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Behavioural Intervention
Cognitive Dysfunction Interventions for Long COVID
N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization
≥ 18 years of age at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, eoi (day 70), eos (day 160)
Awards & highlights
Study Summary
This trial is designed to evaluate interventions for cognitive decline due to PASC, and can be used in different settings to help people with COVID-19 related cognitive issues.
Who is the study for?
Adults over 18 who've had cognitive issues for at least 12 weeks after COVID-19, scoring below 40 on a cognitive test. They must have had symptoms like fever and cough or been in contact with a confirmed case. Participants need to speak English or Spanish and can't be using certain drugs for neurological conditions, substance abuse disorders, or other clinical trials.Check my eligibility
What is being tested?
The trial is testing different treatments for long-term cognitive problems after COVID-19. It includes active tDCS (a brain stimulation technique), sham tDCS (placebo), BrainHQ exercises, and PASC CoRE activities. The study randomly assigns participants to these interventions to see which helps improve attention and executive function.See study design
What are the potential side effects?
tDCS may cause mild side effects like itching, tingling, headache, fatigue during application; BrainHQ exercises are non-invasive but could lead to mental fatigue due to the nature of cognitive tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had COVID-19 before.
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I am 18 years old or older.
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I have symptoms like fever and cough or have been in contact with someone with COVID-19.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, eoi (day 70), eos (day 160)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, eoi (day 70), eos (day 160)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Everyday Cognition 2 (ECog2)
Change in PROMIS-cognitive function - short form 8a (PROMIS-Cog) total score
Change on an objective neurocognitive battery scores
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BrainHQ + PASC CoREExperimental Treatment2 Interventions
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
Group II: BrainHQExperimental Treatment1 Intervention
5 sessions/week at 30 min/session
Group III: Brain HQ + tDCS-activeExperimental Treatment2 Interventions
2.0 mA stimulation delivered for 30 min during each BrainHQ session
Group IV: BrainHQ Active ComparatorActive Control1 Intervention
5 sessions/week at 30 min/session
Group V: Brain HQ + tDCS-shamPlacebo Group2 Interventions
Inactive stimulation delivered for 30 min during each BrainHQ session
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,754 Total Patients Enrolled
Daniel Laskowitz, MD MHSStudy ChairDuke University
1 Previous Clinical Trials
315 Total Patients Enrolled
Kanecia Zimmerman, MD PhDStudy ChairDuke University
2 Previous Clinical Trials
1,215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in either English or Spanish.I have been diagnosed with chronic fatigue syndrome not due to COVID-19.I am currently using a stimulant for post-COVID symptoms.I have had COVID-19 before.You have a serious mental or neurological condition that is unstable or getting worse, and it could make it hard to see if the treatment is working.I am currently using medications or substances that affect my mood or energy.I have good vision, hearing, and movement to participate in the study.I have not had an active COVID-19 infection in the last 4 weeks.I have had thinking or memory problems for over 12 weeks after a COVID-19 infection.You are currently diagnosed with alcohol or drug use disorders.Your cognitive function score is below 40.I am 18 years old or older.You have used a specific treatment within the last 2 months.You are allergic to any of the ingredients in the treatment or the comparison drug.I have symptoms like fever and cough or have been in contact with someone with COVID-19.Criterion: You are suspected of having a SARS-CoV-2 infection.
Research Study Groups:
This trial has the following groups:- Group 1: BrainHQ Active Comparator
- Group 2: BrainHQ
- Group 3: BrainHQ + PASC CoRE
- Group 4: Brain HQ + tDCS-active
- Group 5: Brain HQ + tDCS-sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experiment still open?
"Per the information available on clinicaltrials.gov, this medical trial is currently not recruiting patients; its first post date was July 1st 2023 and it has most recently been edited July 25th of the same year. Nevertheless, there are 1336 other clinical studies in search of participants presently."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I'm desperate and have had cocid 4 times before August of 2021 and doctors didn't believe me.
PatientReceived 1 prior treatment
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