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BMJ Open: first published as 10.1136/bmjopen-2020-039767 on 11 February 2021. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on October 2, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-039767 on 11 February 2021. Downloaded from Remotely delivered environmental enrichment intervention for traumatic brain injury: A randomised controlled trial Journal: BMJ Open ManuscriptFor ID peerbmjopen-2020-039767 review only Article Type: Protocol Date Submitted by the 27-Apr-2020 Author: Complete List of Authors: Belchev, Zorry; University of Toronto, Psychology; Rotman Research Institute, Boulos, Mary Ellene; University of Toronto, Graduate Department of Rehabilitation Science; Toronto Rehabilitation Institute, KITE Rybkina, Julia; University of Toronto, Graduate Department of Rehabilitation Science; Toronto Rehabilitation Institute, KITE Johns, Kadeen; Toronto Rehabilitation Institute, KITE Jeffay, Eliyas; Rotman Research Institute, ; Toronto Rehabilitation Institute, KITE Colella, Brenda; Toronto Rehabilitation Institute, KITE Ozubko, Jason; State University of New York College at Geneseo, Psychology Bray, Michael; University of Toronto, Graduate Department of Rehabilitation Science; Toronto Rehabilitation Institute, KITE Di Genova, Nicholas; Toronto Rehabilitation Institute, KITE; McMaster http://bmjopen.bmj.com/ University, Computing and Software Levi, Adina; Rotman Research Institute, ; York University, Psychology Changoor, Alana; Toronto Rehabilitation Institute, KITE; McMaster University Faculty of Health Sciences, Global Health Program Worthington, Thomas; Toronto Rehabilitation Institute, KITE; York University, Psychology Gilboa, Asaf; University of Toronto, Psychology; Rotman Research Institute, Green, Robin; Toronto Rehabilitation Institute, KITE; University of on October 2, 2021 by guest. Protected copyright. Toronto, Psychiatry REHABILITATION MEDICINE, Neurological injury < NEUROLOGY, Keywords: THERAPEUTICS For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 51 BMJ Open 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2020-039767 on 11 February 2021. Downloaded from 5 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 37 38 http://bmjopen.bmj.com/ 39 40 41 42 43 44 45 46 on October 2, 2021 by guest. Protected copyright. 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 51 Running head: REMOTE ENRICHMENT IN TBI 1 BMJ Open: first published as 10.1136/bmjopen-2020-039767 on 11 February 2021. Downloaded from 1 2 3 4 5 6 Title: Remotely delivered environmental enrichment intervention for traumatic brain injury: A 7 randomised controlled trial 8 9 Authors: 1,2Belchev, Zorry, 3,4Boulos, Mary E., 3,4Rybkina, Julia, 4Johns, Kadeen, 1,2,4Jeffay, 10 Eliyas, 4Colella, Brenda, 5Ozubko, Jason, 3,4Bray, Michael J. C., 4,6Di Genova, Nicholas, 2,7Levi, 11 Adina, 4,8Changoor, Alana, 4,7Worthington, Thomas, 1,2,4Gilboa, Asaf*, 4,9Green, Robin E.* 12 *Co-senior authors 13 14 15 1Department of Psychology, University of Toronto, Toronto, ON, Canada 16 2Rotman Research InstituteFor at peer Baycrest, Toronto, review ON, Canada only 17 3Graduate Department of Rehabilitation Science, University of Toronto, Toronto, ON, Canada 18 4Toronto Rehabilitation Institute (KITE), Toronto, ON, Canada 19 5Department of Psychology, The State University of New York, Geneseo, NY, USA 20 6 21 Department of Computing and Software, McMaster University, Hamilton, ON, Canada 7 22 Department of Psychology, York University, Toronto, ON, Canada 23 8Global Health Program, Faculty of Health Sciences, McMaster University, Hamilton, ON, 24 Canada 25 9Department of Psychiatry, University of Toronto, ON, Canada 26 27 28 29 Corresponding Author Information: 30 Zorry Belchev 31 (t) 416-785-2500 x3354. (e) [email protected] 32 Rotman Research Institute at Baycrest 33 3460 Bathurst St., North York, Ontario, Canada M6A 2E1 34 http://bmjopen.bmj.com/ 35 Word Count (between Article Summary and Acknowledgments): 4557 36 37 38 39 40 41 42 on October 2, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 51 BMJ Open REMOTE ENRICHMENT IN TBI 2 BMJ Open: first published as 10.1136/bmjopen-2020-039767 on 11 February 2021. Downloaded from 1 2 3 ABSTRACT 4 5 6 Introduction: Individuals with moderate-severe traumatic brain injury (m-sTBI) experience 7 8 progressive brain and behavioural declines in the chronic stages of injury. Longitudinal studies 9 10 found that a majority of m-sTBI patients exhibit significant hippocampal atrophy from 5-12 11 12 months post-injury, associated with decreased cognitive environmental enrichment (EE). 13 14 15 Encouragingly, engaging in EE has been shown to lead to neural improvements, suggesting it is 16 For peer review only 17 a promising avenue for offsetting hippocampal neurodegeneration in m-sTBI. Allocentric spatial 18 19 navigation (i.e., flexible, bird’s eye view approach), is a good candidate for EE in m-sTBI 20 21 22 because it is associated with hippocampal activation and reduced aging-related volume loss. 23 24 Efficacy of EE requires intensive daily training, prohibitive within most current health delivery 25 26 systems. The present protocol is a novel, remotely delivered and self-administered intervention 27 28 29 designed to harness principles from EE and allocentric spatial navigation to offset hippocampal 30 31 atrophy and potentially improve hippocampal functions such as navigation and memory for m- 32 33 sTBI patients. 34 http://bmjopen.bmj.com/ 35 Methods and Analysis: Seventy chronic m-sTBI participants are being recruited from an urban 36 37 38 rehabilitation hospital and randomised into a 16-week intervention (five hours/week; total: 80 39 40 hrs.) of either targeted spatial navigation or an active control group. The spatial navigation group 41 on October 2, 2021 by guest. Protected copyright. 42 engages in structured exploration of different cities using Google Street View that includes daily 43 44 45 navigation challenges. The active control group watches and answers subjective questions about 46 47 educational videos. Following a brief orientation, participants remotely self-administer the 48 49 intervention on their home computer. In addition to feasibility and compliance measures, clinical 50 51 52 and experimental cognitive measures as well as MRI scan data are collected pre- and post- 53 54 intervention to determine behavioural and neural efficacy. 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 51 REMOTE ENRICHMENT IN TBI 3 BMJ Open: first published as 10.1136/bmjopen-2020-039767 on 11 February 2021. Downloaded from 1 2 3 Ethics and Dissemination: Ethics approval has been obtained from ethics boards at the 4 5 6 University Health Network and University of Toronto. Findings will be presented at academic 7 8 conferences and submitted to peer-reviewed journals.
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