Chronic Fatigue Syndrome Trial, Recruiting NCT06915324 Sponsor: Columbia University Condition: Chronic Fatigue Syndrome
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Chronic Fatigue Syndrome Trial, Recruiting

NCT06915324
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Lyme disease by a healthcare provider, meeting certain diagnostic standards (definite, probable, or possible)
  • You are willing to share past Lyme disease test results and/or related medical records
  • You have received at least 2 separate courses of antibiotics for Lyme disease
  • You still have thinking or memory problems that are linked to Lyme disease, even after taking antibiotics
  • These cognitive (thinking/memory) problems currently get in the way of daily life or cause you distress
  • You show signs of slower-than-usual thinking speed on a screening test given by the study team
  • You are willing to stop taking antibiotics for tick-borne illness for at least 4 weeks before the study starts and throughout the 12-week study
  • You are willing to avoid starting new medications during the trial unless medically necessary, and to inform the study team of any medication changes
  • You live in the US or Canada and are comfortable communicating in English
  • You are between 18 and 70 years old
  • You have reliable, ongoing access to the internet
  • You have a suitable home environment with enough space and a quiet, distraction-free area
  • You are able to commit to the full 12-week study period, including 4 weeks of training and an 8-week follow-up visit
  • You have an estimated general intellectual ability score of 85 or above (assessed by the study team)

Who may not be able to join:

  • You have an unstable, non-Lyme-related chronic health condition that has been a problem in the last 12 months (for example, active cancer, recent heart attack, or poorly controlled high blood pressure)
  • You have a severe skin condition or sensitive skin near the forehead area where a device would be used
  • You have a history of traumatic brain injury with ongoing symptoms
  • You have a history of seizures, or have had a seizure within the last 5 years
  • You have had brain surgery
  • You have had moderate to severe chronic headaches or migraines within the last month
  • You have had a stroke that left lasting effects that could interfere with the assessments
  • You have a progressive brain or neurological condition that could affect the study results (confirm with trial site)
  • You have a history of intellectual disability or a developmental condition affecting thinking and memory
  • You currently have a primary psychiatric disorder that would prevent you from fully participating
  • You currently have an alcohol or substance use disorder
  • You are currently considered at any level of suicide risk, as assessed by a standard screening tool
  • You have had suicidal behavior in the past year
  • You have a diagnosis of a psychotic disorder, mania, or bipolar disorder
  • You have moderate or severe depression at the time of screening
  • You are currently taking opioid-based medications, dissociative drugs (prescribed or otherwise), or other medications the study team believes could affect results
  • Your current daily medications have not been at a stable dose for at least 4 weeks before the study begins
  • You have a medical device implanted in your head (such as a deep brain stimulator) or neck (such as a vagus nerve stimulator), or metal implants in your head or neck
  • You do not have adequate vision or physical ability to use a computer and study equipment regularly, or you are unable to give informed consent
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • You are not willing to avoid starting, restarting, or increasing other brain-training programs, cognitive supplements, or similar therapies during the trial

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Brian A Fallon, MD, Columbia University

Phone: 646-774-8108

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
14 July 2025
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Coding test scale score for acute treatment; Coding test scale score for post-treatment follow-up

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov