[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Pins Medical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,74,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100650254","spinal-cord-stimulation-for-poststroke-spasticity-100650254",false,"NCT07744659","Spinal Cord Stimulation for Poststroke Spasticity","Spinal Cord Stimulation for Poststroke Spasticity: a Multicentre, Double-blind, Randomised, Sham-controlled Trial (SCS-PSS)","SCS-PSS","Inclusion Criteria:\n\n1. Aged ≥18 years and \\\u003C75 years, regardless of sex;\n2. Diagnosed with ischemic or hemorrhagic stroke, with unilateral or single-limb motor dysfunction persisting for at least 6 months;\n3. The primary brain lesion and its underlying cause are clinically stable;\n4. Presence of unilateral upper- or lower-limb spasticity, with a Modified Ashworth Scale (MAS) grade of ≥2 in at least two muscle groups of the affected limb;\n5. Post-stroke limb dysfunction has not reached the treatment goal despite previous interventions, such as physical therapy and oral medications, and the participant's condition has shown no recent improvement;\n6. The type and dose of existing rehabilitation therapy and oral antispastic medications must remain unchanged during the study;\n7. Willing and able to complete all study visits and procedures;\n8. Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Any contraindication to spinal cord stimulation surgery;\n2. Uncontrolled refractory epilepsy;\n3. Presence of tonic spasticity, such as decorticate rigidity or decerebrate rigidity;\n4. Poorly controlled severe psychiatric or cognitive impairment, defined as a Beck Depression Inventory-II score \\>25 or a Mini-Mental State Examination score \\\u003C24;\n5. Active systemic infection;\n6. Presence of an implanted neurostimulator or drug delivery system;\n7. Botulinum toxin treatment within 4 months before enrollment;\n8. Plans to initiate any new treatment during the study that may affect limb movement, including chemical denervation therapies (such as botulinum toxin), oral antispastic medications, surgical procedures (such as peripheral neurotomy or contralateral C7 nerve transfer), or other physical therapy interventions;\n9. Pregnancy, breastfeeding, or planned pregnancy during the study;\n10. The participant or family is unable or unwilling to participate in long-term SCS treatment management;\n11. Participation in another clinical study within 4 weeks before signing informed consent;\n12. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":21,"type":22},92,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether spinal cord stimulation (SCS) is effective in treating post-stroke spasticity in adults. It will also evaluate the safety of the implanted SCS system. The main questions it aims to answer are:\n\n1. Does active SCS reduce limb spasticity compared with sham stimulation?\n2. What device-related problems do participants experience during the study?\n\nAll participants receive the same implantation and programming procedures,but no therapeutic stimulation(0 mA) for sham SCS group duringthe first 6 weeks after randomization.\n\nParticipants will:\n\n1. Have an SCS system surgically implanted\n2. Be randomly assigned to receive active SCS or sham SCS for 6 weeks\n3. After completion of the 6-week randomized comparison period, active stimulation will be initiated for all participants.\n4. Attend a post-operative visit within 3 to 7 days after surgery for device activation or sham activation, programming, safety checks, and study assessments\n5. Attend follow-up visits for study assessments at approximately 6, 12, 24 weeks, 1 year and 2 years after randomization\n6. Complete assessments of muscle spasticity, joint range of motion, motor function, walking ability, daily functioning, pain, and quality of life\n7. Report any medical problems or device-related problems during the study",[28],"Spasticity Post Stroke",[30,31,32,33,34],"Spinal Cord Stimulation","Spasticity","Limb function","Stroke","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-29",{"date":38,"type":39},"2026-08-04","ACTUAL",{"date":41,"type":22},"2026-08-06",{"date":43,"type":22},"2027-05-31",{"name":45,"class":46},"Beijing Pins Medical Co., Ltd","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100647719","implantable-hypoglossal-nerve-stimulation-for-obstructive-sleep-apnea-100647719","NCT07711678","Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea","A Pilot Study of Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea","Inclusion Criteria\n\n1. Age 18 years or older, regardless of sex.