ME/CFSNCT07523113
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
A study testing Processing Speed Training, In-session Instrumental Activities of Daily Living Training and Transfer Package in people with ME/CFS and ME/CFS Following EBV-associated Infectious Mononucleosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis, ME/CFS Following COVID-19
- What is being tested?
- Processing Speed Training, In-session Instrumental Activities of Daily Living Training and Transfer Package
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Madeline Rathz, BS, 205-934-9768, mgrathz@uab.edu
Helen Bliss, BS, 205-934-0433, hmbliss@uab.edu
About this study
Official title: Brain Training for Chronic, Post-viral, Brain Fog: Study A
The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.
- Conditions
- ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis, ME/CFS Following COVID-19, Chronic Fatigue, Chronic Fatigue Syndrome (CFS), Brain Fog
- Being tested
- Processing Speed Training, In-session Instrumental Activities of Daily Living Training, Transfer Package, Follow Up Phone Calls, Trans-auricular Vagus Nerve Stimulation: High Intensity
- Keywords
- ME/CFS, Chronic Fatigue, Brain fog, Cognitive Impairment, Cognitive Dysfunction, post-viral syndrome, Cognitive Rehabilitation, CICT
- Medical subject headings
- Fatigue Syndrome, Chronic, Mental Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processing Speed TrainingBehavioural
Also called SOPT
Speed of processing training involves trainer-guided practice of computer-based video "games." The games require the "player" to rapidly distinguish targets from decoys, which trains the player to process information from their senses quickly.
In-session Instrumental Activities of Daily Living TrainingBehavioural
Also called IADL Training
Participants will receive shaping on IADLs. Participants will receive training on everyday tasks with important cognitive components, in which the difficulty is increased in small steps over the course of treatment.
Transfer PackageBehavioural
Also called TP
The Transfer Package was designed to try to bridge the gap between what is trained in-session and what the participant does outside of treatment sessions. These components include negotiation of a behavioral contract with participants at the outset of treatment regarding the responsibilities of the participant, family caregivers, if available, and the treatment team, self-monitoring, assignment of "homework," review of homework by the trainer, and support of problem-solving by the participant.
Follow Up Phone CallsBehavioural
After completing training, participants will receive four weekly follow-up phone calls in the first month of training. The focus of the calls will incorporate the lessons learnt during treatment into daily life.
Trans-auricular Vagus Nerve Stimulation: High IntensityProcedure or surgery
Also called taVNS
The vagus nerve runs from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest-and-relax response can be activated by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of at least 4 milliamps. Stimulation will be administered for 10 minutes near the start and midway point of each treatment session.
In-session Brain Health TrainingBehavioural
Participants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health.
Reaction Time TrainingBehavioural
Reaction time training involves trainer-guided practice of computer-based video "games." Several different games will be featured that train how rapidly "players" react to "threats" and train eye-hand coordination.
Trans-auricular Vagus Nerve Stimulation: Low IntensityProcedure or surgery
The vagus nerve run from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest and relax response can be turned on by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of less than 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session.
| Study group | Role | What they receive |
|---|---|---|
| CICT + taVNS | Experimental | Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components, along with the procedures designed to transfer improvements from the treatment setting to everyday life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. Receives: Behavioral: Processing Speed Training; Behavioral: In-session Instrumental Activities of Daily Living Training; Behavioral: Transfer Package; Behavioral: Follow Up Phone Calls; Procedure: Trans-auricular Vagus Nerve Stimulation: High Intensity |
| BFT + taVNS | Active comparator | Brain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based reaction time training and non-invasive vagus nerve stimulation. Receives: Behavioral: Transfer Package; Behavioral: Follow Up Phone Calls; Behavioral: In-session Brain Health Training; Behavioral: Reaction Time Training; Procedure: Trans-auricular Vagus Nerve Stimulation: Low Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
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.
