Current Enrolling Clinical Trials

Transcription

1 High-dose immunosuppressive therapy followed by autologous hematopoietic cell transplantation for highly selective MS, NMO patients or patients with other autoimmune neurological diseases failing standard therapies Recruitment Period Open to enrollment Fred Hutchinson / University of Washington Providers feeling that they may have a possibly suitable candidate may consider contacting one of investigators or refer patients to study coordinators listed below. This study is not advertised for broadly. PI: George Georges FHCRC Collaborators: Annette Wundes, MD, James Bowen, MD, George Kraft, MD Bernie McLaughlin, bmclaugh@fhcrc.org; Christine Kane, ckane@fhcrc.org Patient s insurance Description of Study/Trial: Stem cell transplantation for selected patients with MS, NMO or other neurological autoimmune diseases not stabilized under other treatments. Short-version of eligibility criteria: MS: Patient with definite MS diagnosis of MS Relapsing MS or SPMS Two or more relapses (clinical and/or MRI) within last 2 years EDSS progression of at least 1 point within last 2 years Relapses or progression while on standard DMT Failure of at least 2 DMTs taking for 6+ months NMO: Definite dx of NMO per 2006 criteria EDSS progression Disease progression with at least 2 standard DMT agents

2 MindTOPS Recruitment Period Present thru February 28, 2015 UW Medicine MS Center, HMC Adults 18 years of age or older; have a diagnosis of MS; experience moderate to severe chronic pain on a regular basis; and are able to read, speak and understand English. Dawn Ehde Ph.D , mindtops@uw.edu National Multiple Sclerosis Society Description of Study/Trial: Aim is to conduct a pilot (N = 30) RCT comparing mindfulness based cognitive therapy with cognitive therapy for pain in people with MS. We propose to have around 30 subjects with MS and chronic pain complete the study. Subjects will be recruited from a variety of sources including a departmental registry or subject pool, ongoing survey studies, and University of Washington Medical Center (UWMC)/Harborview Medical Center (HMC) clinics. During the initial intake session and post-treatment session, subjects will be asked to complete a set of tasks testing memory, provide information about themselves, their diagnosis, and pain problem(s) they experience. Additionally, subjects will be asked questions about pain intensity, different locations of pain, any depressive symptoms, and questions about how they think about pain. Subjects will also complete daily diaries on the internet regarding pain intensity and how they think about pain. Once a week online assessments will be completed as well. Subjects then will be randomly assigned to receive eight sessions of one of two treatments: (1) cognitive therapy (CT) or (2) mindfulness based cognitive therapy (MBCT).

3 Project Enhance Recruitment Period May 2014 thru May 2016 UWMC, Senior Services of King County, Local Senior Centers in King County Adults age 45 and older living with MS and living in the King County area. Ivan Molton, Ph.D , NIDRR Description of Study/Trial: The primary objectives of the current Project II proposal are to partner with a large non-profit community service organization, already delivering an NCOA endorsed intervention to older adults, to test the utility and efficacy of this intervention in people aging with LTPD. The fact that our intervention is already well-established outside of LTPD, and that we will be testing its efficacy as implemented in a real-world setting, puts this project in the scale-up evaluation stage of research. Our primary study outcomes will be (1) satisfaction with treatment, (2) efficacy of the treatment relative to treatment as usual, and (3) equivalence of treatment effects relative to older adults without LTPD diagnoses. Our community partner will be Senior Services, a non-profit agency which is the largest provider of NCOA Highest Tier health promotion programs to older adults in Washington State. Specifically, we will collaborate with Senior Services to test one particular umbrella program for seniors with medical conditions called EnhanceWellness (described in detail later in this proposal). We will use a participatory action research model, involving both consumers and representatives of service agencies, throughout the trial. Following a series of qualitative interviews designed to inform research staff regarding the desirability of, and barriers to, structured wellness promotion interventions in this population, we plan to enroll 120 individuals aging with LTPD in King County, WA in EnhanceWellness, and to monitor key outcomes at baseline and after completion of the program (i.e., 6 months later). A sample of participants will also complete qualitative exit interviews, to assess satisfaction variables not captured via pen-and-paper selfreport. Such an approach, which involves community services agencies in the modification and delivery of an intervention to promote healthy aging in those with LTPD, would be novel and impactful for this population.

