Tag: Multiple Sclerosis

Prevalence and Patterns of Marijuana Use among Patients Diagnosed with Multiple Sclerosis

Title:Prevalence and Patterns of Marijuana Use among Patients Diagnosed with Multiple Sclerosis
Status:Completed
Topic:Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source:State of Connecticut: Biomedical Research Trust Fund
Funding Period:2018-2019
Study Design:Qualitative research survey
Purpose:The PRC collaborated on this study with neurologist Joseph Guarnaccia, MD of the Multiple Sclerosis Treatment Center (MSTC) at Griffin Hospital. The goal was to better understand the use of marijuana by people who have been diagnosed with multiple sclerosis (MS) through the use of a cross-sectional survey. The results could provide valuable information for clinicians who currently refer their patients with MS to medical marijuana programs, have considered referring them, or have been reluctant to refer them. The study data could also be useful in setting new research agendas and tailoring health policies on the use of medical marijuana as a therapy or adjuvant therapy in managing patients with MS.
Further Study Details:The study team developed a 36-question survey that was estimated to take 10 to 15 minutes to complete. It was made available to be completed either as paper version of the survey, or as an online version available through an encrypted link. The survey elicited demographic data from survey respondents, including their age, gender, education level, employment status, household composition, type of MS, and degree of disability. It also included questions regarding: their patterns of marijuana use; their use of prescription medications, including opioid and benzodiazepines, tobacco products, and alcohol; their MS symptoms; and the perceived benefits and/or adverse effects of their medical marijuana use.  An invitation to complete the survey was sent to 317 adults with MS, most of whom were patients at the MSTC at Griffin Hospital.
Findings:A total of 115 surveys were completed and included in the analysis. Respondents were predominantly female (73.0%). The majority (72.2%) had relapsing and remitting MS. Most (63.5%) were on at least 3 prescription medications for MS. The use of medical marijuana more than once a day was associated with reported improvement of at least two of their MS-related symptoms. Although medical marijuana use was reportedly associated with feeling slightly “high” by the survey respondents, they felt that medical marijuana use was more effective than other MS medications.
Eligibility:Multiple sclerosis patients from the MSTC who are enrolled in the State of Connecticut’s Medical Marijuana (CTMMP) Program
Changed at:3/27/2020 3:45 PMChanged by:
Created at:11/27/2018 9:40 AMCreated by:Lisa Seaberg

A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

Title:A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
Status:Completed
Topic:Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source:State of Connecticut: Biomedical Research Trust Fund
Funding Period:2016-2020
Study Design:Randomized controlled trial
Purpose:The purpose of this study was to examine whether mindfulness meditation would be more effective than standard sleep hygiene counseling in treating insomnia and improving quality of life in MS patients. Many MS patients suffer from chronic insomnia, leading to daytime impairment. Pharmacological treatments for MS may also contribute to insomnia, and may have adverse side effects. A potential alternative treatment involves mindfulness – focusing one’s attention on the present moment without judgment. Mindfulness is hypothesized to increase the ability to tolerate, thoughts and emotions, which in turn can reduce perceptions of stress, anxiety, and pain. Prior research has shown some benefits of mindfulness in treating insomnia in general, and some benefits of stress reduction techniques in managing MS-related insomnia.
Further Study Details:Each participant was randomly assigned to one of two groups. One group attended 10 weekly sessions of mindfulness-based training for insomnia. The other group attended a single group session on sleep hygiene. During the study, members of both groups wore Fitbit devices each day for several weeks to record their sleep data. At two study time points, they completed a set of questionnaires and visited the PRC for clinical assessments.Study outcome measures included sleep efficency using collected from Fitbit Charge 2 devices; self-reported sleep quality (Pittsburgh Sleep Quality Index); self-reported insomnia (Insomnia Severity Index); self-reported quality of life (MS Quality of Life Inventory, and self-reported quality of life (MS Quality of Life Inventory, a set of questionnaires to measure self-reported overall health status, fatigue, pain, sexual satisfaction, bladder control, bowel control, visual impairment, cognitive dysfunction, mental health, and social support). Participants were also monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events.
Findings:Mindfulness training led to significant improvements in self-reported sleep quality, insomnia severity, fatigue, cognitive function and mental health, which were all secondary outcome measures. It did not lead to a significant improvement in sleep efficiency, which was the primary outcome measure.
Eligibility:Men and women age 18 years or older diagnosed with MS, and with a history of chronic insomnia, but no known history of obstructive sleep apnea or narcolepsy.
Evaluation:Study outcome measures included objective sleep quality (using data collected from Fitbit Charge 2 devices); self-reported sleep quality (Pittsburgh Sleep Quality Index); self-reported insomnia (Insomnia Severity Index); self-reported quality of life (MS Quality of Life Inventory). Participants were also monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events.
Changed at:4/12/2023 4:40 PMChanged by:Christian Meagher
Created at:11/30/2017 5:24 AMCreated by:Lisa Seaberg