\n2. Moderate-to-severe obstructive sleep apnea confirmed by polysomnography, with an apnea-hypopnea index of 15 to 100 events per hour.\n3. Prior failure of, intolerance to, or unwillingness to continue positive airway pressure therapy.\n4. Body mass index ≤40 kg\u002Fm².\n5. Able to communicate with the investigator, understand the study requirements, and provide written informed consent.\n6. Willing and able to comply with study procedures and complete postoperative follow-up visits.\n\nExclusion Criteria\n\n1. Central and mixed apnea and hypopnea events account for more than 25% of the total apnea-hypopnea index.\n2. Presence of obvious fixed upper airway obstruction or obstructive upper airway lesions, including but not limited to tumors or masses, polyps, scar stenosis, or severe nasal septal deviation involving the nasal cavity, nasopharynx, oropharynx, hypopharynx, or larynx, which, in the investigator's judgment, may affect device implantation, treatment effect, or evaluation of the primary effectiveness endpoint.\n3. Abnormal hypoglossal nerve function; neurological or neuromuscular disease that may affect upper airway neuromuscular control or tongue movement; or clinically significant dysphagia.\n4. Severe cardiopulmonary disease, including but not limited to chronic obstructive pulmonary disease, severe asthma, chronic respiratory failure, myocardial infarction, or severe arrhythmia.\n5. Any disease or condition that precludes general anesthesia or may interfere with implantation of the hypoglossal nerve stimulation system.\n6. Pregnant or lactating women, or women planning pregnancy during the study period.\n7. Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.\n8. Participation in another clinical trial within 4 weeks before signing informed consent.\n9. Presence of an implanted active medical device that may interact with the investigational hypoglossal nerve stimulation system, affect treatment effectiveness, or compromise participant safety.\n10. Unable or unwilling to discontinue other obstructive sleep apnea-related treatments during the study, except for the investigational hypoglossal nerve stimulation system manufactured by Beijing PINS Medical Co., Ltd.",{"count":56,"type":22},10,[25],"The objective of this study is to evaluate the safety and preliminary effectiveness of an implantable hypoglossal nerve stimulation system for moderate-to-severe obstructive sleep apnea (OSA).",[60,61,62,63],"Obstructive Sleep Apnea (OSA)","Syndrome, Obstructive Sleep Apnea","Respiration Disorders","Sleep Apnea Syndrome, Obstructive",[65],"Hypoglossal nerve stimulation","2026-07-14",{"date":68,"type":39},"2026-07-17",{"date":70,"type":22},"2026-07-15",{"date":72,"type":22},"2027-02-28",{"name":45,"class":46},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100641284","adaptive-dbs-for-pd-100641284","NCT07635823","Adaptive DBS for PD","Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial","SMART-DBS","Inclusion Criteria:\n\n* idiopathic Parkinson's disease\n* Hoehn \\& Yahr (HY) stage 2.5-4 during medication \"OFF\"\n* Subjects must meet one of the following:\n\n  1. Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;\n  2. Previous bilateral STN\u002FGPi DBS recipients with only one IPG who:\n* Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,\n* Consent to device replacement with G1010R DBS system.\n* Willing and physically\u002Fmentally able to complete all study visits and procedures\n* Capable of comprehending and providing written informed consent\n\nExclusion Criteria:\n\n* Presence of contraindications to deep brain stimulation (DBS) surgery.\n* Beck Depression Inventory-II (BDI-II) score \\> 25\n* Mini-Mental State Examination (MMSE) score \\\u003C 24 (adjusted for educational level)\n* Significant comorbidities that may interfere with DBS therapy per investigator assessment.