Protocol for a randomised controlled unblinded feasibility trial of HD-DRUM: a rhythmic movement training application for cognitive and motor symptoms in people with Huntington’s disease

IntroductionHuntington’s disease (HD) is an inherited neurodegenerative disease causing progressive cognitive and motor decline, largely due to basal ganglia (BG) atrophy. Rhythmic training offers promise as therapy to counteract BG-regulated deficits. We have developed HD-DRUM, a tablet-based app t...

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Bibliographic Details
Published in:	BMJ open Vol. 14; no. 7; p. e082161
Main Authors:	Ioakeimidis, Vasileios, Busse, Monica, Drew, Cheney J G, Pallmann, Philip, Watson, Guy B, Jones, Derek, Palombo, Marco, Schubert, Robin, Rosser, Anne E, Metzler-Baddeley, Claudia
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 31-07-2024 BMJ Publishing Group LTD BMJ Publishing Group
Subjects:	Adult Brain research Cognition Consent Disease Exercise Therapy - methods Feasibility Feasibility Studies Female Gamification Humans Huntington Disease - complications Huntington Disease - therapy Huntingtons disease Intervention Magnetic Resonance Imaging Male Mobile Applications Protocol Randomized Controlled Trial Randomized Controlled Trials as Topic Rehabilitation Medicine Rhythm United Kingdom > UK Randomized Controlled Trial Magnetic Resonance Imaging Feasibility Studies
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Summary:	IntroductionHuntington’s disease (HD) is an inherited neurodegenerative disease causing progressive cognitive and motor decline, largely due to basal ganglia (BG) atrophy. Rhythmic training offers promise as therapy to counteract BG-regulated deficits. We have developed HD-DRUM, a tablet-based app to enhance movement synchronisation skills and improve cognitive and motor abilities in people with HD. This paper outlines a randomised controlled unblinded trial protocol to determine the feasibility of a larger effectiveness trial for HD-DRUM. Additionally, the trial investigates cognitive and motor function measures, along with brain microstructure, aiming to advance our understanding of the neural mechanisms underlying training effects.Methods, design and analysis50 individuals with HD, confirmed by genetic testing, and a Total Functional Capacity (TFC) score of 9–13, will be recruited into a two-arm randomised controlled feasibility trial. Consenting individuals with HD will be randomised to the intervention group, which entails 8 weeks of at-home usage of HD-DRUM or a usual-activity control group. All participants will undergo cognitive and motor assessments, alongside ultra-strong gradient (300 mT/m) brain microstructural MRI before and after the 8-week period. The feasibility assessment will encompass recruitment, retention, adherence and acceptability of HD-DRUM following prespecified criteria. The study will also evaluate variations in cognitive and motor performance and brain microstructure changes resulting from the intervention to determine effect size estimates for future sample size calculations.Ethics and disseminationThe study has received favourable ethical opinion from the Wales Research Ethics Committee 2 (REC reference: 22/WA/0147) and is sponsored by Cardiff University (SPON1895-22) (Research Integrity, Governance and Ethics Team, Research & Innovation Services, Cardiff University, second Floor, Lakeside Building, University Hospital of Wales, Cardiff, CF14 4XW). Findings will be disseminated to researchers and clinicians in peer-reviewed publications and conference presentations, and to participants, carers and the general public via newsletters and public engagement activities. Data will be shared with the research community via the Enroll-HD platform.Trial registration numberISRCTN11906973.
Bibliography:	Protocol ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. None declared.
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2023-082161