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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
Must not have
Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome, not related to SARS-CoV-2 infection
Current use of a stimulant for treating any PASC-related symptom
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, eoi (day 70), eos (day 160)

Summary

This trial is testing various treatments to help people who have thinking and attention problems after recovering from COVID-19. The goal is to find ways to improve these specific cognitive functions. A Ginkgo biloba extract has been suggested for treating cognitive post-COVID-19 symptoms due to its neuroprotective and anti-inflammatory properties.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with chronic fatigue syndrome not due to COVID-19.
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I am currently using a stimulant for post-COVID symptoms.
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I am currently using medications or substances that affect my mood or energy.
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I have good vision, hearing, and movement to participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, eoi (day 70), eos (day 160)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, eoi (day 70), eos (day 160) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total number of participants enrolled in each Appendix
Secondary study objectives
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 more

Trial 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Long COVID Syndrome, particularly those targeting cognitive dysfunction, include cognitive training programs that enhance executive function and attention. These programs work by engaging patients in structured tasks designed to improve specific cognitive skills, such as memory, problem-solving, and attention control. The mechanisms of action involve neuroplasticity, where repeated cognitive exercises strengthen neural connections and improve brain function. This is crucial for Long COVID patients as cognitive impairments can significantly impact daily life, and improving these functions can enhance overall quality of life and independence.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,121 Total Patients Enrolled
Daniel Laskowitz, MD MHSStudy ChairDuke University
1 Previous Clinical Trials
328 Total Patients Enrolled
Kanecia Zimmerman, MD PhDStudy ChairDuke University
2 Previous Clinical Trials
1,292 Total Patients Enrolled

Media Library

BrainHQ (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05965752 — N/A
Long COVID Syndrome Research Study Groups: BrainHQ Active Comparator, BrainHQ, BrainHQ + PASC CoRE, Brain HQ + tDCS-active, Brain HQ + tDCS-sham
Long COVID Syndrome Clinical Trial 2023: BrainHQ Highlights & Side Effects. Trial Name: NCT05965752 — N/A
BrainHQ (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965752 — N/A
~146 spots leftby Dec 2025