What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Long COVID Syndrome, particularly those focusing on cognitive dysfunction such as cognitive training programs, generally have minimal physical side effects. However, patients may experience mental fatigue or frustration due to the cognitive demands of the exercises. Broader treatments for Long COVID, such as structured return-to-activity programs, may lead to temporary increases in fatigue or malaise if not properly titrated. Psychological treatments, including therapy for anxiety and depression, may have side effects related to the specific medications used, such as antidepressants or antipsychotics, which can include nausea, weight gain, or sleep disturbances.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Long COVID Syndrome, particularly targeting cognitive dysfunction such as executive function and attention. However, various interventions, including cognitive training programs, are being studied in clinical trials to address these symptoms. These programs aim to enhance cognitive domains affected by Long COVID, but they are still under investigation and not yet approved by the FDA.

What other types of research exist?

Promising novel alternatives to cognitive training programs for Long COVID Syndrome patients include transcranial direct current stimulation (tDCS) and pharmacological interventions such as acetylcholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine). These treatments have shown potential in improving cognitive functions like executive function and attention.

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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 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)

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

0 / 7Eligibility criteria met

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.