Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT06963359
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-definition Surface Electromyography Markers for the Diagnosis and Monitoring of Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 846}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic score of electromyographic signals from the rectus femoris collected by the HD-sEMG technique, differentiating sarcopenic from non-sarcopenic elderly subjects', 'timeFrame': 'Day 1- Day 7'}], 'secondaryOutcomes': [{'measure': 'HD-sEMG signals associated with functional recovery', 'timeFrame': 'Day 21 +/-3 days', 'description': 'Identify HD-sEMG parameters associated with good functional recovery of autonomy at D21 and M3 of hospitalization (muscle resilience)'}, {'measure': 'HD-sEMG signals associated with functional recovery', 'timeFrame': 'Day 90+/-7 days', 'description': 'Identify HD-sEMG parameters associated with good functional recovery of autonomy at D21 and M3 of hospitalization (muscle resilience)'}, {'measure': 'HD-sEMG signals associated with Muscle Mass Index', 'timeFrame': 'Day 1', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the Muscle Mass Index measured by DEXA or Bioimpedancemetry'}, {'measure': 'HD-sEMG signals associated with Muscle Mass Index', 'timeFrame': 'Day 7', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the Muscle Mass Index measured by DEXA or Bioimpedancemetry'}, {'measure': 'HD-sEMG signals associated with grip strength', 'timeFrame': 'Day 1', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and grip strength measured using manual hydraulic dynamometer'}, {'measure': 'HD-sEMG signals associated with grip strength', 'timeFrame': 'Day 7', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and grip strength measured using manual hydraulic dynamometer'}, {'measure': 'HD-sEMG signals associated with physical performance', 'timeFrame': 'Day 1', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the physical performance measured using Short Physical Performance Battery score (bad physical performance if score ≤ 8).'}, {'measure': 'HD-sEMG signals associated with physical performance', 'timeFrame': 'Day 7', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and the physical performance measured using Short Physical Performance Battery score (bad physical performance if score ≤ 8).'}, {'measure': 'HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness', 'timeFrame': 'Day 1', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and quadriceps muscle and subcutaneous fat thickness measured using portable ultrasound).'}, {'measure': 'HD-sEMG signals associated with quadriceps muscle and subcutaneous fat thickness', 'timeFrame': 'Day 7', 'description': 'Correlation between electromyographic signals from the rectus femoris collected using the HD-sEMG technique and quadriceps muscle and subcutaneous fat thickness measured using portable ultrasound).'}, {'measure': 'Progress in muscle parameters', 'timeFrame': 'Day 21 +/-3 days', 'description': 'Changes in muscle parameters mentioned above, between the D0 and D21.'}, {'measure': 'Correlation between muscle parameters and in-hospital complications', 'timeFrame': 'Day 21 +/-3 days', 'description': 'Study the relationship between muscle parameters and in-hospital complications. (cardiovascular, pulmonary and thromboembolic diseases)'}, {'measure': 'Correlation between muscle parameters and quality of life', 'timeFrame': 'Day 1', 'description': 'Study the relationship between muscle parameters and quality of life measured using EQD5 scale (EuroQol-5D; 0-20: higher scores mean a worse outcome).'}, {'measure': 'Correlation between muscle parameters and quality of life', 'timeFrame': 'Day 21 +/-3 days', 'description': 'Study the relationship between muscle parameters and quality of life measured using EQD5 scale (EuroQol-5D; 0-20: higher scores mean a worse outcome).'