[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05104710":3,"trial-entities:NCT05104710":136,"trial-summary:NCT05104710":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":15,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":54,"locations":57,"central_contacts":119,"overall_officials":124,"references":127,"see_also_links":132},"NCT05104710","IRB20-1478","Intermuscular Coherence as a Biomarker for ALS","Intermuscular Coherence: A Biomarker for Early Diagnosis and Follow-up of ALS","RECRUITING","2026-12-31","2026-02","2026-02-09","2021-03-31","University of Chicago","OTHER",null,"The specific aims of this study are to:\n\n1. Determine if a painless and quick measurement of muscle activity using surface electrodes can help with the diagnosis of ALS. Specifically, we ask if a measure of intermuscular coherence (IMC-βγ), when added to current diagnostic criteria (Awaji criteria), can differentiate ALS from mimic diseases more accurately and earlier than currently possible.\n2. Characterize IMC-βγ in neurotypical subjects by age, sex, race, and ethnicity.\n3. Follow a cohort of ALS patients longitudinally to determine if IMC-βγ changes with ALS disease progression and whether such changes correlate with functional and clinical scores, or survival.","Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease caused by neuronal death in the motor system, both in the brain and spinal cord. It results in progressive weakness throughout the body, and typically leads to respiratory failure 3-5 years after symptom onset. Therapy initiation and drug development are hindered, in part, by the lack of objective disease markers.\n\nThis is a multi-center trial to validate a potential biomarker for ALS, known as intermuscular coherence (IMC-βγ). IMC measures the correlation in the activity of two muscles during a simple motor task. In a preliminary study we found that patients with ALS have lower IMC than do control subjects. Because measuring IMC is quick, non-invasive, painless, and only requires equipment readily available in standard clinical neurophysiology labs, if validated it would be an important biomarker for ALS.",[19],"Amyotrophic Lateral Sclerosis",[21],"ALS","OBSERVATIONAL",[],{"count":25,"type":26},650,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Change in the sensitivity for diagnosing ALS when a measure of intermuscular coherence is added to the Awaji criteria.","Aim 1 asks if incorporation of IMC-βγ into the Awaji criteria improves the criteria's sensitivity for diagnosing ALS.","5 years",[34,37],{"measure":35,"description":36,"timeFrame":32},"Time to diagnosis of ALS","Aim 1 asks if incorporation of IMC-βγ into the Awaji criteria reduces the time to diagnosis of ALS.",{"measure":38,"description":39,"timeFrame":32},"Rate of ALS disease progression","Aim 3 asks whether changes in the magnitude of IMC-βγ measured over many months varies with ALS disease progression in patients.","ALL","20 Years","90 Years",true,{"inclusion":45,"exclusion":49,"raw_text":53},[46,47,48],"AIM 1: Patients with arm or leg weakness, spastic gait, muscle wasting and\u002For fasciculations (muscle twitching), dysphagia (difficulty swallowing), dysarthria (difficulty speaking), shortness of breath, hyperreflexia or pathological reflexes, or findings of muscle denervation in previous needle electromyography (EMG) studies.","AIM 2: Subjects between 20 and 90 years of age.","AIM 3: Subjects will be selected from among Aim 1 patients who carry an Awaji (without IMC) category of Possible, Probable, or Definite ALS.",[50,51,52],"AIM 1:","AIM 2:","AIM 3:","Inclusion Criteria:\n\n* AIM 1: Patients with arm or leg weakness, spastic gait, muscle wasting and\u002For fasciculations (muscle twitching), dysphagia (difficulty swallowing), dysarthria (difficulty speaking), shortness of breath, hyperreflexia or pathological reflexes, or findings of muscle denervation in previous needle electromyography (EMG) studies.\n* AIM 2: Subjects between 20 and 90 years of age.\n* AIM 3: Subjects will be selected from among Aim 1 patients who carry an Awaji (without IMC) category of Possible, Probable, or Definite ALS.