COVID-19 Booster Vaccination in Persons with Multiple Sclerosis

Title:COVID-19 Booster Vaccination in Persons with Multiple Sclerosis
Status:Current
Topic:Multiple Sclerosis;COVID-19 Vaccine
Funding Source:The Connecticut Department of Public Health’s Biomedical Research Trust Fund
Funding Period:2021-2022
Study Design:Prospective, randomized study
Purpose:Certain medications prescribed to persons with multiple sclerosis (MS) may suppress their immune systems and reduce the effectiveness of vaccines. This study will test whether adding a booster dose of one of three currently available COVID-19 vaccines to persons with MS on immune-suppressive medications can improve their immune response to COVID-19. Two of the vaccines (Pfizer and Moderna) are mRNA vaccines, while the third (Johnson & Johnson) is a DNA vaccine.This study is designed to:determine immune response by testing for the spike protein antibodies to COVID-19 after receiving a booster of either an mRNA or a DNA vaccine;test whether receiving the same vs. different type of vaccine for a booster – relative to the type of vaccine received initially – is more likely to produce an immune response;test whether certain MS medications are more or less likely to affect response to a booster vaccine;test whether the levels of lymphocytes (T or B cells) and total antibodies affect the likelihood of a response to a booster vaccine.
Further Study Details:Study participants will be randomized to receive a booster dose of either a homologous vaccine or a heterologous vaccine. This means the Johnson & Johnson vaccine if they originally received the Pfizer or Moderna vaccine, or vice versa.At the first visit, participants will provide information on their medication history and course of their MS, undergo a neurological evaluation, have a blood sample taken, and receive a booster vaccination. At the second visit 4 to 6 weeks later, they will respond to questions regarding their booster vaccine experience and state of their MS, and will have a blood sample taken.
Eligibility:We plan to enroll up to 60 adults with MS. They must meet the following criteria:have completed an initial course of one of the three vaccines (Pfizer, Moderna, or Johnson & Johnson);have tested negative for CovID-19 spike protein antibodies after vaccination;are willing to receive one of the three available vaccines as a one-shot booster;women of child-bearing potential must not be pregnant.
Evaluation:Outcome measures include: • percentage of participants who test positive for COVID-19 spike protein antibodies following a booster vaccination; • comparison of percentage of participants who test positive for COVID-19 specific spike protein antibodies between those who receive homologous vs. heterologous boosters. from baseline; • comparison of percentage of participants who test positive for COVID-19 spike protein antibodies based on disease modifying treatment; • correlation of COVID-19 spike antibody presence and levels based on B and T cell subsets and overall immune globulin levels.
Changed at:12/21/2021 12:54 PMChanged by:
Created at:12/21/2021 12:44 PMCreated by:

A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis

Title:A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis
Status:Current
Topic:Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source:State of Connecticut: Biomedical Research Trust Fund
Funding Period:2018-2023
Study Design:Investigational pilot study
Purpose:This study will examine whether changing the bacteria in the gut through a fecal microbial transplant (FMT) can affect the autoimmune process that leads to the development of multiple sclerosis (MS). Using oral capsules approved by the Food and Drug Administration (FDA) for other uses, we will transfer fecal material from healthy persons to persons with MS. The FDA has granted permission for this investigational pilot study.
Further Study Details:The PRC is conducting this study in collaboration with neurologist Joseph Guarnaccia, MD of the Multiple Sclerosis Treatment Center (MSTC) at Griffin Hospital, who is the principal investigator.Each participant will make 8 visits to Griffin Hospital in Derby, CT. These will include: a clinical screening; a single procedure of 30 FMT capsules taken by mouth; and 5 other visits for blood and stool samples, medical exams, and surveys. FMT capsules and all study procedures and tests will be provided free of charge.
Eligibility:Study participants must: (1) be 18 to 55 years of age; (2) have been clinically diagnosed as having MS; (3) be able to walk with without stopping to rest for up to 100 meters (about 300 feet) or able to walk 20 meters (about 60 feet) without stopping to rest while using 2 canes, 2 crutches, or a walker; (4) not be on immunotherapy (except for interferon beta or glatiramer acetate); and (5) be willing to visit Griffin Hospital 8 times over a 4-month period.
Evaluation:The study team will measure the following: (1) ability to tolerate FMT capsules without vomiting or adverse side effects; (2) changes in immune markers found in blood samples; (3) changes in microbiome of stool samples; (4) changes in self-reported quality of life, mental health status, and levels of fatigue; and (5) changes in MS disease status.
Changed at:4/12/2023 4:16 PMChanged by:Christian Meagher
Created at:3/27/2020 2:56 PMCreated by: