Cognitive rehabilitation for ME/CFS brain fog

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two cognitive rehabilitation methods in adults with post-viral cognitive syndrome and ME/CFS. Participants undergo online testing at set intervals and have in-person visits for blood draws and brain imaging. The trial uses randomization to assign participants to Constraint-Induced Cognitive Therapy or another training approach, delivered largely via telehealth with some in-person assessments. Procedures include brief online assessments before and after treatment and a 6-month follow-up to gauge sustained effects. Key components include processing speed training, daily living activities training, a transfer package, follow-up calls, and optional trans-auricular vagus nerve stimulation at high intensity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* diagnosis of ME/CFS that preceded cognitive complaints
* mild or greater cognitive impairment
* moderate or greater brain fog
* some impairment in the performance of daily activities
* ≥ 18 years, no upper limit if medically stable
* reside in the community (as opposed to a hospital or skilled nursing facility)
* able to travel to the laboratory on multiple occasions
* has Internet service
* has a personal computer, laptop, or tablet that can access the Internet
* sufficiently fit, from both a physical and mental health perspective, to take part in the study
* adequate sight and hearing to complete the UFOV test
* adequate thinking skills, e.g., ability to follow directions and retain information to complete UFOV and CTAL, as marked by the judgement of the screener that the candidate is able to adequately complete the UFOV and CTAL
* sufficient English proficiency (i.e., ability to speak, understand, read, and write to take part in study activities)

Exclusion Criteria:

* cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse, or due to another type of brain injury, such as traumatic brain injury, stroke, or a progressive brain disease, such as Alzheimer's Dementia
* current substance abuse disorder
* diagnosis of postural orthostatic tachycardia syndrome (POTS) by a healthcare provider
* prior cognitive processing speed training on DoubleDecision or a similar program
* cannot tolerate taVNS
* prior history of heart attack or other serious cardiac events
* implanted medical device of any type
* vasovagal syncope or history of fainting
* history of seizures or epilepsy
* temporomandibular Joint (TMJ) syndrome or other conditions that cause substantial jaw pain
* history of peripheral nerve injury to the head, neck, or face
* pregnant or breastfeeding
* not able or willing to get an MRI scan
* not able or willing to get a blood draw

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Gitendra Uswatte, PhD — Professor of Psychology, University of Alabama at Birmingham
• Study coordinator: Madeline Rathz, BS
• Email: mgrathz@uab.edu
• Phone: 205-934-9768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.