ME/CFS Brain Fog: Cognitive Rehabilitation Trial

This study is looking for adults with ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) who experience brain fog and cognitive (thinking) difficulties. The goal is to compare two ways to improve brain fog: "Processing Speed Training" (computer-based video games to help you process information faster) and "In-session Instrumental Activities of Daily Living Training" (training on everyday tasks that involve thinking, like managing finances). Both approaches also include a "Transfer Package" to help you use what you learn in daily life, and follow-up phone calls. Some participants will also receive "Trans-auricular Vagus Nerve Stimulation" (a procedure that stimulates a nerve in your ear). To join, you need a diagnosis of ME/CFS before your cognitive problems started, and have at least mild cognitive impairment and moderate brain fog. The study will measure success by looking at how your performance in daily activities changes. The current recruitment status is unclear.

Study design: This is an interventional study planning to enroll 30 participants. Participants will be randomly assigned to one of the two treatment groups.
What's involved: You will have most procedures over the phone or secure telehealth. You will also visit UAB three times for blood samples and brain imaging (about 2 hours each visit). Online testing will occur before, during, and after treatment, and 6 months later.
Compensation: Not stated in the trial record.
Follow-up: You will have four weekly follow-up phone calls in the first month after completing training. Online testing will also happen 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

ME/CFS Brain Fog: Cognitive Rehabilitation Trial

Recruiting

NAAges 18+InterventionalTreatment

University of Alabama at Birmingham

~30 participants

Updated 2026-08-14 on ClinicalTrials.gov

What's tested:Processing Speed TrainingIn-session Instrumental Activities of Daily Living TrainingTransfer PackageFollow Up Phone CallsTrans-auricular Vagus Nerve Stimulation: High IntensityIn-session Brain Health Training

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Canadian Occupational Performance Measure (COPM)

Measured over Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment)

Conditions

ME/CFS

ME/CFS Following EBV-associated Infectious Mononucleosis

ME/CFS Following COVID-19

Chronic Fatigue

Chronic Fatigue Syndrome (CFS)

Brain Fog

Cognitive Impairment

Cognitive Dysfunction

Where it's being run

1 sites across 1 states

Alabama1

Study leadership

Gitendra Uswatte, PhD · PRINCIPAL_INVESTIGATOR · Professor of Psychology, University of Alabama at Birmingham

Who to contact

Madeline Rathz, BS

[email protected]

205-934-9768

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Canadian Occupational Performance Measure (COPM)Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment)
The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome.

Trialytics