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Suspend or amend? Randomized controlled trial on neuropsychological rehabilitation for epilepsy: A COVID-19 impact
Shivani Sharma1, Ashima Nehra1, Shivam Pandey2
1Neuropsychology, Neurosciences Centre, 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.
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