Long COVIDNCT06095297
Long COVID Brain Fog: Cognitive Rehabilitation Trial
A study testing Processing Speed Training, In-lab Instrumental Activities of Daily Living Training and In-lab Brain Health Training in people with Long COVID and Brain Fog, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Brain Fog, Cognitive Impairment
- What is being tested?
- Processing Speed Training, In-lab Instrumental Activities of Daily Living Training and In-lab Brain Health Training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to Dec 2027
- 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
- >3 months post COVID
- mild or greater cognitive impairment
- moderate or greater brain fog
- impairment in performance of daily activities
- reside in community
- reliable transportation to lab
Show all 10Show fewer
- sufficiently mentally and physically fit
- adequate sight and hearing
- ability to follow directions, and retain information
- sufficient English proficiency
Who cannot join
- cognitive impairment due to developmental disability, psychiatric disorder, or substance abuse, TBI or progressive brain disease
- stroke prior to the onset of COVID
- current substance abuse disorder
- prior cognitive processing speed training on DoubleDecision or similar program
- cannot tolerate trans-auricular vagus nerve stimulation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Technique to Enable Return-to-Work by Employees With Long COVID Brain Fog
This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab 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 (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT).
A subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training.
Read more
CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.
BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.
Participants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT.
Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6-months afterwards. 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. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities.
- Conditions
- Long COVID, Brain Fog, Cognitive Impairment, Cognitive Dysfunction, Post-Acute COVID-19 Syndrome
- Being tested
- Processing Speed Training, In-lab Instrumental Activities of Daily Living Training, In-lab Brain Health Training, Transfer Package, Follow Up Phone Calls
- Keywords
- Long COVID, Brain Fog, Cognitive Impairment, Vocational Rehabilitation, COVID-19, PASC, Cognitive Rehabilitation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Mental Fatigue, Cognitive Dysfunction, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processing Speed TrainingBehavioural
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 how rapidly the player processes information received through their senses.
In-lab Instrumental Activities of Daily Living TrainingBehavioural
Also called In-lab IADL Training
Participant 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.
In-lab Brain Health TrainingBehavioural
Also called In-lab Stress Management Training
Participants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health.
Transfer PackageBehavioural
Also called TP
The Transfer Package was designed to try and bridge the gap between what is trained in the lab and what the participant does outside of the treatment setting. This components includes 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 follow up phone calls in the first month of training. Each call will separated by about a week. The focus of the calls will incorporating the lessons learnt during treatment into daily life.
Vocational RehabilitationBehavioural
In partnership with the Alabama Department of Rehabilitation Services (ADRS), participants who are eligible may receive vocational rehabilitation. Participants will receive typical services offered by the ADRS. These could include career counseling, guidance regarding job retention or return-to-work, and guidance regarding workplace accommodations.
Peer MentoringBehavioural
Participants who are eligible for vocational rehabilitation, and agree will also have a peer mentor, a co-worker that will be trained by our team, to reinforce strategies the participant learned during training, and to help the participant problem solve issues that may arise on the job during the first month after treatment. Peer mentors will meet with trainers during the month after treatment to make sure procedures are being followed and address any issues that may arise.
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: High 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 at least 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session.
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 | Experimental | Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. Receives: Behavioral: Processing Speed Training; Behavioral: In-lab Instrumental Activities of Daily Living Training; Behavioral: Transfer Package; Behavioral: Follow Up Phone Calls; Procedure: Trans-auricular Vagus Nerve Stimulation: High Intensity |
| CICT + VR | Experimental | Constraint-Induced Cognitive Therapy plus Vocational Rehabilitation uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills. Receives: Behavioral: Processing Speed Training; Behavioral: In-lab Instrumental Activities of Daily Living Training; Behavioral: Transfer Package; Behavioral: Follow Up Phone Calls; Behavioral: Vocational Rehabilitation; Behavioral: Peer Mentoring; Procedure: Trans-auricular Vagus Nerve Stimulation: High Intensity |
| BFT | 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: In-lab Brain Health Training; Behavioral: Transfer Package; Behavioral: Follow Up Phone Calls; Behavioral: Reaction Time Training; Procedure: Trans-auricular Vagus Nerve Stimulation: Low Intensity |
| BFT + VR | Active comparator | Brain Fitness Training plus Vocational Rehabilitation 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. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills. Receives: Behavioral: In-lab Brain Health Training; Behavioral: Transfer Package; Behavioral: Follow Up Phone Calls; Behavioral: Vocational Rehabilitation; 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 which is 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., 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 posted23 Oct 2023
- Study start25 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Posit Science
- 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
- NCT06095297
- Sponsor's protocol ID
- IRB-300010908
- Other IDs
- 90IFRE0073
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Technique to Enable Return-to-Work by Employees With Long COVID Brain Fog
- ClinicalTrials.gov ID
- NCT06095297
- Acronym / sponsor ID
- IRB-300010908
- Conditions
- Long COVID, Brain Fog, Cognitive Impairment, Cognitive Dysfunction, Post-Acute COVID-19 Syndrome
- Keywords
- Long COVID, Brain Fog, Cognitive Impairment, Vocational Rehabilitation, COVID-19, PASC, Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, Posit Science
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Oct 2023 (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.
