[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03485040":3,"trial-entities:NCT03485040":94,"trial-summary:NCT03485040":98},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":15,"eligibility_criteria":42,"std_ages":56,"locations":59,"central_contacts":68,"overall_officials":77,"references":82,"see_also_links":93},"NCT03485040","2017P000868","Stroke Motor Rehabilitation and Recovery Study","Defining the Trajectory of Motor Recovery After Stroke","RECRUITING","2027-06-30","2025-05","2025-05-15","2017-06-09","Massachusetts General Hospital","OTHER",false,"SMaHRT (Stroke Motor reHabiliation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic and hemorrhagic stroke.","Participants will be enrolled in the SMaHRT study during their acute stroke hospitalization and will have research visits spanning the post-stroke care continuum at approximately 6 weeks, 3 months, 6 months, one year, two years, and three years after stroke. The study will collect demographics and clinical outcome measures, clinical neuroimages, video and robot-kinematic data and neurophysiology data through TMS and EEG in order to quantify the course of motor recovery. The research visits may be accompanied by a comprehensive clinical visit to the Massachusetts General Hospital Neurorecovery Clinic. The goal is to understand the behavioral, neuroanatomic, and neurophysiologic underpinnings of motor recovery toward developing personalized strategies and neurotechnologies to facilitate neurorehabilitation and enable better recovery for people with stroke.",[19],"Stroke, Ischemic",[21,22,23,24,25],"Rehabilitation","Neurorehabilitation","Neurotechnology","Neurorecovery","Neurorestoration","OBSERVATIONAL",null,[],{"count":30,"type":31},300,"ESTIMATED",[],[34],{"measure":35,"description":36,"timeFrame":37},"Fugl-Meyer Arm Motor Assessment","This test provides information about level of upper extremity motor impairment after stroke. The test includes a series of different movements that allow for the assessment of functional movement capacity and quality. The scale is used to track change in upper extremity motor impairment over the course of one year post stroke.","Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N\u002FA; Time 7: N\u002FA",[],"ALL","18 Years","90 Years",{"inclusion":43,"exclusion":50,"raw_text":55},[44,45,46,47,48,49],"Age 18 - 90","Upper extremity motor weakness after ischemic and\u002For hemorrhagic stroke as defined by a score of \\>=1 on NIH Stroke Scale Arm Motor Drift Questions 5A or 5B","Ability to follow simple commands in English","Score of zero or 1 on the NIH Stroke Scale Level of Consciousness Questions 1a and 1b and a score of zero on the NIH Stroke Scale Level of Consciousness Question 1c.","Stable medical status as determined by primary care team","Inpatient on the MGH stroke neurology service",[51,52,53,54],"Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability","Prior history of visual or auditory disorders limiting ability to participate in testing","Evidence of an uncontrolled seizure disorder","Patients for whom EEG leads are contraindicated","Inclusion Criteria\n\n* Age 18 - 90\n* Upper extremity motor weakness after ischemic and\u002For hemorrhagic stroke as defined by a score of \\>=1 on NIH Stroke Scale Arm Motor Drift Questions 5A or 5B\n* Ability to follow simple commands in English\n* Score of zero or 1 on the NIH Stroke Scale Level of Consciousness Questions 1a and 1b and a score of zero on the NIH Stroke Scale Level of Consciousness Question 1c.\n* Stable medical status as determined by primary care team\n* Inpatient on the MGH stroke neurology service\n\nExclusion Criteria\n\n* Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability\n* Prior history of visual or auditory disorders limiting ability to participate in testing\n* Evidence of an uncontrolled seizure disorder\n* Patients for whom EEG leads are contraindicated",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":13,"status":8,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"Boston","Massachusetts","02114","United States",{"lat":66,"lon":67},42.35843,-71.05977,[69,74],{"name":70,"role":71,"phone":72,"email":73},"Julie A DiCarlo, MS","CONTACT","617-726-1311","jdicarlo2@mgh.harvard.edu",{"name":75,"role":71,"email":76},"Maryam Masood, MSC","mmasood@mgh.harvard.edu",[78],{"name":79,"affiliation":80,"role":81},"David J Lin, MD","Neurologist","PRINCIPAL_INVESTIGATOR",[83,87,90],{"pmid":84,"type":85,"citation":86},"33707402","BACKGROUND","Kline DK, Lin DJ, Cloutier A, Sloane K, Parlman K, Ranford J, Picard-Fraser M, Fox AB, Hochberg LR, Kimberley TJ. Arm Motor Recovery After Ischemic Stroke: A Focus on Clinically Distinct Trajectory Groups. J Neurol Phys Ther. 2021 Apr 1;45(2):70-78. doi: 10.1097\u002FNPT.0000000000000350.",{"pmid":88,"type":85,"citation":89},"33858997","Lin DJ, Erler KS, Snider SB, Bonkhoff AK, DiCarlo JA, Lam N, Ranford J, Parlman K, Cohen A, Freeburn J, Finklestein SP, Schwamm LH, Hochberg LR, Cramer SC. Cognitive Demands Influence Upper Extremity Motor Performance During Recovery From Acute Stroke. Neurology. 2021 May 25;96(21):e2576-e2586. doi: 10.1212\u002FWNL.0000000000011992. Epub 2021 Apr 15.",{"pmid":91,"type":85,"citation":92},"34890840","Kuo YL, Lin DJ, Vora I, DiCarlo JA, Edwards DJ, Kimberley TJ. Transcranial magnetic stimulation to assess motor neurophysiology after acute stroke in the United States: Feasibility, lessons learned, and values for future research. Brain Stimul. 2022 Jan-Feb;15(1):179-181. doi: 10.1016\u002Fj.brs.2021.12.001. Epub 2021 Dec 7. No abstract available.",[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Stroke",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study planning to enroll 300 participants. It is designed to watch and record how people recover naturally after a stroke.","completed","Stroke Motor Rehabilitation and Recovery Study (SMaHRT)","This study, called SMaHRT, aims to understand how people recover arm movement after a stroke (when blood flow to the brain is interrupted, either by a clot or bleeding). Researchers will follow participants over time to learn about the natural recovery process. You might be able to join if you are between 18 and 90 years old, have some arm weakness after an ischemic (clot-related) or hemorrhagic (bleeding-related) stroke, and can follow simple commands in English. The main way success is measured in this study is by tracking your arm movement using a test called the Fugl-Meyer Arm Motor Assessment over approximately one year. The current status of this study is unclear.","Participants will be followed for up to three years after their stroke date.",112,"You would have research visits during your acute hospitalization and then at approximately 6 weeks, 3 months, 6 months, one year, two years, and three years after your stroke. These visits may include collecting demographics, clinical measurements, neuroimages, video, and brain activity data.","Not stated in the trial record.",[],"v2"]