Cognitive Dysfunction Interventions for Long COVID

Recruiting at 24 trial locations

Overseen By Barrie Harper, BSMT (ASCP) PMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Stimulants, Amantadine, Memantine, Dissociatives

Disqualifiers: Major psychiatric, Neurologic, Substance use, others

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

328 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Daniel Laskowitz, MD MHS

Principal Investigator

Duke University

Kanecia Zimmerman, MD PhD

Principal Investigator

Duke University

Eligibility Criteria

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.

Inclusion Criteria

Willing and able to provide informed consent, complete the intervention, complete the intervention assessments, and return for all of the necessary follow-up visits

I have had COVID-19 before.

I have had thinking or memory problems for over 12 weeks after a COVID-19 infection.

Exclusion Criteria

I have been diagnosed with chronic fatigue syndrome not due to COVID-19.

I am currently using a stimulant for post-COVID symptoms.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo various cognitive interventions, including BrainHQ sessions and potential additional treatments like tDCS or PASC CoRE

10 weeks

5 sessions/week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

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+