This study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab 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 (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT).
A subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training.
CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.
BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life.
Participants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT.
Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6-months afterwards. 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. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CICT | Experimental | Behavioral: Processing Speed Training, Behavioral: In-lab 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 and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. |
| CICT + VR | Experimental | Behavioral: Processing Speed Training, Behavioral: In-lab Instrumental Activities of Daily Living Training, Behavioral: Transfer Package, Behavioral: Follow Up Phone Calls, Behavioral: Vocational Rehabilitation, Behavioral: Peer Mentoring, Procedure: Trans-auricular Vagus Nerve Stimulation: High IntensityConstraint-Induced Cognitive Therapy plus Vocational Rehabilitation uses in-lab training on everyday activities with important cognitive components and procedures designed to transfer improvements from the treatment setting to every day life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills. |
| BFT | Active comparator | Behavioral: In-lab Brain Health Training, Behavioral: Transfer Package, Behavioral: Follow Up Phone Calls, 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. |
| BFT + VR | Active comparator | Behavioral: In-lab Brain Health Training, Behavioral: Transfer Package, Behavioral: Follow Up Phone Calls, Behavioral: Vocational Rehabilitation, Behavioral: Reaction Time Training, Procedure: Trans-auricular Vagus Nerve Stimulation: Low IntensityBrain Fitness Training plus Vocational Rehabilitation 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. This group will also receive vocational rehabilitation from the Alabama Department of Rehabilitation Services, such as career counseling and building important career skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >3 months post COVID
- mild or greater cognitive impairment
- moderate or greater brain fog
- impairment in performance of daily activities
- reside in community
Key exclusion criteria (5 listed)
- cognitive impairment due to developmental disability, psychiatric disorder, or substance abuse, TBI or progressive brain disease
- stroke prior to the onset of COVID
- current substance abuse disorder
- prior cognitive processing speed training on DoubleDecision or similar program
- cannot tolerate trans-auricular vagus nerve stimulation
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 TrainingSpeed 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 how rapidly the player processes information received through their senses. | Behavioural | CICT, CICT + VR |
| In-lab Instrumental Activities of Daily Living TrainingAlso: In-lab IADL TrainingParticipant 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, CICT + VR |
| In-lab Brain Health TrainingAlso: In-lab Stress Management TrainingParticipants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health. | Behavioural | BFT, BFT + VR |
| Transfer PackageAlso: TPThe Transfer Package was designed to try and bridge the gap between what is trained in the lab and what the participant does outside of the treatment setting. This components includes 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, BFT + VR, CICT, CICT + VR |
| Follow Up Phone CallsAfter completing training, participants will receive four follow up phone calls in the first month of training. Each call will separated by about a week. The focus of the calls will incorporating the lessons learnt during treatment into daily life. | Behavioural | BFT, BFT + VR, CICT, CICT + VR |
| Vocational RehabilitationIn partnership with the Alabama Department of Rehabilitation Services (ADRS), participants who are eligible may receive vocational rehabilitation. Participants will receive typical services offered by the ADRS. These could include career counseling, guidance regarding job retention or return-to-work, and guidance regarding workplace accommodations. | Behavioural | BFT + VR, CICT + VR |
| Peer MentoringParticipants who are eligible for vocational rehabilitation, and agree will also have a peer mentor, a co-worker that will be trained by our team, to reinforce strategies the participant learned during training, and to help the participant problem solve issues that may arise on the job during the first month after treatment. Peer mentors will meet with trainers during the month after treatment to make sure procedures are being followed and address any issues that may arise. | Behavioural | CICT + VR |
| 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, BFT + VR |
| Trans-auricular Vagus Nerve Stimulation: High 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 at least 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session. | Procedure or surgery | CICT, CICT + VR |
| 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, BFT + VR |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment
The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview which is 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.
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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. This study is not recruiting at the moment.
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-lab Instrumental Activities of Daily Living Training and In-lab Brain Health Training in people with Long COVID and Brain Fog, 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 10 inclusion and 5 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: under way, not looking for participants, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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., 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.