A Pilot Study of Amygdala Retraining Program (ARP) Versus Control (C) in Patients With Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM)
The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic Fatigue (CF) and Fibromyalgia (FM). CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain, impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to retrain this neuronal network through mind-body practices such as cognitive restructuring via neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A case series of 33 patients with CFS and ARP reported improvement in 92% of patients with two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However ARP has never been formally studied in CFS. We propose to gather preliminary data on the efficacy and feasibility of ARP versus C on fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will undergo standard clinical treatment which consist of a 2 day self-management program in the Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C group. The ARP group will receive an additional 2.5 hour training surrounding core concepts of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months from a study investigator for support. The C group will receive only standard care. However they will receive a complementary copy of the ARP program at the end of the study (6 month time point) as a gift for participation in the study. Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36 (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily practice log where patients record the total time spent daily in the practice of ARP and any specific difficulties they encountered in the practice of the program.
NCT01046370 — Fibromyalgia
Status: Completed
http://inclinicaltrials.com/fibromyalgia/NCT01046370/
Intestinal Microbiota and Chronic Fatigue Syndrome. Effect of Fecal Transplant on Health Related Quality of Life of the Patients With Chronic Fatigue Syndrome
Gut microbiota of 1) patients with chronic fatigue syndrome and 2) their healthy family members are analyzed. Up to 40 patients with chronic fatigue syndrome are randomized to receive either 1) a faecal transplant from a healthty donor or 2) their own feces via colonoscopy. Patient's health related quality and ability to work are assessed (baseline, 1 and 6 months after the procedure)
NCT04158427 — Microbial Colonization
Status: Completed
http://inclinicaltrials.com/microbial-colonization/NCT04158427/
Rapamycin in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
The goal of this observational study is to assess the clinical response and the effect of autophagy function in ME/CFS patients before, during and throughout oral low dose sirolimus (rapamycin) therapy. The main questions this study aims to answer are: - Does rapamycin reduce the overall symptom burden of ME/CFS and does it improve the quality of life? - Does rapamycin change mTOR driven autophagy deficits observed in a subset of ME/CFS patients? Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment. Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy.
NCT06257420 — Myalgic Encephalomyelitis
Status: Enrolling by invitation
http://inclinicaltrials.com/myalgic-encephalomyelitis/NCT06257420/
A Multi-center, Randomized, Double-blind, Positive Parallel Control Study of Compound Xiwujia Granules in the Treatment of Chronic Fatigue Syndrome (Spleen-kidney Deficiency Syndrome, Heart-spleen Deficiency Syndrome)
To observe the improvement of Chalder scale score in patients with chronic fatigue syndrome treated by compound Ciwujia granules. Improvement =[(baseline score - post-treatment score)/baseline score]*100%
NCT06245642 — Chronic Fatigue Syndrome
Status: Not yet recruiting
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT06245642/
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are: - how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface? - how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).
NCT06211062 — IBS - Irritable Bowel Syndrome
Status: Recruiting
http://inclinicaltrials.com/ibs-irritable-bowel-syndrome/NCT06211062/
Exploring Worry in the Context of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Qualitative Study
This study will be building on the findings of Kalfas et al 2022 paper exploring the prevalence of generalised worry in patients with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) before and after Cognitive Behavioural Therapy (CBT). The research was conducted in South London and Maudsley NHS Foundation Trust's (SLaM) Persistent Physical Symptoms Research and Treatment Unit. Previous research has indicated a bidirectional relationship between fatigue and worry (Kalfas et al., 2022); the findings of this paper suggest both that many ME/CFS patients experience comorbid problematic generalised worry and that there is a positive association between severity of worry and levels of fatigue (Kalfas et al, 2022). It appears that CBT for ME/CFS indirectly treats worry, however effect sizes are small to moderate, and treatment outcomes may improve if CBT treatments incorporate strategies that target generalised worry (Kalfas et al 2022). The aims of this project are to further explore worry in this group of patients through qualitative methods.
NCT06011135 — Chronic Fatigue Syndrome
Status: Not yet recruiting
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT06011135/
Assessing Patient Engagement and Understanding in Chronic Fatigue Syndrome Clinical Trials
The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.
NCT05967494 — Chronic Fatigue Syndrome
Status: Not yet recruiting
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT05967494/
Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome
This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome). Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days). There will be 4 outpatient visits to the research center and 12 telephone consultations. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm). Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.
