An interventional study of Eight weekly 90-minute group educational sessions in Multiple Sclerosis, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Supportive care
Among 1,192 studies in Multiple Sclerosis with a site in United States — 184 open to participants now, 260 under way, 23 of them phase 3. Multiple Sclerosis · United States.
Among the 1,192 studies in Multiple Sclerosis with a site in United States, this one is the 721st largest by enrollment of the 879 interventional ones that give a count, is one of 60 that started in 2017, is one of 381 with no phase, and was the 630th registered.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
Browse Multiple Sclerosis studies →184 of the 1,192 studies in Multiple Sclerosis with a site in United States are open now. Recruiting first, the newest first:
Sundance Biosciences, Inc. · Sites in United States
Genentech, Inc. · Sites in United States, Puerto Rico
The University of Texas Health Science Center, Houston · Sites in United States
Washington University School of Medicine · Sites in United States
University of Texas at Austin · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 21 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,192 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 142 · Phase 2 191 · Phase 3 142 · Phase 4 82
First in 1976; this study’s year is marked. 60 started in 2017.
This study's enrollment of 16 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Median enrollment 50 across the 879 interventional studies, 100 across the 302 observational. Of the 817 that completed or were terminated, 331 (41%) have results posted.
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376 of 1,192 have an industry lead sponsor. The 10 most frequent:
University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
University of Texas at Austin has 6 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
79 of the studies in Multiple Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05134441Phase 3Immunic AGStudy to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis | 2026-11 |
| NCT06847724Phase 3SandozComparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis | 2026-11 |
| NCT05877963Phase 3TG Therapeutics, Inc.Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab | 2027-01-21 |
| NCT06136728Phase 3MGH Institute of Health ProfessionsDalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis | 2027-05 |
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
Among the 1,192 studies in Multiple Sclerosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Development and pilot testing of a cognitive self-management intervention for persons with multiple sclerosis (PwMS) emphasizing physical activity (PA) delivered via web-based video conference.
The primary objective of this study is to develop and pilot test an innovative cognitive self-management intervention for PwMS delivered via web-based video conferencing. Data derived from interviews will be used to guide the adaptation of Stuifbergen's 8-week Memory, Attention, and Problem-Solving Skills in MS (MAPSS-MS) intervention to be delivered via web-based video conferencing. The adapted MAPSS-MS intervention will be feasibility tested in small groups of PwMS. Outcome variables include: (1) neurocognitive function assessed using the NIH Toolbox®, a comprehensive set of psychometrically sound neuro-behavioral measures that quickly assesses cognitive functions using an iPad, (2) objective PA and sleep using Actigraph™ accelerometers, (3) self-reported sleep, depression, and fatigue using the Patient-Reported Outcome Measurement Information System (PROMIS), and (4) MS specific self-management using the Multiple Sclerosis Self-Management Scale (MSSM). Community-residing PwMS, age 21 to 70, will be recruited from Central Texas to participate in Phase 1 interviews (n=5) and Phase 2 pilot testing (n=20) of the adapted version of the 8-week MAPSS-MS cognitive self-management intervention emphasizing PA delivered via web-based video conferencing. In Phase 2 pilot testing (n=20), an intervention group (n=10) will be compared to an "enhanced usual care" control group (n=10).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Eight weekly 90-minute group educational sessions attended via a computer, tablet, or smart phone using a web-based video conference platform.
Behavioral: Eight weekly 90-minute group educational sessions
Enhanced usual care control group will receive an illustrated instructional booklet on Physical Activity for persons with MS developed by the National Center on Health, Physical Activity and Disability (NCHPAD).
Eight weekly 90-minute group educational sessions, originally developed for the MAPSS-MS intervention, adapted for remote web-based delivery.
