Evaluation of Interventions for Cognitive Symptoms in Long COVID: A Randomized Clinical Trial.
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Knopman David S, Koltai Deborah, Laskowitz Daniel T, Becker Jacqueline, Charvet Leigh, Wisnivesky Juan, Federman Alex, Silverstein Adam, Lokhnygina Yuliya, Pilloni Giuseppina, Haddad Michelle, Mahncke Henry, Van Vleet Tom, Huang Rong, Cox Wendy, Terry Diana, Karwowski Jeannie, McCray Netia, Lin Jenny J, McComsey Grace A, Singh Upinder, Geng Linda N, Chu Helen Y, Reece Rebecca, Moy James, Arvanitakis Zoe, Parthasarathy Sairam, Patterson Thomas F, Gupta Aditi, Ostrosky-Zeichner Luis, Parsonnet Jeffrey, Kiriakopoulos Elaine T, Fong Tamara G, Mullington Janet, Jolley Sarah, Shah Nirav S, Morimoto Sarah Shizuko, Lee-Iannotti Joyce K, Killgore William D S, Dwyer Brigid, Stringer William, Isache Carmen, Frontera Jennifer A, Krishnan Jerry A, O'Steen Ashley, James Melissa, Harper Barrie L, Zimmerman Kanecia O, RECOVER-NEURO Clinical Trial Group
Аннотация
OBJECTIVE: To test evidence-based rehabilitation strategies for improving cognitive symptoms in persons with long COVID.
DESIGN, SETTING, AND PARTICIPANTS: This was a 5-arm, multicenter, randomized clinical trial of 3 remotely delivered interventions conducted between August 17, 2023, and June 10, 2024. The study took place at 22 trial sites and included the screening of individuals with cognitive long COVID.
INTERVENTIONS: Participants were randomized to 1 of 5 arms: adaptive computerized cognitive training (BrainHQ [Posit Science]), cognitive-behavioral rehabilitation involving both group and individual counseling sessions (PASC-Cognitive Recovery [PASC-CoRE]) paired with BrainHQ, and transcranial direct current stimulation (tDCS) paired with BrainHQ. Two comparator arms were included as follows: unstructured computer puzzles and games (active comparator) and sham tDCS paired with BrainHQ. The interventions occurred 5 times per week over 10 weeks.
MAIN OUTCOMES AND MEASURES: Cognitive and behavioral in-person assessments were performed at baseline, midintervention, at the end of intervention, and 3 months after the end of the intervention. The primary outcome measure was the modified Everyday Cognition Scale 2 (ECog2) completed at the end of the intervention compared to the baseline visit based on participant self-report looking back over the prior 7 days.
RESULTS: A total of 378 individuals were screened, from which there were 328 participants (median [IQR] age, 48.0 [37.0-58.0] years; 241 female [73.5%]; race: 15 Asian [4.6%], 47 Black [14.3%], and 235 White [71.6%]; ethnicity: 52 Hispanic [15.9%]). None of the 3 active interventions demonstrated benefits on the modified ECog2 in the intention-to-treat population by the end of the intervention period. The adjusted differences in mean change were 0.0 (95% CI, -0.2 to 0.2) for BrainHQ vs active comparator, 0.1 (95% CI, -0.1 to 0.3) for PASC-CoRE + BrainHQ vs active comparator, 0.0 (95% CI, -0.2 to 0.2) for tDCS-active + BrainHQ vs tDCS-sham + BrainHQ, and 0.1 (95% CI, -0.1 to 0.3) for PASC-CoRE + BrainHQ vs BrainHQ alone. Secondary participant-reported outcomes and neuropsychological tests showed no differential benefits for any treatment arm. All 5 arms demonstrated some improvements over time on the modified ECog2 and on secondary outcomes. There were no serious adverse events attributable to the interventions.
CONCLUSIONS AND RELEVANCE: This phase 2 randomized clinical trial failed to demonstrate differential benefits for online cognitive training, a structured cognitive rehabilitation program, and tDCS for cognitive long COVID.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05965739.