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ArticleTrials2024

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).

David S Knopman, Daniel T Laskowitz, Deborah C Koltai, Leigh E Charvet, Jacqueline H Becker, Alex D Federman, Juan Wisnivesky, Henry Mahncke, Thomas M Van Vleet, Lucinda Bateman and 8 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05965739 (RECOVER-NEURO), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05965739 nacompletednot on this map

RECOVER-NEURO: A Platform Protocol for Evaluation of Interventions for Cognitive Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

TypeinterventionalSponsorDuke UniversityRan2023 to 2024Enrolled328ConditionsLong COVID, Long Covid19, Long Covid-19ArmsBrainHQ/Active Comparator Activity, BrainHQ, PASC CoRE, tDCS-active, tDCS-sham
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. ICU Recovery Interventions: Is It Time for a Personalized Medicine Approach?American journal of respiratory and critical care medicine · 2025
    Article
  6. Review
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

David S Knopman *Mayo Clinic, Rochester, MN, USA. knopman@mayo.edu.ORCID http://orcid.org/0000-0002-6544-066X
Daniel T Laskowitz *Duke Clinical Research Institute, Durham, NC, USA.
Deborah C Koltai *Duke University School of Medicine, Durham, NC, USA.
Leigh E CharvetNew York University Grossman School of Medicine, New York, NY, USA.
Jacqueline H BeckerIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Alex D FedermanIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Juan WisniveskyIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Henry MahnckePosit Science, San Francisco, CA, USA.
Thomas M Van VleetPosit Science, San Francisco, CA, USA.
Lucinda BatemanBateman Horne Center, Salt Lake City, UT, USA.
Dong-Yun KimNational Institutes of Health, Bethesda, MD, USA.
Ashley O'SteenDuke Clinical Research Institute, Durham, NC, USA.
Melissa JamesDuke Clinical Research Institute, Durham, NC, USA.
Adam SilversteinDuke Clinical Research Institute, Durham, NC, USA.
Yuliya LokhnyginaDuke Clinical Research Institute, Durham, NC, USA.
Jennifer RichDuke Clinical Research Institute, Durham, NC, USA.
Bryan J FegerDuke Clinical Research Institute, Durham, NC, USA.
Kanecia O ZimmermanDuke Clinical Research Institute, Durham, NC, USA.

Funding

ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating CenterOT2HL156812 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI NOLEN, TRACY L, THOMAS, SONIA M · 2020 to 2024
$1270.7M
NHLBI NIH HHS OT2 HL156812NIH HHS 1OT2HL156812-01 (OTA-20-011)
6 · The paper itself

Abstract

backgroundPost-acute sequelae of SARS-CoV-2 infection (PASC) symptoms have broad impact, and may affect individuals regardless of COVID-19 severity, socioeconomic status, race, ethnicity, or age. A prominent PASC symptom is cognitive dysfunction, colloquially referred to as "brain fog" and characterized by declines in short-term memory, attention, and concentration. Cognitive dysfunction can severely impair quality of life by impairing daily functional skills and preventing timely return to work.

methodsRECOVER-NEURO is a prospective, multi-center, multi-arm, phase 2, randomized, active-comparator design investigating 3 interventions: (1) BrainHQ is an interactive, online cognitive training program; (2) PASC-Cognitive Recovery is a cognitive rehabilitation program specifically designed to target frequently reported challenges among individuals with brain fog; (3) transcranial direct current stimulation (tDCS) is a noninvasive form of mild electrical brain stimulation. The interventions will be combined to establish 5 arms: (1) BrainHQ; (2) BrainHQ + PASC-Cognitive Recovery; (3) BrainHQ + tDCS-active; (4) BrainHQ + tDCS-sham; and (5) Active Comparator. The interventions will occur for 10 weeks. Assessments will be completed at baseline and at the end of intervention and will include cognitive testing and patient-reported surveys. All study activities can be delivered in Spanish and English. DISCUSSION: This study is designed to test whether cognitive dysfunction symptoms can be alleviated by the use of pragmatic and established interventions with different mechanisms of action and with prior evidence of improving cognitive function in patients with neurocognitive disorder. If successful, results will provide beneficial treatments for PASC-related cognitive dysfunction.

trial registrationClinicalTrials.gov NCT05965739. Registered on July 25, 2023.

Indexed as

Cognitive DysfunctionCOVID-19Post-Acute COVID-19 SyndromeClinical Trials, Phase II as TopicCognitionCognitive Behavioral TherapyHumansMulticenter Studies as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicTranscranial Direct Current StimulationTreatment OutcomeCognitive dysfunctionCognitive rehabilitationCognitive trainingLong-COVIDPost-acute sequelae of SARS-CoV-2 infectiontDCSTranscranial direct current stimulation

Identifiers

PMID38755688
PMCPMC11098733

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.