Cognitive Rehabilitation for Long COVID

No longer recruiting at 2 trial locations

Overseen By Barrie Harper, BSMT (ASCP) PMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Metal objects, Skin disorders, others

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to assist people with Long COVID who struggle with thinking skills, such as focusing and problem-solving. It tests various treatments, including BrainHQ, a brain training program, both alone and combined with other techniques like PASC CoRE and tDCS (a type of mild brain stimulation). The goal is to determine if these treatments can improve cognitive functions often affected by Long COVID. This trial suits individuals experiencing cognitive issues due to Long COVID symptoms. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could lead to new solutions for cognitive challenges associated with Long COVID.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BrainHQ, a brain training program, effectively improves thinking skills in older adults and those with mild memory problems. It is considered safe and well-tolerated, with no major side effects reported.

When combined with PASC CoRE, a program for enhancing thinking skills, studies suggest it can further improve cognitive function. Although specific side effects for PASC CoRE are not detailed, it employs well-known methods that are generally safe.

For transcranial direct current stimulation (tDCS), research indicates it is safe for treating brain-related issues. Some individuals might experience mild and short-lived side effects like skin irritation, but overall, it is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to tackling cognitive challenges associated with Long COVID, or PASC (Post-Acute Sequelae of SARS-CoV-2 infection). Unlike traditional cognitive therapies, which might rely on general cognitive exercises, BrainHQ provides targeted brain training exercises designed to improve specific cognitive functions. Additionally, the combination of BrainHQ with tDCS (transcranial direct current stimulation), whether active or sham, introduces a novel method that could enhance cognitive training's effectiveness by modulating brain activity. Moreover, the inclusion of PASC CoRE—a comprehensive rehabilitation program—adds a holistic approach that integrates group and individual sessions, potentially addressing both cognitive and emotional aspects of recovery. These unique elements could offer promising new avenues for improving cognitive health in Long COVID patients.

What evidence suggests that this trial's treatments could be effective for cognitive dysfunction in Long COVID?

Research has shown that BrainHQ may improve thinking and memory in conditions such as aging, mild cognitive impairment, and brain injuries. This suggests it might also aid memory and thinking problems associated with Long COVID. In this trial, some participants will receive BrainHQ combined with PASC CoRE, which includes methods like Goal Management Training. These methods have succeeded in other brain rehabilitation programs and may enhance cognitive skills.

Other participants will receive BrainHQ combined with active tDCS, a gentle electrical brain stimulation. Studies have found that tDCS can improve attention and thinking speed in individuals with cognitive issues from Long COVID. These findings suggest that these treatments could effectively help people with Long COVID enhance their cognitive function. ^{6 7 8 9 10}

Who Is on the Research Team?

Kanecia Zimmerman, MD PhD

Principal Investigator

Duke University

Daniel Laskowitz, MD MHS

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals with Long COVID who experience cognitive issues like trouble with thinking or attention. Participants must meet the broader RECOVER-NEURO protocol criteria and cannot have metal objects in their head/neck, skin conditions near tDCS stimulation sites, or any other risks as determined by the investigator.

Inclusion Criteria

See NCT05965752 for RECOVER-NEURO: Platform Protocol level inclusion criteria which applies to this appendix

Exclusion Criteria

Skin disorders or skin-sensitive areas near tDCS stimulation locations that would interfere with electrode placement or increase the risk of stimulation-induced damage, at the investigator's discretion

See NCT05965752 for RECOVER-NEURO: Platform Protocol level exclusion criteria which applies to this appendix

You have metal objects in your head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interventions such as BrainHQ, BrainHQ + PASC CoRE, or BrainHQ + tDCS for cognitive dysfunction

10 weeks

5 sessions/week at 30 min/session

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BrainHQ
• BrainHQ/Active Comparator Activity
• PASC CoRE
• tDCS-active
• tDCS-sham

Trial Overview

The study tests BrainHQ exercises alone, combined with PASC CoRE (a cognitive rehabilitation program), or paired with active/sham tDCS (transcranial direct current stimulation) to see if they improve cognition in Long COVID patients compared to standard activities.

How Is the Trial Designed?

Group I: BrainHQ + PASC CoRE Experimental Treatment 2 Interventions

BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session

Group II: BrainHQ Experimental Treatment 1 Intervention

5 sessions/week at 30 min/session

Group III: Brain HQ + tDCS-active Experimental Treatment 2 Interventions

2.0 mA stimulation delivered for 30 min during each BrainHQ session

Group IV: BrainHQ Active Comparator Active Control 1 Intervention

5 sessions/week at 30 min/session

Group V: Brain HQ + tDCS-sham Placebo Group 2 Interventions

Inactive stimulation delivered for 30 min during each BrainHQ session

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

nature.com

nature.com/articles/s41591-024-02987-8

Three-year outcomes of post-acute sequelae of COVID-19

Our findings show reduction of risks over time, but the burden of mortality and health loss remains in the third year among hospitalized individuals.

2.

recovercovid.org

recovercovid.org/publications/development-definition-postacute-sequelae-sars-cov-2-infection

Development of a definition of postacute sequelae of SARS ...

To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ...

Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0003999324007779

Long COVID (Post Acute Sequelae of SARS-CoV-2 ...

Objective(s). To assess and report current effective treatments on clinical outcomes for adults with Long-COVID. Data Sources. We searched PubMed ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11418572/

Long COVID or Post-Acute Sequelae of SARS-CoV-2 Infection ...

The study aimed to identify the symptoms present in SARS-CoV-2-infected individuals at six months or more after infection compared with uninfected individuals ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8260991/

Long COVID or Post-acute Sequelae of COVID-19 (PASC)

This paper details mechanisms by which RNA viruses beyond just SARS-CoV-2 have be connected to long-term health consequences.

7.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08156-z

RECOVER-NEURO: study protocol for a multi-center ... - Trials

Post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID, is a chronic condition present in at least 45% of COVID-19 survivors [1]. The ...

8.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2805540

Development of a Definition of Postacute Sequelae ...

This study aims to develop a definition of postacute sequelae of SARS-CoV-2 infection (PASC) based on self-reported symptoms and describe ...

9.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00177-3/fulltext

Long-term post-acute sequelae of COVID-19 infection

This study aims to generate coherent evidence on the risk of long-term clinical sequelae of patients recovering from COVID-19 infection using ...

10.

nature.com

nature.com/articles/s41591-023-02521-2

Postacute sequelae of COVID-19 at 2 years

SARS-CoV-2 infection can lead to postacute sequelae in multiple organ systems, but evidence is mostly limited to the first year postinfection.