\n* Pre-existing active non-DBS medical implants or metallic cranial implants\n* Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period\n* History of ablative neurosurgery or stem cell therapy for Parkinson's disease\n* Inability to complete ≥3 consecutive days of comprehensive motor\u002Fsleep diaries\n* Inability to maintain prescribed medication regimens or comply with protocol requirements\n* Current pregnancy, lactation, or planned pregnancy during the study period\n* Other conditions deemed by investigators to compromise study suitability\n* Participation in other interventional clinical trials within 4 weeks prior to consent",{"count":83,"type":22},60,[25],"The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.",[87],"Parkinson Disease(PD)",[89,90,91,92,93],"Parkinson Disease","Deep brain stimulation","Adaptive DBS","Close-loop DBS","Dyskinesia","RECRUITING","2026-06-17",{"date":97,"type":39},"2026-06-22",{"date":99,"type":39},"2026-05-16",{"date":101,"type":22},"2027-09-30",{"name":45,"class":46},9,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100571624","a-trial-of-rehabilitation-paired-with-vns-for-motor-function-in-patients-with-stroke-repair-study-100571624","NCT06722677","A Trial of Rehabilitation Paired with VNS for Motor Function in Patients with Stroke (Repair Study)","A Multi-Center, Triple-Blind, Randomized, Sham-Controlled Trial Assessing the Efficacy and Safety of Rehabilitation Paired with Vagus Nerve Stimulation for Upper Extremity Motor Function in Patients with Ischemic Stroke (Repair Study)","Inclusion Criteria:\n\n1. Age ≥22 years and \\\u003C80 years, all gender is acceptable.\n2. History of unilateral supratentorial ischemic stroke ≥ 9 months but \\\u003C 10 years.\n3. Upper Extremity motor section of the Fugl-Meyer Assessment score ≥20 and ≤50.\n4. Right- or left-sided weakness of upper extremity.\n5. Ability to communicate, understand, and give appropriate consent. Subjects can follow trial commands.\n6. Subjects have good compliance and can complete the visits after surgery.\n\nExclusion Criteria:\n\n1. History of hemorrhagic stroke.\n2. Presence of ongoing dysphagia or aspiration difficulties.\n3. Prior injury to vagus nerve, either bilateral or unilateral.\n4. Subject receiving medication that may significantly interfere with actions of VNS on neurotransmitter systems at study entry, clinic rehabilitation follow-up timepoint, or home rehabilitation follow-up timepoint, such as centrally acting cholinoceptor blockers, centrally acting adrenoceptor blockers, norepinephrine re-uptake inhibitors, etc.\n5. Botox injections within 4 weeks prior to enrollment through the unmasking follow-up timepoint (Visit 6).\n6. Severe spasticity of the upper extremity (Modified Ashworth ≥ 3).\n7. Significant sensory loss of the upper extremity (Upper Extremity sensory section of the Fugl-Meyer Assessment score \\\u003C 6).\n8. Severe depression (Beck Depression Scale \\> 29).\n9. Current requirement, or likely future requirement, of diathermy.\n10. Current use of any other stimulation device, such as a pacemaker or other neurostimulator.\n11. Pregnancy or plans to become pregnant or to breastfeed during the study period.\n12. Participated in any other clinical trials within the preceding 3 months.\n13. Not considered to be applicable by the investigator.","22 Years","80 Years",{"count":114,"type":22},99,[25],"The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) paired with rehabilitation for enhancing upper extremity motor function after ischemic stroke.\n\nResearchers will compare the outcomes of active VNS paired with rehabilitation against sham VNS (the actual intensity is 0 mA) also paired with rehabilitation, in order to assess improvements in arm motor function post-stroke.\n\nParticipants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.",[118,119],"Ischemic Stroke","Upper Extremity Paresis",[33,118,121,119,122,123,34,124],"Paresis","Vagus Nerve Stimulation","Neuromodulation","Rehabilitation","2024-12-09",{"date":127,"type":39},"2024-12-10",{"date":129,"type":39},"2024-11-19",{"date":131,"type":22},"2025-11",{"name":45,"class":46},16,""]