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Behavioural Intervention

Cognitive Rehabilitation for Long COVID Brain Fog

N/A

Recruiting

Led By Gitendra Uswatte, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mild or greater cognitive impairment

Moderate or greater brain fog

Must not have

Cognitive impairment due to developmental disability, psychiatric disorder, or substance abuse, TBI or progressive brain disease

Stroke prior to the onset of COVID

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from day 30 to day 60, i.e., from pre- to post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two different cognitive rehabilitation approaches for adults with long COVID who have mild to moderate cognitive impairment. One approach focuses on training how quickly individuals process information through web-based computer games and in-l

Who is the study for?

Adults with long COVID experiencing mild to moderate cognitive issues, such as brain fog and trouble with daily activities. They must be over 3 months post-COVID, able to travel to the lab, mentally and physically fit enough for participation, have good vision and hearing, follow instructions well, and speak English. Excluded are those with a history of stroke before COVID-19 or current substance abuse.

What is being tested?

The trial compares two cognitive rehabilitation methods: Constraint-Induced Cognitive Therapy (CICT) focuses on processing speed training and practical tasks including work-related ones; Brain Fitness Training (BFT) emphasizes reaction time training along with lifestyle habits like relaxation. Both use non-invasive vagus nerve stimulation (taVNS) and may include vocational rehab for eligible participants.

What are the potential side effects?

Potential side effects mainly relate to taVNS which could cause discomfort at the stimulation site or other unknown reactions due to its nature as a relatively new treatment method.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience some difficulty with my memory or thinking.

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I experience significant confusion or difficulty thinking.

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I can see and hear well enough for daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive issues due to a developmental disability, mental health condition, substance abuse, brain injury, or progressive brain disease.

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I had a stroke before getting COVID.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from day 30 to day 60, i.e., from pre- to post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from day 30 to day 60, i.e., from pre- to post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from day 30 to day 60, i.e., from pre- to post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Canadian Occupational Performance Measure (COPM)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: CICT + VRExperimental Treatment7 Interventions

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.

Group II: CICTExperimental Treatment5 Interventions

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.

Group III: BFTActive Control5 Interventions

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.

Group IV: BFT + VRActive Control6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Processing Speed Training

2013

N/A

~70

Peer Mentoring

2018

N/A

~1410