Measured: Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start23 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ME/CFSStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- UAB College of Arts and Sciences & Department of Psychology, Posit Science Corporation
- Responsible party
- Principal investigator, Gitendra Uswatte, University of Alabama at Birmingham
- Investigators
- Gitendra Uswatte, PhD, Principal investigator, Professor of Psychology, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523113
- Sponsor's protocol ID
- IRB-300015629
- Other IDs
- UAB CAS
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Training for Chronic, Post-viral, Brain Fog: Study A
- ClinicalTrials.gov ID
- NCT07523113
- Acronym / sponsor ID
- IRB-300015629
- Conditions
- ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis, ME/CFS Following COVID-19, Chronic Fatigue, Chronic Fatigue Syndrome (CFS), Brain Fog
- Keywords
- ME/CFS, Chronic Fatigue, Brain fog, Cognitive Impairment, Cognitive Dysfunction, post-viral syndrome, Cognitive Rehabilitation, CICT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- UAB College of Arts and Sciences & Department of Psychology, Posit Science Corporation
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CICT + taVNS | Experimental | Behavioral: Processing Speed Training, Behavioral: In-session Instrumental Activities of Daily Living Training, Behavioral: Transfer Package, Behavioral: Follow Up Phone Calls, Procedure: Trans-auricular Vagus Nerve Stimulation: High IntensityConstraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components, along with the procedures designed to transfer improvements from the treatment setting to everyday life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. |
| BFT + taVNS | Active comparator | Behavioral: Transfer Package, Behavioral: Follow Up Phone Calls, Behavioral: In-session Brain Health Training, Behavioral: Reaction Time Training, Procedure: Trans-auricular Vagus Nerve Stimulation: Low IntensityBrain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based reaction time training and non-invasive vagus nerve stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Processing Speed TrainingAlso: SOPTSpeed of processing training involves trainer-guided practice of computer-based video "games." The games require the "player" to rapidly distinguish targets from decoys, which trains the player to process information from their senses quickly. | Behavioural | CICT + taVNS |
| In-session Instrumental Activities of Daily Living TrainingAlso: IADL TrainingParticipants will receive shaping on IADLs. Participants will receive training on everyday tasks with important cognitive components, in which the difficulty is increased in small steps over the course of treatment. | Behavioural | CICT + taVNS |
| Transfer PackageAlso: TPThe Transfer Package was designed to try to bridge the gap between what is trained in-session and what the participant does outside of treatment sessions. These components include negotiation of a behavioral contract with participants at the outset of treatment regarding the responsibilities of the participant, family caregivers, if available, and the treatment team, self-monitoring, assignment of "homework," review of homework by the trainer, and support of problem-solving by the participant. | Behavioural | BFT + taVNS, CICT + taVNS |
| Follow Up Phone CallsAfter completing training, participants will receive four weekly follow-up phone calls in the first month of training. The focus of the calls will incorporate the lessons learnt during treatment into daily life. | Behavioural | BFT + taVNS, CICT + taVNS |
| Trans-auricular Vagus Nerve Stimulation: High IntensityAlso: taVNSThe vagus nerve runs from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest-and-relax response can be activated by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of at least 4 milliamps. Stimulation will be administered for 10 minutes near the start and midway point of each treatment session. | Procedure or surgery | CICT + taVNS |
| In-session Brain Health TrainingParticipants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health. | Behavioural | BFT + taVNS |
| Reaction Time TrainingReaction time training involves trainer-guided practice of computer-based video "games." Several different games will be featured that train how rapidly "players" react to "threats" and train eye-hand coordination. | Behavioural | BFT + taVNS |
| Trans-auricular Vagus Nerve Stimulation: Low IntensityThe vagus nerve run from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest and relax response can be turned on by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of less than 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session. | Procedure or surgery | BFT + taVNS |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gitendra Uswatte, PhD principal investigator
Professor of Psychology, University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processing Speed Training, In-session Instrumental Activities of Daily Living Training and Transfer Package in people with ME/CFS and ME/CFS Following EBV-associated Infectious Mononucleosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline Rathz, BS (205-934-9768, mgrathz@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.