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The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis

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The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis. / Kelly, Madeline; Lavrov, Arseniy; Garcia-Gancedo, Luis; Parr, Jim; Hart, Robert; Chiwera, Theresa; Shaw, Christopher E; Al-Chalabi, Ammar; Marsden, Rachael; Turner, Martin R; Talbot, Kevin.

In: Amyotrophic lateral sclerosis & frontotemporal degeneration, 23.06.2020, p. 1-11.

Research output: Contribution to journalArticle

Harvard

Kelly, M, Lavrov, A, Garcia-Gancedo, L, Parr, J, Hart, R, Chiwera, T, Shaw, CE, Al-Chalabi, A, Marsden, R, Turner, MR & Talbot, K 2020, 'The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis', Amyotrophic lateral sclerosis & frontotemporal degeneration, pp. 1-11. https://doi.org/10.1080/21678421.2020.1773501

APA

Kelly, M., Lavrov, A., Garcia-Gancedo, L., Parr, J., Hart, R., Chiwera, T., ... Talbot, K. (2020). The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis & frontotemporal degeneration, 1-11. https://doi.org/10.1080/21678421.2020.1773501

Vancouver

Kelly M, Lavrov A, Garcia-Gancedo L, Parr J, Hart R, Chiwera T et al. The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis. Amyotrophic lateral sclerosis & frontotemporal degeneration. 2020 Jun 23;1-11. https://doi.org/10.1080/21678421.2020.1773501

Author

Kelly, Madeline ; Lavrov, Arseniy ; Garcia-Gancedo, Luis ; Parr, Jim ; Hart, Robert ; Chiwera, Theresa ; Shaw, Christopher E ; Al-Chalabi, Ammar ; Marsden, Rachael ; Turner, Martin R ; Talbot, Kevin. / The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis. In: Amyotrophic lateral sclerosis & frontotemporal degeneration. 2020 ; pp. 1-11.

Bibtex Download

@article{18b5bf9ff8974ad08d9d9f6a43a659ba,
title = "The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis",
abstract = "Objective: To explore novel, real-world biotelemetry disease progression markers in patients with amyotrophic lateral sclerosis (ALS) and to compare with clinical gold-standard measures. Methods: This was an exploratory, non-controlled, non-drug 2-phase study comprising a variable length Pilot Phase (n = 5) and a 48-week Core study Phase (n = 25; NCT02447952). Patients with mild or moderate ALS wore biotelemetry sensors for ∼3 days/month at home, measuring physical activity, heart rate variability (HRV), and speech over 48 weeks. These measures were assessed longitudinally in relation to ALS Functional Rating Scale-Revised (ALSFRS-R) score and forced vital capacity (FVC); assessed by telephone [monthly] and clinic visits [every 12 weeks]). Results: Pilot Phase data supported progression into the Core Phase, where a decline in physical activity from baseline followed ALS progression as measured by ALSFRS-R and FVC. Four endpoints showed moderate or strong between-patient correlations with ALSFRS-R total and gross motor domain scores (defined as a correlation coefficient of ≥0.5 or >0.7, respectively): average daytime active; percentage of daytime active; total daytime activity score; total 24-hour activity score. Moderate correlations were observed between speech endpoints and ALSFRS-R bulbar domain scores; HRV data quality was insufficient for reliable assessment. The sensor was generally well tolerated; 6/25 patients reported mostly mild or moderate intensity skin and subcutaneous tissue disorder adverse events. Conclusions: Biotelemetry measures of physical activity in this Pilot Study tracked ALS progression over time, highlighting their potential as endpoints for future clinical trials. A larger, formally powered study is required to further support activity endpoints as novel disease progression markers.",
keywords = "Clinical trials, biomarker, epidemiology",
author = "Madeline Kelly and Arseniy Lavrov and Luis Garcia-Gancedo and Jim Parr and Robert Hart and Theresa Chiwera and Shaw, {Christopher E} and Ammar Al-Chalabi and Rachael Marsden and Turner, {Martin R} and Kevin Talbot",
year = "2020",
month = "6",
day = "23",
doi = "10.1080/21678421.2020.1773501",
language = "English",
pages = "1--11",
journal = "Amyotrophic lateral sclerosis & frontotemporal degeneration",
issn = "2167-8421",
publisher = "Taylor & Francis",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - The use of biotelemetry to explore disease progression markers in amyotrophic lateral sclerosis

