Suspend or amend? Randomized controlled trial on neuropsychological rehabilitation for epilepsy: A COVID-19 impact

Shivani Sharma; Ashima Nehra; Shivam Pandey; Madhavi Tripathi; Achal Srivastava; M V Padma; Ajay Garg; R M Pandey; Sarat Chandra; Manjari Tripathi

doi:10.1016/j.ebr.2021.100516

Suspend or amend? Randomized controlled trial on neuropsychological rehabilitation for epilepsy: A COVID-19 impact

Epilepsy Behav Rep. 2022:17:100516. doi: 10.1016/j.ebr.2021.100516. Epub 2021 Dec 16.

Authors

Affiliations

¹ Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India.
² Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
³ Department of Nuclear Medicine, All India Institute of Medical Sciences, New Delhi, India.
⁴ Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
⁵ Department of Neuroradiology, All India Institute of Medical Sciences, New Delhi, India.
⁶ Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.

Abstract

COVID-19 caused devastating effects of human loss and suffering along with disruption in clinical research, forcing reconceptualization and modification of studies. This paper attempts to outline the steps followed and detail the modifications undertaken to deal with the impacts of the pandemic on the first ongoing randomized controlled trial on effectiveness of neuropsychological rehabilitation in adult patients with drug-resistant epilepsy in India. All modifications were based on evolving guidelines and circumstantial context and were planned, reviewed and approved by important stakeholders. Results obtained from the trial need to be interpreted and analysed within this context. These modifications have implications for wider outreach of neuropsychology services in India.

Keywords: BSWP, Biostatistics Working Party; COVID-19; CTRI, Clinical Trials Registry of India; DRE, Drug Resistant Epilepsy; Epilepsy; FGDs, Focus Group Discussions; HIPPA, Health Insurance Portability and Accountability Act; ILAE, International League Against Epilepsy; INS, International Neuropsychological Society; LBT, Lumosity Brain Training; NIH, National Institutes of Health; Neuropsychological rehabilitation; Neuropsychology; RCTS, Randomized Controlled Trials; TMT, Traditional Memory Training; TeleNP, Tele-Neuropsychology; WHO, World Health Organization.