4 L.A.N.D Recruitment Period June 2014 thru June 2017 UW MS Center, Swedish, Evergreen Adults 18 years of age or older who have been diagnosed with MS within the past month; and are able to read, speak, and understand English Kevin Alschuler, Ph.D National Multiple Sclerosis Society Description of Study/Trial: This proposal is for a longitudinal assessment of 250 patients with MS at frequent intervals over the first year following diagnosis. We will assess quality of life, depression, pain, fatigue, cognitive difficulties, and other biopsychosocial risk and protective factors at 1, 2, 3, 6, 9, and 12 months after diagnosis. The study will use a trajectory analysis approach that allows for the identification of distinct trajectories of any given outcome, which is an improvement from traditional longitudinal analyses that lump all patients together to define a single pattern that is believed to be applicable to all patients. Through this analytic method, we will be able to assess whether multiple patterns exist for such outcomes as quality of life. In non-ms populations (e.g., cancer, spinal cord injury), trajectory analyses have indicated that there are often multiple common trajectories of quality of life, such that some patients report consistently good quality of life, some report consistently poor quality of life, some initially report poor quality of life but it improves, and some initially report good quality of life and it declines. While we anticipate similar findings in persons with MS, we also recognize that the experience surrounding the diagnosis of MS differs significantly from the sudden onset of commonly-studied populations, such as traumatic injury or cancer, and thus might yield entirely different findings. Finally, the present study will also longitudinally track important symptoms (examples include pain, fatigue, depression, cognitive) to better understand the trajectories of each of those symptoms, as well as to understand the relationship of these symptoms to the trajectories of quality of life. This information has the potential to inform future research on interventions by identifying the significant risk and protective predictors of quality of life in the first year after diagnosis.

5 GET Smart Recruitment Period May 2014 thru May 2017 Exercise training - Northwest Outpatient Medical Center (near Northgate Mall) Study Interviews - University of Washington Medical Center Adults years old with MS diagnosed at least five years ago. Charles Bombardier, Ph.D. Katharine Alexander, Research Assistant, , Toll-Free National Multiple Sclerosis Society Description of Study/Trial: We plan to enroll 125 adults with clinically definite MS into this study during an active recruitment period of 3 years. The study is a two-arm, parallel group RCT comparing two different supervised exercise training programs: aerobic exercise training and stretching & toning training. Each training program will be done up to one-hour per session, three times per week, over six months. The group assignment will be conducted using a central, computer-generated, stratified, blockedrandomization and the ratio will be 1:1 aerobic exercise (n=63) versus stretching & toning (n=62). Randomization will be stratified based on sex. The primary outcome, speed of information processing, will be assessed at baseline, at the end of treatment (6 months) and at follow-up (3-months after treatment), by a trained independent evaluator who is kept unaware of the subject s experimental condition. Secondary outcomes include a neuropsychological test battery designed for people with MS, measures of subjective cognitive impairment, and depressive symptomatology.

6 MS Care Recruitment Period Starting June, UW Medicine MS Center We will be recruiting subjects with: (1) A definitive diagnosis of MS confirmed by participants MS physician in the UW MS Clinic; (2) Patient attends the UW MS Center during enrollment period; (3) Patient reports a clinically significant problem in pain and/or depression, specifically: (a) Chronic Pain: Average pain intensity in the past month of moderate severity (defined as a 3 or greater on 0-10 numeric rating scale)112 and pain of at least six months duration, and reportedly present at least half of the days in the past six months; (b) Depression: Depressive symptoms over the past two weeks in the range of probable major depression on PHQ-9 (10 or higher)126 and endorsement of depressed mood and/or anhedonia (i.e. one of the cardinal symptoms of depression) present at least half the days in the past two weeks; (4) Patient has access to and is able to communicate over the telephone (we will provide phone headsets if needed) to allow participation in the telehealth components of the study; (5) Patient can read and speak English; (6) Patient is at least 18 years of age. Dawn Ehde, Ph. D , mscare@uw.edu PCORI Description of Study/Trial: Participants will either be assigned to collaborative care or treatment as usual for management of depression and/or pain. Collaborative care is a coordinated intervention managed by a care manager for the delivery of guideline-based medical and behavioral treatments. Treatment group: - 16 weeks of weekly phone sessions (<1 hr) that include monitoring of mood and/or pain, and behavioral and psychopharm interventions Control group: Treatment as usual