High-definition Surface Electromyography Markers for the Diagnosis of Sarcopenia (CHRONOS-SARC)

HD-sEMG Markers of Sarcopenia

Sarcopenia is a progressive and generalised skeletal muscle disorder involving the accelerated loss of muscle mass and function that is associated with increased adverse outcomes including falls, functional decline, frailty, and mortality.

In this pilot project, the investigators want to explore the potential of the high-definition surface electromyography technology (HD-sEMG) for the diagnosis of sarcopenia.

This is a monocentric, descriptive, cross-sectional, parallel group study to develop a new diagnostic method.

It is planned to include 50 people aged 75 years and over hospitalized in the acute geriatric ward and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire).

The inclusion duration will be 36 months and adding a 1-month patient follow-up as part of routine care, the total study duration will be 37 months.

Patients will have their body composition (muscle mass, fat mass, and bone mass) using dual X-ray absorptiometry (DEXA). Muscular strength will be assessed by handgrip strength. Physical performance will be assessed. Additional data will be collected from their medical records.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Other: HD-sEMG; Other: - Quadriceps muscle ultrasound; Other: IPAQ Physical Activity Questionnaire.

Detailed Description

The aging of the population is a major public health problem with its multifactorial impact on quality of life and maintenance of autonomy. Unfortunately, one consequence of aging is sarcopenia, which affects the intrinsic and functional properties of muscle. It is a risk factor for loss of autonomy, falls, frailty and is associated with increased mortality.

Sarcopenia is defined as a progressive loss of muscle mass, strength and physical performance. Classically, sarcopenia is assessed by imaging techniques (MRI, DEXA) or bioelectrical impedancemetry for aspects related to the assessment of muscle mass loss. MRI or DEXA are not widely available and/or access is limited.

For functional aspects, grip strength measurements are often used. Currently sarcopenia cannot be diagnosed and evaluated by a single examination, including both the morphological (muscle mass) and functional aspects. Furthermore, several biological markers are associated with muscle mass, strength, and function, but these biomarkers are not specific to skeletal muscle and are weakly associated with clinical goals.

Finally, despite the important interest in assessing the qualitative/functional and quantitative aspect of skeletal muscle in neuromuscular impairment, there is currently no tool that routinely assesses these aspects.

In this context, developing new approaches for non-invasive assessment of sarcopenia, is a major issue. In this pilot project, the investigators aim to develop a medical device derived from high-definition surface electromyography (HD-sEMG) technology, non-invasive and portable, for the diagnosis of sarcopenia.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiyoka KINUGAWA, MD PhD; Phone Number: +331 49 59 47 53; Email: kiyoka.kinugawa@aphp.fr
• Study Contact Backup: Name: Sofiane BOUDAOUD, Pr; Phone Number: +(33) 03 44 23 79 29; Email: sofiane.boudaoud@utc.fr

Study Locations

• France
  • Ivry sur Seine, France, 94205
    • Recruiting
    • Service de soins de suite et de réadaptation Gériatrique 1
    • Contact: Cristiano DONADIO, MD; Email: cristiano.donadio@aphp.fr
  • Ivry-sur-Seine, France, 94205
    • Recruiting
    • Service de gériatrie aigue polyvalente (GAP)
    • Contact: Alexandra Monti, Md; Email: alexandra.monti@aphp.fr
  • Ivry-sur-Seine, France, 94205
    • Recruiting
    • Service de soins de suite et de réadaptation gériatrique 2
    • Contact: Adeline GOURONNEC, MD; Email: adeline.gouronnec@aphp.fr
  • Ivry-sur-Seine, France, 94205
    • Not yet recruiting
    • Unité d'Explorations fonctionnelles du sujet âgé, Hôpital Charles Foix
    • Contact: Kiyoka KINUGAWA, MD PhD; Phone Number: +33 1 49594750; Email: kiyoka.kinugawa@aphp.fr
  • Paris, France, 75012
    • Recruiting
    • Service de soins de suite et de réadaptation -Plaies et cicatrisation
    • Contact: Hester COLBOC, MD; Email: hester.colboc@aphp.fr
  • Paris, France, 75012
    • Recruiting
    • Service de soins de suite et de réadaptation Gériatrique Hôpital Rothschild
    • Contact: Charlotte TOMEO, MD; Email: charlotte.tomeo@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient aged 75 years and over
• Score ≥4 on the SARC-F screening questionnaire
• Enrolled in a social security plan (no AME)
• Informed and consenting patient

Exclusion Criteria:

• BMI ≥30 kg/m2
• Untreated/unbalanced endocrinological pathology
• Myopathy
• Inflammatory or autoimmune pathology
• Severe psychiatric pathology or severe cognitive disorders that do not allow the performance of examinations
• Patients who are dependent for all acts of daily life
• Patients with a very short life expectancy
• Recent fracture or trauma of the lower limbs preventing dynamic measurement of HD-sEMG recording
• Bilateral hip prosthesis
• Skin problem that may interfere with the recording of surface EMG activity
• Patient under guardianship / curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Elderly patients suspected of sarcopenia

Other: HD-sEMG; high definition surface electromyography, allowing the recording of muscle activation signals sensitive to the intensity of the contraction and indirectly to the muscle strength as well as to the muscular fatigability, but also capable of measuring the modifications of the recruitment modalities of the motor units. This recording will be made on the rectus femoris during knee extension, either in the lying position or during chair lifts, depending on the patient's functional state.; Other: - Quadriceps muscle ultrasound; Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed.; Other: IPAQ Physical Activity Questionnaire.; physical activity assessment questionnaire/adapted version for seniors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyographic signals of the rectus femoris collected by the HD-sEMG technique	These signals will be confronted by the diagnosis of sarcopenia defined by the joint presence of the 2 clinical criteria of the European Working Group on Sarcopenia in Older People 2 (EWGSOP2).	day1-day7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months	Information will be collected in the medical record.	day1- day7
Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA		day1-day7
Grip strength by dynamometer (kg)		day1-day7
SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)	Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome	day1-day7
HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG	HD-sEMG parameters will be collected by HD-sEMG technique with TMSi's Mobita equipment, CE marked (European compliance). They will be collected by electrical measurements from a grid of electrodes (32 channels) placed on the muscle surface. The results of the measurement will be represented by a muscle activation mapping.	1 month post inclusion
Rate of Mortality at 1 month	Rate of participants who deceased at 1 month. Mortality will be measured with vital status at 1 month.	1 month post inclusion
Muscle and subcutaneous fat thicknesses of the quadriceps in mm	Muscle and subcutaneous fat thickness of the quadriceps in mm evaluated by ultrasound	day1-day7

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Kiyoka KINUGAWA, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Estimated): May 18, 2025
• Study Completion (Estimated): June 18, 2025

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Sarcopenia; Muscle; High definition surface electromyography; Biphotonic X-ray absorptiometry; Dual x-ray absorptiometry (DEXA)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: APHP201339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No