}, {'measure': 'Correlation between muscle parameters and quality of life', 'timeFrame': 'Day 90+/-7 days', 'description': 'Study the relationship between muscle parameters and quality of life measured using EQD5 scale (EuroQol-5D; 0-20: higher scores mean a worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High definition surface electromyography', 'Sarcopenia', 'Muscle'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient aged 75 years and over\n* Score ≥4 on the SARC-F screening questionnaire\n* Enrolled in a social security plan (no AME)\n* Informed and consenting patient\n\nExclusion Criteria:\n\n* BMI ≥30 kg/m2\n* Severe psychiatric pathology or severe cognitive disorders that do not allow the performance of examinations\n* Patients who are dependent for all acts of daily life\n* Patients with a very short life expectancy \\<3months\n* Pace maker\n* Recent fracture or trauma of the preventing dynamic measurement of HD-sEMG recording\n* Bilateral hip prosthesis\n* Skin problem that may interfere with the recording of surface EMG activity\n* Skin allergies to plasters\n* Allergies to electrode materials (acrylate)\n* Patient under legal protection\n* Patient on state medical aid (AME : Aide Médicale d'Etat)"}, 'identificationModule': {'nctId': 'NCT06963359', 'acronym': 'CHRONOSSARCRE', 'briefTitle': 'High-definition Surface Electromyography Markers for the Diagnosis and Monitoring of Sarcopenia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Preventing Loss of Autonomy in Older Patients by Improving Diagnosis of Sarcopenia and Monitoring With High-definition Surface Electromyography Technology', 'orgStudyIdInfo': {'id': 'APHP240022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elderly patients suspected of sarcopenia', 'interventionNames': ['Device: HD-sEMG', 'Device: Quadriceps muscle ultrasound', 'Other: IPAQ Physical Activity Questionnaire']}], 'interventions': [{'name': 'HD-sEMG', 'type': 'DEVICE', 'description': "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", 'armGroupLabels': ['Elderly patients suspected of sarcopenia']}, {'name': 'Quadriceps muscle ultrasound', 'type': 'DEVICE', 'description': "Muscle Ultrasound with Philips Lumify Wireless Handheld Ultrasound for Android - Model - L12-4 linear probe, allowing performance at the patient's bed", 'armGroupLabels': ['Elderly patients suspected of sarcopenia']}, {'name': 'IPAQ Physical Activity Questionnaire', 'type': 'OTHER', 'description': 'Physical activity assessment questionnaire/adapted version for seniors', 'armGroupLabels': ['Elderly patients suspected of sarcopenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92130', 'city': 'Issy-les-Moulineaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Johanne Poisson, MD-PhD', 'role': 'CONTACT', 'email': 'johanne.poisson@aphp.fr', 'phone': '0158004802'}], 'facility': 'Hôpital Corentin Celton, APHP', 'geoPoint': {'lat': 48.82104, 'lon': 2.27718}}, {'zip': '94205', 'city': 'Ivry-sur-Seine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandra Monti, MD, PhD', 'role': 'CONTACT', 'email': 'alexandra.monti@aphp.fr', 'phone': '01 49 59 44 91'}], 'facility': 'Hôpital Charles Foix, APHP', 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}, {'zip': '94205', 'city': 'Ivry-sur-Seine', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Kiyoka KINUGAWA, Prof. MD PhD', 'role': 'CONTACT', 'email': 'kiyoka.kinugawa@aphp.fr', 'phone': '+331 49 59 47 53'}], 'facility': "Unité d'Explorations fonctionnelles du sujet âgé - Hôpital Charles Foix", 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Sophie Grancher, MD-PhD', 'role': 'CONTACT', 'email': 'anne-sophie.grancher@aphp.fr', 'phone': '0140 19 33 94'}], 'facility': 'Hôpital Rothschild, APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hester Colboc, MD-PhD', 'role': 'CONTACT', 'email': 'hester.colboc@aphp.fr', 'phone': '0603611623'}], 'facility': 'Hôpital Rothschild, APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Audrey Rouet, MD-PhD', 'role': 'CONTACT', 'email': 'audrey.rouet@aphp.fr', 'phone': '0156017253'}], 'facility': 'Hôpital Tenon, APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Kiyoka KINUGAWA, Prof. MD PhD', 'role': 'CONTACT', 'email': 'kiyoka.kinugawa@aphp.fr', 'phone': '+331 49 59 47 53'}, {'name': 'Sofiane BOUDAOUD, Prof. PhD', 'role': 'CONTACT', 'email': 'sofiane.boudaoud@utc.fr', 'phone': '+(33) 03 44 23 79 29'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "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.\n\nConsultation 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.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Compiègne University of Technology', 'class': 'UNKNOWN'}, {'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}