High-definition Surface Electromyography Markers for the Diagnosis and Monitoring of Sarcopenia

Official title

Preventing Loss of Autonomy in Older Patients by Improving Diagnosis of Sarcopenia and Monitoring With High-definition Surface Electromyography Technology

Overview

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 project, the high-definition surface electromyography technology (HD-sEMG) signals will be analysed to extract features/ markers for the diagnosis of sarcopenia. This is a multicentric, descriptive, cross-sectional, parallel group study to develop a new diagnostic method. It is planned to include 846 people aged 75 years and over hospitalized in the acute geriatric or rehabilitation wards and suspected of sarcopenia (Score ≥4 on the SARC-F screening questionnaire). The inclusion duration will be 18 months and adding a 3-month patient follow-up. The total study duration will be 21 months. Patients will have their body composition using bioimpedancemetry and if possible by 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.

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 project, the investigators aim to develop an automatic procedure derived from high-definition surface electromyography (HD-sEMG) technology, non-invasive and portable, for the diagnosis of sarcopenia.

Interventions

• Device 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 rises, depending on the patient's functional state
• Device 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

Primary outcome measures

• Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects [Time frame: Day 1- Day 7]

Secondary outcome measures (12)

• HD-sEMG signals associated with functional recovery [Time frame: Day 21 +/-3 days]
• HD-sEMG signals associated with functional recovery [Time frame: Day 90+/-7 days]
• HD-sEMG signals associated with Muscle Mass Index [Time frame: Day 1]
• HD-sEMG signals associated with Muscle Mass Index [Time frame: Day 7]
• HD-sEMG signals associated with grip strength [Time frame: Day 1]
• HD-sEMG signals associated with grip strength [Time frame: Day 7]
• HD-sEMG signals associated with physical performance [Time frame: Day 1]
• HD-sEMG signals associated with physical performance [Time frame: Day 7]
• HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness [Time frame: Day 1]
• HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness [Time frame: Day 7]
• Progress in muscle parameters [Time frame: Day 21 +/-3 days]
• Correlation between muscle parameters and in-hospital complications [Time frame: Day 21 +/-3 days]

Eligibility criteria

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
• 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 <3months
• Pace maker
• Recent fracture or trauma of the preventing dynamic measurement of HD-sEMG recording
• Bilateral hip prosthesis
• Skin problem that may interfere with the recording of surface EMG activity
• Skin allergies to plasters
• Allergies to electrode materials (acrylate)
• Patient under legal protection
• Patient on state medical aid (AME : Aide Médicale d'Etat)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 11 centers

• Hôpital Corentin Celton, APHP — Issy-les-Moulineaux
• Hôpital Corentin Celton, APHP — Issy-les-Moulineaux
• Hôpital Charles Foix, APHP — Ivry-sur-Seine
• Hôpital Charles Foix, APHP — Ivry-sur-Seine
• Hôpital Charles Foix, APHP — Ivry-sur-Seine
• Unité d'Explorations fonctionnelles du sujet âgé - Hôpital Charles Foix — Ivry-sur-Seine
• Hôpital Rothschild, APHP — Paris
• Hôpital Rothschild, APHP — Paris
• … and 3 more centers

Identifiers

NCT: NCT06963359 · APHP240022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