\n\nExclusion Criteria:\n\n* AIM 1:\n\n  1. Classified as probable or definite ALS by Awaji criteria prior to initial study evaluation\n  2. Have significant sensory loss in the weak or spastic limbs\n  3. Have significant musculoskeletal or neuropathic pain\n  4. Have an inability or are unwilling to provide informed consent\n  5. Are unable to perform the study-related task\n  6. Are taking baclofen or benzodiazepines\n  7. Have a known non-ALS cause for symptoms\n* AIM 2:\n\n  1. Have a history of neurological disorders such as stroke, neuropathy, or myopathy\n  2. Have significant pain or sensory loss\n  3. Are taking baclofen or sedatives such as benzodiazepines\n  4. Lack of cognitive ability or willingness to provide informed consent\n* AIM 3:\n\n  1. Were unclassified according to the Awaji category or had a defined ALS mimic\n  2. Are taking baclofen, sedatives or benzodiazepines.\n\nNOTE: Participation in a therapeutic clinical trial is NOT an exclusion criterion since this study would not interfere with any potential interventions.",[55,56],"ADULT","OLDER_ADULT",[58,68,85,100],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"University of California Center for Clinical Research","ACTIVE_NOT_RECRUITING","Irvine","California","92697","United States",{"lat":66,"lon":67},33.66946,-117.82311,{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":64,"contacts":73,"geoPoint":82},"University of Miami Miller School of Medicine","Miami","Florida","33136",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Milagros Rodriguez","CONTACT","305-243-6725","mxr2872@med.miami.edu",{"name":80,"role":81},"Nathan Carrbery, MD","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},25.77427,-80.19366,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":64,"contacts":90,"geoPoint":97},"Massachusetts General Hospital","Boston","Massachusetts","02114",[91,95],{"name":92,"role":76,"phone":93,"email":94},"Sravan Mandepudi","617-643-6036","smandepudi@mgh.harvard.edu",{"name":96,"role":81},"Doreen A Ho, MD",{"lat":98,"lon":99},42.35843,-71.05977,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":64,"contacts":105,"geoPoint":116},"Washington University Medical Center","St Louis","Missouri","63110",[106,110,114],{"name":107,"role":76,"phone":108,"email":109},"Kelly McCoy-Gross","314-273-8215","kmccoygross@wustl.edu",{"name":111,"role":76,"phone":112,"email":113},"Bethany Gannon","(314) 273-1686","bgannon@wustl.edu",{"name":115,"role":81},"Sean S Smith, MD",{"lat":117,"lon":118},38.62727,-90.19789,[120],{"name":121,"role":76,"phone":122,"email":123},"Serdar Aydin, MD","(773)795-9908","serdarmd@bsd.uchicago.edu",[125],{"name":126,"affiliation":13,"role":81},"Kourosh Rezania, MD",[128],{"pmid":129,"type":130,"citation":131},"27699797","RESULT","Issa NP, Frank S, Roos RP, Soliven B, Towle VL, Rezania K. Intermuscular coherence in amyotrophic lateral sclerosis: A preliminary assessment. Muscle Nerve. 2017 Jun;55(6):862-868. doi: 10.1002\u002Fmus.25426. Epub 2017 Feb 3.",[133],{"label":134,"url":135},"Intermuscular coherence in amyotrophic lateral sclerosis: A preliminary assessment","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F27699797\u002F",{"nct_id":4,"conditions":137,"biomarkers":138},[19],[],{"nct_id":4,"found":43,"summary":140,"prompt_version":150},{"design":141,"status":142,"heading":143,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an observational study planning to enroll 650 participants. It is not testing a specific drug or intervention.","completed","Observational Study on Intermuscular Coherence as a Biomarker for ALS","This study is looking for a new, easier way to diagnose Amyotrophic Lateral Sclerosis (ALS) earlier and more accurately. Researchers are investigating a measurement called intermuscular coherence (IMC-βγ), which checks the connection between muscle activities using painless surface electrodes. They want to see if adding IMC-βγ to current diagnostic methods (Awaji criteria) can better tell ALS apart from other conditions. The study also aims to understand how IMC-βγ changes as ALS progresses and if these changes relate to how the disease affects daily life or survival. You might be able to join if you are between 20 and 90 years old and have symptoms like arm or leg weakness, muscle twitching, or difficulty swallowing or speaking. The goal is to see if IMC-βγ can become an important, objective marker for ALS.","Participants will be followed for changes in intermuscular coherence over 5 years.",131,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]