RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms

Duke University

Status: Completed

Conditions: Long Covid19; Long Covid-19; Long COVID

Treatments: Other: BrainHQ/Active Comparator Activity; Other: BrainHQ; Device: tDCS-active; Device: tDCS-sham; Other: PASC CoRE

Study type: Interventional

Funder types: Other

Identifiers

NCT05965739

Pro00112477_A

OTA-21-015G (Other Grant/Funding Number)

Details and patient eligibility

About

This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within health care systems, for remote settings, and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating potential interventions for PASC-mediated cognitive dysfunction. The hypothesis is that PASC-associated dysfunction in cognitive domains, such as executive function and attention, may be improved by interventions that selectively focus on enhancing those domains.

This design seeks to evaluate each intervention relative to the Active Comparator. The BrainHQ (alone) arm is important because the intervention is commercially available, accessible, relatively inexpensive, and does not require trained personnel to administer. BrainHQ has been also been proven effective in other studies of cognitive dysfunction such as studies in aging, mild cognitive impairment, traumatic brain injury, among others. The BrainHQ + PASC CoRE arm and the BrainHQ + tDCS arms are suspected to provide cognitive improvements beyond BrainHQ alone through different mechanisms. Both PASC CoRE and tDCS have extensive prior use and have demonstrated utility in improving aspects of cognitive function in other clinical settings..

Full description

Participants will be randomized to one of the intervention appendices that are actively enrolling at the time of randomization. Intervention appendices may be added or removed according to adaptive design and/or emerging evidence. Various interventions will be studied.

Participants will be randomized equally across the five arms:

1. Active Comparator (video games)
2. BrainHQ
3. BrainHQ + PASC CoRE
4. BrainHQ + tDCS-active
5. BrainHQ + tDCS-sham

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Additional Appendix (Sub-study) Level Exclusion Criteria:

1. Presence of metal objects in the head or neck
2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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328 participants in 5 patient groups, including a placebo group

BrainHQ Active Comparator

Active Comparator group

Description:

5 sessions/week at 30 min/session

Treatment:

Other: BrainHQ/Active Comparator Activity

BrainHQ

Experimental group

Description:

5 sessions/week at 30 min/session

Treatment:

Other: BrainHQ

BrainHQ + PASC CoRE

Experimental group

Description:

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

Treatment:

Other: PASC CoRE

Other: BrainHQ

Brain HQ + tDCS-active

Experimental group

Description:

2.0 mA stimulation delivered for 30 min during each BrainHQ session

Treatment:

Device: tDCS-active

Other: BrainHQ

Brain HQ + tDCS-sham

Placebo Comparator group

Description:

Inactive stimulation delivered for 30 min during each BrainHQ session

Treatment:

Device: tDCS-sham

Other: BrainHQ