Change from Baseline NIH Toolbox Picture Vocabulary Test at 8-weeks (post-intervention)
Test of vocabulary knowledge
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox Oral Reading Recognition at 8-weeks (post-intervention)
Test of oral reading (decoding) skills
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox Flanker Inhibitory Control and Attention Test at 8-weeks (post-intervention)
Test of executive function - the capacity to plan, organize and monitor the execution of behaviors that are strategically directed in a goal-oriented manner) and attention (allocation of one's limited capacities to deal with an abundance of environmental stimulation) test.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox Dimensional Change Card Sort Test at 8-weeks (post-intervention)
Test of attention - the allocation of one's limited capacities to deal with an abundance of environmental stimulation) test.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox List Sorting Working Memory Test at 8-weeks (post-intervention)
Test of working memory - the capacity of an individual to hold information in a short-term buffer and manipulate the information.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox Oral Symbol Digit Test at 8-weeks (post-intervention)
Test of processing speed - the amount of time it takes to mentally process a set amount of information, or the amount of information that can be processed within a certain unit of time. It is a measure that reflects mental efficiency.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox Pattern Comparison Processing Speed Test at 8-weeks (post-intervention)
Test of processing speed - the amount of time it takes to mentally process a set amount of information, or the amount of information that can be processed within a certain unit of time. It is a measure that reflects mental efficiency.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline NIH Toolbox Picture Sequence Memory Test at 8-weeks (post-intervention)
Test of episodic memory - the acquisition, storage and retrieval of new information. It involves conscious recollection of information learned within a context.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Multiple Sclerosis Self-Management Scale (MSSM) at 8-weeks (post-intervention)
A 24-item self-report instrument developed specifically to address self-management in persons with MS.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Medications and Treatments 4a at 8-weeks (post-intervention)
A 4-item self-report measure of confidence in managing medication schedules of different complexity. Items also assess managing medication and other treatments in challenging situations such as when traveling, when running out of medication, and when adverse effects are encountered.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a at 8-weeks (post-intervention)
A 4-item self-report measure of confidence to manage/control symptoms, to manage symptoms in different settings (home, public place, an unfamiliar place) and to keep symptoms from interfering with work, sleep, relationships or recreational activities.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a at 8-weeks (post-intervention)
A 4-item self-report measure of confidence in performing various activities of daily living (ADLs) without assistance. Items also assess exercise, sexual activities and managing activities in challenging situations (traveling, bad weather).
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-Quality of Life (QoL) Short Form v2.0 - Cognitive Function at 8-weeks (post-intervention)
An 8-item self-report measure of mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-QoL Short Form v1.0 - Depression at 8-weeks (post-intervention)
An 8-item self-report measure of negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included, which eliminates consideration of these items' confounding effects when assessing patients with comorbid physical conditions. Assesses depression over the past seven days.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-QoL Short Form v1.0 - Fatigue at 8-weeks (post-intervention)
An 8-item self-report measure of fatigue symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Assesses fatigue over the past seven days.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Neuro-QoL Short Form v1.0 - Sleep Disturbance 4a at 8-weeks (post-intervention)
An 8-item self-report measure of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep). Assesses sleep disturbance over the past seven days.
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Physical Activity - steps at 8-weeks (post-intervention)
Accelerometer step count
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Physical Activity - activity count at 8-weeks (post-intervention)
Accelerometer activity count
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - sleep latency at 8-weeks (post-intervention)
Accelerometer sleep latency
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - wake after sleep onset at 8-weeks (post-intervention)
Accelerometer wake after sleep onset
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - total sleep time at 8-weeks (post-intervention)
Accelerometer total sleep time
Time frame: Baseline and 8-weeks (post intervention)
Change from Baseline Sleep quality - sleep efficiency at 8-weeks (post-intervention)
Accelerometer sleep efficiency
Time frame: Baseline and 8-weeks (post intervention)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to share individual participant data from this pilot study
Ran from Oct 2017 to primary completion in Jun 2018, 7 months.
Of 847 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 7 months is below that.
Counting every sponsor, half of 869 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of Texas at Austin →