Dynamic Neural Retraining System for Chronic Fatigue Syndrome
(MILES Trial)
Trial Summary
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.
How does the Dynamic Neural Retraining System treatment differ from other treatments for chronic fatigue syndrome?
The Dynamic Neural Retraining System is unique because it focuses on retraining the brain's neural pathways to address chronic fatigue syndrome, unlike other treatments that may focus on symptom management or medication. This approach is novel as it targets the brain's ability to change and adapt, potentially addressing the root cause of the condition rather than just alleviating symptoms.12345
What is the purpose of this trial?
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 (LC). Our team recognizes that ME/CFS and Long COVID are serious, debilitating, biomedical conditions.ME/CFS can affect many different parts of the body, such as the nervous system, immune system, and metabolism. It is hypothesized that central sensitization (i.e., when nerves get too excited) may influence these complex conditions and may make symptoms worse.This study explores a mind-body program called the Dynamic Neural Retraining System™, or DNRS™.Mind-body interventions (MBIs) focus on how the brain, mind, body, and behaviour interact to improve health and well-being. These techniques help people become more aware of themselves, take better care of their health, and boost mood, quality of life, and coping skills. MBIs use the brain's ability to change (neuroplasticity) by reinforcing certain thoughts, feelings, or behaviours that support changes in biology and function. MBIs may influence physical health by affecting how the brain and body communicate through chemicals such as hormones and neurotransmitters. Objective fMRI evidence shows that practising MBIs can change brain structure and function. This makes MBIs a potential good fit for people with chronic illnesses like ME/CFS and LC, which involve complex interactions between the brain, immune system, and hormones.There is no rigorous peer-reviewed evidence that DNRS is effective. Our study will address this question using subjective and objective measurements in a multiple-methods wait-list randomized controlled trial.The objectives of this study are to: 1) examine the effectiveness of the DNRS program for individuals diagnosed with ME/CFS with and without Long COVID, compared to a treatment-as-usual wait-list control group on a range of patient-reported outcomes including health-related quality of life, fatigue, pain, anxiety and depression and objective measures including daily steps, heart rate variability, and sleep; 2) quantify metabolic changes through untargeted serum metabolomics profiling, 3) determine if metabolomics screening can predict treatment responsiveness to DNRS; and 4) identify the microbial signatures of large bowel microbiota in Long COVID patients pre and post MBI.A descriptive qualitative study will also be conducted in a sample of participants to learn more about their experiences during the trial.
Research Team
Sunita Vohra, MD MSc FRCPC FCAHS
Principal Investigator
University of Alberta
Eleanor Stein, MD FRCPC
Principal Investigator
University of Calgary
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the DNRS intervention group undergo the mind-body program, while the wait-list control group continues usual care for 4 months
Follow-up
Participants are monitored for changes in physical functioning and other health-related outcomes post-intervention
Open-label extension (optional)
Wait-list control group participants may opt into the DNRS program after the initial 4-month waiting period
Treatment Details
Interventions
- Dynamic Neural Retraining System
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
College of Physicians and Surgeons of Alberta
Collaborator