AU - Kelly, Madeline

AU - Lavrov, Arseniy

AU - Garcia-Gancedo, Luis

AU - Parr, Jim

AU - Hart, Robert

AU - Chiwera, Theresa

AU - Shaw, Christopher E

AU - Al-Chalabi, Ammar

AU - Marsden, Rachael

AU - Turner, Martin R

AU - Talbot, Kevin

PY - 2020/6/23

Y1 - 2020/6/23

N2 - Objective: To explore novel, real-world biotelemetry disease progression markers in patients with amyotrophic lateral sclerosis (ALS) and to compare with clinical gold-standard measures. Methods: This was an exploratory, non-controlled, non-drug 2-phase study comprising a variable length Pilot Phase (n = 5) and a 48-week Core study Phase (n = 25; NCT02447952). Patients with mild or moderate ALS wore biotelemetry sensors for ∼3 days/month at home, measuring physical activity, heart rate variability (HRV), and speech over 48 weeks. These measures were assessed longitudinally in relation to ALS Functional Rating Scale-Revised (ALSFRS-R) score and forced vital capacity (FVC); assessed by telephone [monthly] and clinic visits [every 12 weeks]). Results: Pilot Phase data supported progression into the Core Phase, where a decline in physical activity from baseline followed ALS progression as measured by ALSFRS-R and FVC. Four endpoints showed moderate or strong between-patient correlations with ALSFRS-R total and gross motor domain scores (defined as a correlation coefficient of ≥0.5 or >0.7, respectively): average daytime active; percentage of daytime active; total daytime activity score; total 24-hour activity score. Moderate correlations were observed between speech endpoints and ALSFRS-R bulbar domain scores; HRV data quality was insufficient for reliable assessment. The sensor was generally well tolerated; 6/25 patients reported mostly mild or moderate intensity skin and subcutaneous tissue disorder adverse events. Conclusions: Biotelemetry measures of physical activity in this Pilot Study tracked ALS progression over time, highlighting their potential as endpoints for future clinical trials. A larger, formally powered study is required to further support activity endpoints as novel disease progression markers.

AB - Objective: To explore novel, real-world biotelemetry disease progression markers in patients with amyotrophic lateral sclerosis (ALS) and to compare with clinical gold-standard measures. Methods: This was an exploratory, non-controlled, non-drug 2-phase study comprising a variable length Pilot Phase (n = 5) and a 48-week Core study Phase (n = 25; NCT02447952). Patients with mild or moderate ALS wore biotelemetry sensors for ∼3 days/month at home, measuring physical activity, heart rate variability (HRV), and speech over 48 weeks. These measures were assessed longitudinally in relation to ALS Functional Rating Scale-Revised (ALSFRS-R) score and forced vital capacity (FVC); assessed by telephone [monthly] and clinic visits [every 12 weeks]). Results: Pilot Phase data supported progression into the Core Phase, where a decline in physical activity from baseline followed ALS progression as measured by ALSFRS-R and FVC. Four endpoints showed moderate or strong between-patient correlations with ALSFRS-R total and gross motor domain scores (defined as a correlation coefficient of ≥0.5 or >0.7, respectively): average daytime active; percentage of daytime active; total daytime activity score; total 24-hour activity score. Moderate correlations were observed between speech endpoints and ALSFRS-R bulbar domain scores; HRV data quality was insufficient for reliable assessment. The sensor was generally well tolerated; 6/25 patients reported mostly mild or moderate intensity skin and subcutaneous tissue disorder adverse events. Conclusions: Biotelemetry measures of physical activity in this Pilot Study tracked ALS progression over time, highlighting their potential as endpoints for future clinical trials. A larger, formally powered study is required to further support activity endpoints as novel disease progression markers.

KW - Clinical trials

KW - biomarker

KW - epidemiology

UR - http://www.scopus.com/inward/record.url?scp=85087341059&partnerID=8YFLogxK

U2 - 10.1080/21678421.2020.1773501

DO - 10.1080/21678421.2020.1773501

M3 - Article

C2 - 32573278

SP - 1

EP - 11

JO - Amyotrophic lateral sclerosis & frontotemporal degeneration

JF - Amyotrophic lateral sclerosis & frontotemporal degeneration

SN - 2167-8421

ER -

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