NCT05967052 — Chronic Fatigue Syndrome
Status: Recruiting
http://inclinicaltrials.com/chronic-fatigue-syndrome/NCT05967052/
Extracorporal Apheresis Hannover Medical School Study in Post COVID-19 Patients
The complex clinical symptoms of post COVID syndrome, especially chronic fatigue, pose a major challenge to patients and to the health care system and are frequently refractory to therapeutic intervention. There is increasing evidence that a dysregulated post-viral immune response may be involved in the pathogenesis of post COVID syndrome. In uncontrolled case studies, an improvement of fatigue symptoms after removing autoantibodies has been reported in post COVID patients. However, there is a lack of prospective, sham controlled studies. We initiate an interventional, randomised, sham treatment-controlled prospective study, the EXTINCT post COVID study, which aims to scientifically test the therapeutic efficacy of an extracorporeal apheresis procedure (immunoadsorption) for the treatment of a well characterized cohort of patients with post COVID syndrome, while at the same time providing basic research evidence for an understanding of the pathogenesis of post COVID syndrome. Thereby, we expect to obtain important insights into the diagnosis, treatment and pathophysiology of post-COVID syndrome.
NCT05954325 — Fatigue
Status: Recruiting
http://inclinicaltrials.com/fatigue/NCT05954325/
Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (ME/CFS) Registry and Biobank
Chronic fatigue syndrome (syn. myalgic encephalomyelitis or ME/CFS) is a relatively common, but pathogenetically still insufficiently understood, complex, severe, chronic disease. It has been classified by the WHO as a neurological disorder (ICD-10 G93.3). The leading symptoms are pathological exhaustion (fatigue) and prolonged, inadequate deterioration of condition after exertion (syn. post-exertional malaise or PEM). In addition, pain, sleep disturbances, flu-like symptoms, and cognitive, autonomic, and neuroendocrine symptoms are typically found. In the majority of patients*, the trigger is a viral disease, including infectious mononucleosis caused by Epstein-Barr virus (EBV), which is particularly common in young patients, but also influenza or coronavirus disease 2019 (Covid-19) at any age. Causative factors are discussed to be autoimmune mechanisms as well as a genetic predisposition. The general activity level and quality of life of patients are usually significantly reduced due to the disease. A large proportion of those affected are confined to a wheelchair, home or bed. ME/CFS is one of the most common reasons for long absences from school due to illness. Because no reliable biomarkers are available, ME/CFS is a diagnosis of exclusion. The diagnosis is made using internationally established clinical criteria and after careful differential diagnosis. To date, no causal, but only symptom-oriented, non-standard treatment approaches are found. With appropriate care, the prognosis in childhood and adolescence is better than in adults. Long-term recovery is possible in two-thirds of young patients, whereas less than one-third of adult patients can expect recovery. In Germany, there are currently two special outpatient clinics for patients with ME/CFS, one for adult patients* at the Charité Fatigue Centrum in Berlin, headed by Prof. Scheibenbogen, and one for children, adolescents and young adults up to 25 years of age at the ME/CFS focus of the Children's Polyclinic of the MRI of the TUM in Munich, headed by Prof. Behrends. A joint data collection of these ME/CFS centers has not been established. The proposed ME/CFS registry study (MECFS-R) is intended to initially pool medical data from specialized routine care on a bicenter basis and, after recruitment of additional German centers, on a multicenter, longitudinal, and web-based basis, as extensive as possible, and to make this data available for research. Following the example of already well-established European registry studies (e.g., the ESID registry of the European Society for Immunodeficiencies), digital data acquisition should take place in a tiered approach according to cost-benefit analysis. Medical institutions can decide, based on capacity, whether a clearly defined core data set (level 1) or more complex data sets (level 2 or 3) should be digitally captured. The digital implementation is to be carried out in collaboration with the Munich-based IT company Bitcare, whose database concepts have proven successful in the context of the Transplantation Cohort (Tx Cohort) of the German Center for Infection Research (DZIF) or the Covid-19 study of the MRI of TUM (COMRI) and with whom the team at the MRI of TUM has been working successfully for many years. The aim of the MECFS-R is to accurately describe the clinical picture and its course in Germany clinically and epidemiologically as well as to derive epidemiological or medical risk factors, if applicable, and to define subcohorts for future treatment approaches.
NCT05778006 — SARS CoV 2 Infection
Status: Recruiting
http://inclinicaltrials.com/sars-cov-2-infection/NCT05778006/