Large US trial to test online programs for treating MS fatigue

A large clinical trial to test online programs for treating fatigue in people with multiple sclerosis (MS) will launch in the U.S. in the coming months.

The study — the largest of its kind — will be funded by a nearly $4.5-million grant from the U.S. Department of Defense via the MS Research Program and spearheaded by iConquer MS, a patient-powered research initiative from the Accelerated Cure Project (ACP), in collaboration with the U.S. Department of Veterans Affairs (VA).

Recruitment is expected to open this summer within the iConquerMS network and in the fall for five participating VA sites. The study seeks to recruit patients from a wide variety of backgrounds, including communities who are typically underrepresented in clinical trials.

“Fatigue is often the most difficult symptom to manage and the community of people with MS is particularly excited to know this study may provide compelling evidence for a non-pharmacological treatment accessible to everyone,” Laura Kolaczkowski, lead patient representative for iConquerMS, said in a press release.

“We look forward to testing these online programs through a highly inclusive clinical trial to determine if this will be a successful fatigue treatment option,” she added.

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Fatigue is common complaint of MS patients

Fatigue — a mental or physical exhaustion that gets in the way of daily life — is a common complaint in MS. It can arise as a direct consequence of nerve cell damage, or can be secondary to MS treatments, other MS symptoms, or the stress of living with a chronic disease.

Medications have shown a limited ability to ease fatigue in MS patients, and also carry a risk of side effects, so there’s a need to identify effective non-pharmacological interventions that can help reduce the symptom.

Online programs, also called digital therapeutics, offer a potential way to do so. The general idea of such programs is to provide information that helps MS patients understand fatigue and the strategies they can use to manage it. These types of programs, which can be completed at home, also offer a way to reach populations who don’t have easy access to a clinic for care.

“Fatigue can be very debilitating for many people with MS, so finding therapies to manage this symptom is critical,” said Robert McBurney, PhD, ACP’s chief research officer and the study’s co-lead investigator.

“Non-pharmacological, scalable treatments could be life-changing for many people with MS, especially those who live in rural communities or experience other barriers to more invasive medical treatments or in-person sessions,” McBurney added.

Digital therapy company Gaia has developed such a program called Elevida, which is already approved in Germany and covered by health insurance there. It’s essentially an interactive guided therapy program based on cognitive behavioral approaches such as mindfulness that patients move through at their own pace.

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MS patients in German trial report online program reduced their fatigue

A clinical trial conducted in Germany involving 275 MS patients found the online program significantly reduced measures of fatigue and did not cause any safety concerns.

The planned U.S. trial will test the effectiveness of two different online programs, one of which is an American English version of the German one. Gaia and other institutions involved in the development of the German version will be collaborators on the U.S. project. Ultimately, the goal is to earn a similar approval from the U.S. Food and Drug Administration for such a program as a therapy for MS fatigue.

The large clinical trial is expected to enroll 2,000 MS patients. The range of sites selected through the iConquer MS and VA networks is to ensure that patients from typically under-represented populations are also included in the studies.

Participants will be assigned to use either of the two experimental online programs, or no online program, for six months on top of their standard MS medications, with a final study visit six months after that (one year total). In the second six-month period, participants not initially assigned to an online program will be able to choose one to participate in.

“We hope this largest-ever and most-diverse clinical trial of online treatments for fatigue in MS will definitively demonstrate the benefits [of this online therapeutic] for people with MS from a wide variety of backgrounds,” McBurney said.