that funded research must include participants of color and proposals must include methods for achieving diverse samples. METHODS: A methodological search of psychedelic studies from 1993 to 2017 was conducted to evaluate ethnoracial differences in inclusion and effective methods of recruiting peopple of color. RESULTS: Of the 18 studies that met full criteria (n = 282 participants), 82.3% of the participants were non-Hispanic White, 2.5% were African-American, 2.1% were of Latino origin, 1.8% were of Asian origin, 4.6% were of indigenous origin, 4.6% were of mixed race, 1.8% identified their race as "other," and the ethnicity of 8.2% of participants was unknown. There were no significant differences in recruitment methodologies between those studies that had higher (> 20%) rates of inclusion. CONCLUSIONS: As minorities are greatly underrepresented in psychedelic medicine studies, reported treatment outcomes may not generalize to all ethnic and cultural groups. Inclusion of minorities in futures studies and improved recruitment strategies are necessary to better understand the efficacy of psychedelic-assisted psychotherapy in people of color and provide all with equal opportunities for involvement in this potentially promising treatment paradigm.