Cognitive Rehabilitation for Long COVID

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

328 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests different treatments to help people who have cognitive problems after COVID-19. It includes an online brain training program, specialized rehab exercises, and mild electrical brain stimulation. The goal is to see if these methods can improve attention and executive function. Mild electrical brain stimulation has been used in the rehabilitation of cognitive function in various neurological disorders since 2000.

Research Team

Kanecia Zimmerman, MD PhD

Principal Investigator

Duke University

Daniel Laskowitz, MD MHS

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+