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Cognitive Rehabilitation for Post-COVID-19 Cognitive Impairment
N/A
Recruiting
Led By Edward Taub
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
Presence of cognitive impairment due to Covid-19 infection
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from day 0 to day 17
Awards & highlights
Study Summary
This trial is testing a new therapy to improve thinking skills and how well patients can carry out tasks in their daily lives. The therapy involves intensive, repetitive cognitive exercises for up to 3.5 hours a day for 10 consecutive weekdays, with rest periods as needed. Patients will be randomly assigned to receive the therapy soon or about three months later.
Who is the study for?
This trial is for adults over 18 who've had COVID-19 at least 3 months ago and are now experiencing mild-to-moderate cognitive issues. They should be physically and mentally fit, able to follow instructions, have a caregiver, and can travel to the lab. People with cognitive impairments from developmental disabilities, psychiatric disorders, or substance abuse cannot join.Check my eligibility
What is being tested?
The study tests a new cognitive rehabilitation therapy aimed at improving thinking speed and daily task performance in post-COVID patients. Participants will do intensive exercises for up to 3.5 hours per day over two weeks and will be randomly assigned to start immediately or after three months.See study design
What are the potential side effects?
Since this is a non-drug intervention involving cognitive exercises, typical drug side effects are not expected. However, participants may experience fatigue or mental strain due to the intensity of the training sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have experienced cognitive issues due to Covid-19.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from day 0 to day 17
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from day 0 to day 17
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Canadian Occupation Performance Measure (COPM)
Secondary outcome measures
Assessment of Motor and Process Skills (AMPS)
Cognitive Task Activity Log (CTAL) How Well Scale
Cognitive Task Activity Log (CTAL) Independence Scale
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Immediate TreatmentExperimental Treatment3 Interventions
The treatment will have 3 components. The first component, Speed of Processing Training, is a computer game. Participants identify targets on the screen as rapidly as possible. The second component is training following shaping principles on simulated instrumental activities of daily living (IADL), such as making a telephone call or generating a shopping list, in the treatment setting. Shaping involves progressively increasingly the complexity of a task in incremental steps as a participant gains mastery. Frequent, positive feedback is another important aspect of shaping. The third component is a set of psychological techniques that will help participants apply the improvements from the game to carrying out tasks that rely on thinking in their daily
Group II: Delayed TreatmentExperimental Treatment4 Interventions
Participants in this arm will receive testing on the same schedule as the Immediate Treatment up to six-month followup. Delayed Treatment participants will not receive any treatment from the study during this period but will permitted to receive any healthcare that is available on a clinical basis. After six-month followup, participants in this arm will be crossed over to receive the experimental treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Speed of Processing Training
2011
N/A
~340
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,283,055 Total Patients Enrolled
Edward TaubPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can see and hear well enough to take a vision and hearing test.You have mild to moderate problems with thinking as shown by a test called the Montreal Cognitive Assessment (MOCA) with a score between 10 and 25.I can follow directions and remember information well enough to complete tests.It has been over 3 months since I tested positive for Covid-19.I can visit the lab multiple times.My health condition is currently stable.I am physically and mentally fit to participate in the study.You have trouble thinking clearly because of a developmental disability, mental health condition, or drug/alcohol abuse.I have experienced cognitive issues due to Covid-19.I am 18 years old or older.
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