Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965739
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-07-25
Brief Title:
RECOVER-NEURO Platform Protocol Appendix_A to Measure the Effects of BrainHQ PASC CoRE and tDCS Interventions on Long COVID Symptoms
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
RECOVER-NEURO A Platform Protocol for Evaluation of Interventions for Cognitive Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection PASC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OTA-21-015G | OTHER_GRANT | NIH grant to RTI RTI subcontracting with DCRI | None |