[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02567136":3,"trial-entities:NCT02567136":77,"trial-summary:NCT02567136":80},{"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":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":36,"healthy_volunteers":37,"eligibility_criteria":38,"std_ages":49,"locations":52,"central_contacts":70,"overall_officials":73,"references":75,"see_also_links":76},"NCT02567136","130126","Imaging Biomarkers in ALS","A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)","RECRUITING","2031-09-30","2025-11","2025-12-02","2015-09","University of Minnesota","OTHER",false,"The purpose of the study is to determine if we are able to find one or more biomarkers of Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker is a measurable characteristic that can be used as an indicator of a particular disease state. Identifying biomarkers of a disease can lead to a better understanding of the disease as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy controls.",null,[19,20],"Amyotrophic Lateral Sclerosis","Primary Lateral Sclerosis",[],"OBSERVATIONAL",[],{"count":25,"type":26},30,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Imaging biomarkers","Comparison of neurochemical concentrations and Diffusion Tensor Imaging (DTI) parameters between ALS subjects and age-matched normal subjects.","12 months",[],"ALL","21 Years","75 Years",true,{"inclusion":39,"exclusion":43,"raw_text":48},[40,41,42],"21 to 75 years of age inclusive.","Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).","A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.",[44,45,46,47],"Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).","Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.","Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.","The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.","Inclusion Criteria:\n\n* 21 to 75 years of age inclusive.\n* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).\n\nALS patients:\n\n* A clinical diagnosis of possible, laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria.\n\nExclusion Criteria:\n\n* Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).\n* Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.\n* Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs, or in the opinion of the investigator, if there is a strong likelihood that the subject would not be able to lie flat comfortably for 75-90 minutes.\n* The subject requires assistance to ambulate OR climb stairs, unless in the opinion of the investigator, and based upon the subject's rate of disease progression, the subject is likely to be able to participate in the MRI screening 12 months after enrollment.",[50,51],"ADULT","OLDER_ADULT",[53],{"facility":13,"status":8,"city":54,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":67},"Minneapolis","Minnesota","55414","United States",[59,64],{"name":60,"role":61,"phone":62,"email":63},"Valerie Ferment","CONTACT","612-301-1535","ferm0016@umn.edu",{"name":65,"role":66},"David Walk, MD","PRINCIPAL_INVESTIGATOR",{"lat":68,"lon":69},44.97997,-93.26384,[71],{"name":60,"role":61,"phone":72,"email":63},"6123011535",[74],{"name":65,"affiliation":13,"role":66},[],[],{"nct_id":4,"conditions":78,"biomarkers":79},[19,20],[],{"nct_id":4,"found":37,"summary":81,"prompt_version":91},{"design":82,"status":83,"heading":84,"summary":85,"follow_up":86,"word_count":87,"commitments":88,"compensation":89,"drugs_mentioned":90},"This is an observational study, meaning participants will be monitored without receiving a specific intervention. It plans to enroll 30 participants, including those with ALS, PLS, and healthy controls.","completed","Imaging Biomarkers in ALS and PLS","This study aims to find indicators (biomarkers) for Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using special MRI scans. Researchers will use two types of MRI scans (3T and 7T) to see if they can identify characteristics that help us better understand these diseases and potentially lead to improved treatments. You may be able to join if you are between 21 and 75 years old and have a diagnosis of ALS or PLS. The study will also include healthy volunteers. Success will be measured by identifying these imaging biomarkers at 12 months.","The primary goal is to measure imaging biomarkers at 12 months.",94,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]