200 Participants Needed

Dynamic Neural Retraining System for Chronic Fatigue Syndrome

(MILES Trial)

Recruiting at 3 trial locations
MR
Overseen ByMILES RCT team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mind-body program called the Dynamic Neural Retraining System (DNRS) to determine its effectiveness for individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long COVID. The researchers aim to assess whether DNRS can enhance quality of life, reduce fatigue and pain, and improve mental health and physical activity. Participants will be divided into two groups: one will engage in the DNRS program, while the other will continue their regular treatment plan before eventually switching to DNRS. This study suits those diagnosed with ME/CFS for more than six months, who are well enough to participate, and have reliable internet access. As an unphased trial, it offers a unique opportunity to explore a novel approach to managing ME/CFS and Long COVID symptoms.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot start any new treatments, including prescription or over-the-counter medications, during the study period.

What prior data suggests that the Dynamic Neural Retraining System is safe for people with ME/CFS and Long COVID?

Research has shown that mind-body methods, such as the Dynamic Neural Retraining System (DNRS), are generally well-received. DNRS uses brain exercises, visualization, and mindfulness to help manage symptoms of conditions like chronic fatigue syndrome. These techniques aim to change how the brain and body communicate, potentially improving health and well-being.

Regarding safety, strong scientific evidence specifically about DNRS is lacking. However, mind-body programs do not involve surgery or drugs, often resulting in fewer side effects than medications. As this study is in an early stage, safety data specifically for DNRS remains limited. Nonetheless, because DNRS does not use drugs, it is likely safe with minimal risks. Participants should discuss any concerns or side effects with the study team during the trial.12345

Why are researchers excited about this trial?

Researchers are excited about the Dynamic Neural Retraining System (DNRS) because it offers a novel approach to managing Chronic Fatigue Syndrome (CFS). Unlike traditional treatments that often focus on symptom management through medications like antivirals or cognitive behavioral therapy, DNRS aims to address the underlying neural pathways contributing to chronic fatigue. This system uses brain retraining techniques to potentially rewire neural circuits, promoting a more sustainable recovery. By targeting the brain's plasticity, DNRS could offer a transformative solution for those who haven't found relief with existing options.

What evidence suggests that the Dynamic Neural Retraining System might be an effective treatment for ME/CFS?

Research has shown that mind-body techniques, such as the Dynamic Neural Retraining System (DNRS), may assist individuals with Chronic Fatigue Syndrome (CFS) and similar conditions. These techniques can improve anxiety, tiredness, depression, quality of life, and physical abilities. DNRS leverages the brain's ability to change, known as neuroplasticity, to potentially enhance health. Some studies have reported significant health improvements in patients with similar chronic illnesses. However, strong evidence specifically for DNRS in ME/CFS is not yet available. This ongoing study will help determine its effectiveness, with participants either receiving the DNRS intervention or joining a wait-list control group.23678

Who Is on the Research Team?

ES

Eleanor Stein, MD FRCPC

Principal Investigator

University of Calgary

SV

Sunita Vohra, MD MSc FRCPC FCAHS

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) or Long COVID, experiencing symptoms like muscle pain and fatigue. Participants should be interested in a mind-body treatment approach.

Inclusion Criteria

I have been diagnosed with ME/CFS for over six months.

Exclusion Criteria

Individuals who lack reliable internet
Individuals who are participating in a concurrent study
I have or had inflammatory bowel disease.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the DNRS intervention group undergo the mind-body program, while the wait-list control group continues usual care for 4 months

16 weeks

Follow-up

Participants are monitored for changes in physical functioning and other health-related outcomes post-intervention

4 weeks

Open-label extension (optional)

Wait-list control group participants may opt into the DNRS program after the initial 4-month waiting period

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dynamic Neural Retraining System
Trial Overview The study tests the Dynamic Neural Retraining System™ (DNRS™), a mind-body program aimed at improving health and well-being by leveraging neuroplasticity to potentially alleviate ME/CFS and Long COVID symptoms.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: DNRS intervention groupExperimental Treatment1 Intervention
Group II: Wait-list control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

College of Physicians and Surgeons of Alberta

Collaborator

Citations

Does Brain Retraining Work for Chronic Fatigue Syndrome?Many CFS patients find themselves caught in cycles of temporary improvement followed by relapse, as treatments target downstream effects rather ...
Dynamic Neural Retraining SystemThe program is an effective treatment for chemical sensitivities, chronic fatigue syndrome, fibromyalgia and many other chronic illnesses.
Ongoing ResearchMcMaster University: observational study shows significant improvement in health outcomes. “Neuroplasticity-based treatment for fibromyalgia, chronic ...
Systematic Review of Mind-Body Interventions to Treat ...There are some promising results to improve anxiety, fatigue, depression, quality of life, and physical functioning [28,29,30,31,32] in ME/CFS. In this ...
Dynamic Neural Retraining System for Chronic Fatigue ...We are studying the effect of a mind-body treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID ...
Trial By Error: What Is the Dynamic Neural Retraining ...DNRS is described as a drug-free, step-by-step, intensive limbic rehabilitation program that is based on neuroplasticity therapy.
Chronic Fatigue SyndromeDNRS works by teaching individuals how to rewire their neural pathways through daily brain exercises, visualization, and mindfulness techniques.
Top Chronic Fatigue Syndrome Clinical Trials | PowerThis study explores a mind-body program called the Dynamic Neural Retraining System™, or DNRS™. Mind-body interventions (MBIs) focus on how the brain, mind, ...
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