Chronic Fatigue Syndrome Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with Lyme disease (definite or highly probable) by a healthcare provider, and that diagnosis and treatment happened more than 6 months ago.
• You currently have one or more symptoms that you believe are related to Lyme disease, and those same symptoms were also present in the first 6 months after you were diagnosed and treated.
• Your current symptoms cause meaningful distress or get in the way of your daily life.
• You have already been treated for Lyme disease with at least two rounds of antibiotics appropriate for Lyme disease.
• You are willing to avoid starting any new medical or psychiatric treatments that could affect the study results while the study is ongoing, unless your regular doctor says it is necessary.
• Any current treatments you are taking that could affect the study results have been unchanged for at least 6 weeks before your first study visit.
• You live in the United States and have access to a smartphone, tablet, or computer with internet.
• You can read and understand English well enough to give your informed consent.
• You are able and willing to travel to Columbia University Irving Medical Center in New York City for 3 to 5 study visits.
• You are willing to have a heart tracing test (EKG) done at the study site, and if you had one done in the past year, you are willing to try to get a copy for the study team to review.
• You currently have moderate to severe tiredness/fatigue, scoring 4 or higher on a standard fatigue rating scale.
• You are able to set aside enough time for the treatment sessions, including 6 sessions that take place during daytime hours (8am to 6pm).

Who may not be able to join:

• You have a current or past heart or blood vessel condition, such as coronary artery disease, stroke, or other major heart problems; or you have had unexplained fainting, fainting in medical settings, an abnormally slow heart rate, low blood pressure when standing up, or persistently low blood pressure in the past year.
• You have had an EKG that showed abnormal results considered significant by a heart doctor (cardiologist).
• You have a diagnosed ongoing major brain or nervous system disease, such as multiple sclerosis, epilepsy, Parkinson's disease, or a traumatic brain injury affecting memory and thinking; or you have had brain surgery or a brain tumor.
• You currently have a psychiatric condition that might make it hard to follow the treatment plan, such as bipolar disorder, psychosis, or substance misuse.
• You have had thoughts of suicide with a specific method, plan, or intent in the last 6 months, or you have a lifetime history of suicidal behaviour.
• You are currently experiencing moderate-to-severe or severe depression based on a standard screening score.
• You currently have a serious unstable medical illness.
• You are currently taking opioid-based pain medication, or you have taken antibiotics for a tick-borne illness within the last 6 weeks.
• You have any ear-related issues, including ear or facial pain, recent ear injury, ear infection, scarring or inflammation on the ear, physical features of the ear that would prevent a small ear device from being used, or a cochlear implant.
• You are currently in, or have been in within the last 6 months, another clinical trial testing an investigational medicine or medical device.
• You are pregnant or planning to become pregnant during the study.
• You are unable to connect to the internet during the treatment phase of the study.
• You have an active electrical medical device inside or outside your body, such as a pacemaker or implanted hearing device, or any metal implant in your head or neck area.
• You have had surgery to cut the vagus nerve in your neck (confirm with trial site if unsure what this means).

Important: Always verify eligibility with the trial site directly before applying.