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NCT Number: NCT04987814

High-definition Surface Electromyography Markers for the Diagnosis 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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de gériatrie aigue polyvalente (GAP), Ivry-sur-Seine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HD-sEMG

Other

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.

- Quadriceps muscle ultrasound

Other

Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed.

IPAQ Physical Activity Questionnaire.

Other

physical activity assessment questionnaire/adapted version for seniors

Primary outcomes

  1. Electromyographic signals of the rectus femoris collected by the HD-sEMG technique

    Time frame: day1-day7

    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).

Secondary outcomes

  1. Number of participants with falls. Definition of " fallers " : at least 1 fall in the last 12 months

    Time frame: day1- day7

    Information will be collected in the medical record.

  2. Skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2) collected by DEXA

    Time frame: day1-day7

  3. Grip strength by dynamometer (kg)

    Time frame: day1-day7

  4. SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)

    Time frame: day1-day7

    Short Physical Performance Battery (SPPB): score range 0-12, higher score means a better outcome

  5. HD-sEMG muscle data, measured during lower limb quadriceps extension by High Definition Surface Electromyography HD-sEMG

    Time frame: 1 month post inclusion

    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.

  6. Rate of Mortality at 1 month

    Time frame: 1 month post inclusion

    Rate of participants who deceased at 1 month. Mortality will be measured with vital status at 1 month.

  7. Muscle and subcutaneous fat thicknesses of the quadriceps in mm

    Time frame: day1-day7

    Muscle and subcutaneous fat thickness of the quadriceps in mm evaluated by ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Kiyoka KINUGAWA, MD PhD

CONTACT

[email protected]

+331 49 59 47 53

Sofiane BOUDAOUD, Pr

CONTACT

[email protected]

+(33) 03 44 23 79 29

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

HD-sEMG Markers of Sarcopenia

Acronym: CHRONOS-SARC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2021
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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