RECOVER-NEURO: Platform Protocol, Appendix_A to Measure the Effects of BrainHQ, PASC CoRE and tDCS Interventions on Long COVID Symptoms
NCT ID: NCT05965739
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
328 participants
INTERVENTIONAL
2023-09-01
2024-12-17
Brief Summary
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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..
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
At the first stage, each participant will be assigned with equal probability to one of the intervention appendices for which the participant is eligible, after applying any intervention-specific safety exclusions. At the second stage, each participant will be assigned according to the specific appendix's randomization procedure. Participants will have an equal chance of being randomized into any of the intervention groups.
TREATMENT
TRIPLE
Sites will be informed to which intervention appendix participants are randomized, but, when applicable, not whether the participants are allocated to the active intervention arm or control arm within that appendix. The participants and investigators will be blinded throughout the study, when possible.
If open intervention appendices do not have the ability to pool controls but have independent controls, at the second stage participants will be randomized in a 1:1 ratio to intervention vs control inside the specific intervention appendix the participants were randomized to at the first stage of the randomization procedure.
Study Groups
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BrainHQ Active Comparator
5 sessions/week at 30 min/session
BrainHQ/Active Comparator Activity
BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
BrainHQ
5 sessions/week at 30 min/session
BrainHQ
BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
BrainHQ + PASC CoRE
BrainHQ plus 9 group sessions at 1.5 hr/session and 3 individual sessions at 1 hr/session
BrainHQ
BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE
PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
Brain HQ + tDCS-active
2.0 mA stimulation delivered for 30 min during each BrainHQ session
BrainHQ
BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-active
Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
Brain HQ + tDCS-sham
Inactive stimulation delivered for 30 min during each BrainHQ session
BrainHQ
BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
tDCS-sham
tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
Interventions
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BrainHQ/Active Comparator Activity
BrainHQ platform provides a set of cognitive activities, like puzzles and games, that are cognitively stimulating and actively engage participants but do not continuously and adaptively challenge them. These activities are designed to be a face-valid, active comparison approach to cognitive therapy, thus participants are blinded, attention time is matched, and overall user experience is identical to the active arms.
BrainHQ
BrainHQ is an online cognitive training program, and has been used to improve cognitive function among persons with cognitive impairment based on principles of neuroplasticity.
PASC CoRE
PASC CoRE is a manualized, adaptable cognitive rehabilitation intervention adapted from Goal Management Training and other evidence based programs that improve attention and executive functions, among other cognitive domains.
tDCS-active
Transcranial direct current stimulation (tDCS) will use a device specifically for home-based use. This device delivers a weak electrical current of 2.0 mA passed through two electrodes placed on the scalp to target the dorsolateral prefrontal cortex region of the brain. The electrodes are single-use for each session and can be attached to a headset by snapping into place.
The device has a user-friendly interface and a large-button keypad, making it is easy to use at home.
tDCS-sham
tDCS devices used in the sham arm will be pre-programmed to deliver the same ramp up/down at the beginning/end of the 30-minute period as the active arm, except with no current otherwise delivered during the session.
Eligibility Criteria
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Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Kanecia Zimmerman, MD PhD
Role: STUDY_CHAIR
Duke University
Daniel Laskowitz, MD MHS
Role: STUDY_CHAIR
Duke University
Locations
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All sites listed under NCT05965752
Durham, North Carolina, United States
Countries
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References
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Knopman DS, Laskowitz DT, Koltai DC, Charvet LE, Becker JH, Federman AD, Wisnivesky J, Mahncke H, Van Vleet TM, Bateman L, Kim DY, O'Steen A, James M, Silverstein A, Lokhnygina Y, Rich J, Feger BJ, Zimmerman KO. RECOVER-NEURO: study protocol for a multi-center, multi-arm, phase 2, randomized, active comparator trial evaluating three interventions for cognitive dysfunction in post-acute sequelae of SARS-CoV-2 infection (PASC). Trials. 2024 May 17;25(1):326. doi: 10.1186/s13063-024-08156-z.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Related Info
Other Identifiers
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OTA-21-015G
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00112477_A
Identifier Type: -
Identifier Source: org_study_id
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