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

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

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

Sharma S; Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India.
Nehra A; Neuropsychology, Neurosciences Centre, All India Institute of Medical Sciences, New Delhi, India.
Pandey S; Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
Tripathi M; Department of Nuclear Medicine, All India Institute of Medical Sciences, New Delhi, India.
Srivastava A; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Padma MV; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.
Garg A; Department of Neuroradiology, All India Institute of Medical Sciences, New Delhi, India.
Pandey RM; Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
Chandra S; Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.
Tripathi M; Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.

Epilepsy Behav Rep ; 17: 100516, 2022.

Article in English | MEDLINE | ID: covidwho-1587922

ABSTRACT

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

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: Epilepsy Behav Rep Year: 2022 Document Type: Article Affiliation country: J.ebr.2021.100516

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