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Pilipenko Pavel, View ORCID ProfileAnna Ivanova, Julia Kotsubinskaya, Vera Grigoryeva, View ORCID ProfileAlexey Khrulev, Anatoly Skorokhodov, Maxim Gavrik, Marek Majdan, Peter Valkovic, Daria Babarova, Suzanne Barker-Collo, Kelly Jones, View ORCID ProfileValery L. Feigin
doi: https://doi.org/10.1101/2024.08.28.24312757
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Abstract
Introduction: About half of the world population will suffer from a traumatic brain injury (TBI) during their lifetime, of which about 90% of cases are mild TBI. About 15-40% of adults with TBI experience persistent cognitive deficits, and there is a lack of proven-effective treatment to facilitate cognitive recovery after mild TBI.Methods and analysis: This randomized placebo-controlled multi-centre clinical trial aimed to examine the safety and efficacy of herbal supplement MLC901 (NeuroAiD IITM) on cognitive functioning following mild TBI. Adults aged 18-65 years, who were 1-12-months post-mild TBI and experienced cognitive impairment, were assigned to receive either MLC901 (0.8g capsules/day) or placebo for 6 months in 7 research centres in Russia using centralized stratified permuted block randomization. The primary outcome was cognitive functioning as assessed by an online neuropsychological test (CNS Vital signs). Secondary outcomes included Rivermead Post-Concussion Symptoms Questionnaire (RPQ; neurobehavioral sequelae), Health Related Quality of Life (QOLIBRI), the Hospital Anxiety and Depression Scale (HADS), and adverse events. Assessments were completed at baseline and 3-, 6-, and 9-month follow-ups. Mixed effects models of repeated measures with intention to treat analysis were employed, with the primary outcome time-point of 6-months. A Least Square Mean Difference (LSMD) from baseline to 3-, 6-, and 9-month follow-up was calculated with 95% confidence intervals (CI).Results : One hundred and eighty-two participants (mean age 40.6±14.2 in the MLC901 group and 40.1±12.0 in the Placebo group, 50% and 47.8% females, respectively) were included in the analysis. Baseline variables were comparable between groups. Multivariate mixed effects model analysis did not reveal significant improvements in complex attention (LSMD=-1.18 [95% CI -5.40; 3.03; p=0.58] and other cognitive domains at 6-months in the MLC901 group compared to the Placebo group. There were significant improvements in RPQ, QOLIBRI, anxiety and depression in the MLC901 group compared to the Placebo group at 6 and 9-months (LSMD -4.36 [-6.46; -2.26] and -4.07 [-6.22; -1.92], 4.84 [1.58; 8.10] and 3.74 [044; 7.03], -1.50 [-2.29; -0.71 and -0.96 [-1.84; -0.08], -1.14 [-1.92; -0.35] and -1.14 [-1.94; -0.34], respectively. No serious adverse events were reported.Conclusions : The 6-month treatment with MLC901 did not result in a statistically significant difference with placebo for CNS-VS measurement of complex attention and other cognitive outcomes in individuals with mild TBI. The study showed a clinically and statistically significant improvement in all clinical scales assessed by the investigators (post-concussion symptoms, quality of life, and mood). This study showed that post-mild TBI treatment with MLC901 0.8g/day is safe.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
NCT04861688
Funding Statement
The author(s) received no specific funding for this work.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics Committee of the Ministry of Health of the Russian Federation on 9 March 2021 (Dossier Ref#58074, meeting’s protocol #268) and all local Ethics Committees
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data Availability
All relevant data are within the manuscript and its Supporting Information files.
Copyright
The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license.
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PostedAugust 29, 2024.
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