[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419702":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":19,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":19,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":19,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":56,"overallStatus":70,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":19},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RNS System Implantation","EXPERIMENTAL","This is a device feasibility study, therefore participants will only be enrolled into the investigational arm and will receive the RNS System Implantation.",[13],"Device: RNS System Implantation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Following resection consistent with SoC, if there is evidence of residual tumor which cannot be resected due to invasion of hand-M1 but which is small enough to be covered by two four-electrode strips, these strips will be placed on the functional cortex of interest and secured to the dura. The location of the leads will be registered into the navigation software (either Medtronic Stealth or Brainlab). The dura will then be closed as watertight as possible, and the RNS System will be incorporated into the craniotomy on closure Prior to closure, four bone screws will be placed and registered to the intraoperative navigation system as internal fiducials to be retrieved for future procedures.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Max Krucoff, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Sarah Cornell","CONTACT","414-955-0989","scornell@mcw.edu",{"type":23,"investigatorFullName":22,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Assistant Professor of Neurological Surgery","100419702","a-study-using-brain-stimulation-and-behavioral-therapy-to-increase-extent-of-resection-in-low-grade-gliomas-100419702",false,"NCT04745156","A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas","Inducing Functional Plasticity in Glioma-Involved Functional Cortex With Deficit-Inducing Cortical Stimulation and Targeted Behavioral Therapy to Increase Extent of Resection","Inclusion Criteria:\n\n1. Age 18-65 years old\n2. Ability to understand a written informed consent document, and the willingness to sign it\n3. Radiographic evidence of likely low-grade glioma on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.\n4. Karnofsky performance status (KPS) ≥ 75\n5. Normal or near normal motor strength (i.e., at least 3\u002F5 in relevant areas)\n6. Normal or near normal speech (Can consistently name at least 4\u002F5 cards)\n7. No medical contraindication to surgery\n8. Free of other illness that may shorten life expectancy\n\nExclusion Criteria:\n\n1. Presence of other malignancy not in remission\n2. Evidence of bi-hemispheric or widespread tumor involvement\n3. Likely candidate to receive GTR on initial resection\n4. Medically high-risk surgical candidate\n5. History of recent scalp or systemic infection\n6. Presence of other implants or foreign bodies in the head\n7. Inability to receive an MRI for any reason\n8. Inability to receive cortical stimulation for any reason\n9. Coagulation disorders and\u002For use of anti-thrombotic therapies\n10. Platelet count \\\u003C 50\n11. Diathermy procedures\n12. Electroconvulsive Therapy (ECT)\n13. Transcranial Magnetic Stimulation (TMS)\n14. Presence of implanted cardiac device (such as a pacemaker or defibrillator)\n15. Pregnant women","ALL","18 Years","65 Years",{"count":43,"type":44},3,"ESTIMATED","INTERVENTIONAL",[47],"NA","This study uses a cranial implant to deliver cortical stimulation that, when paired with physiotherapy, will remap the brain so that critical brain functions can be protected during brain tumor surgery. This pilot study will provide initial evidence for the safety and feasibility of such a protocol which will lead to future pivotal trials that could radically change eloquent area brain surgery. For patients with otherwise incompletely resectable brain tumors, this could mean a longer life expectancy and a better quality of life.",[50,51,52,53,54,55],"Glioma","Glioma Intracranial","Gliomas Benign","Brain Tumor","Brain Cancer","Motor Cortex; Lesion",[57,58,59,60,61,62,63,64,65,66,67,68,69],"Brain Stimulation","NeuroPace","Cortex Stimulation","Neuroplasticity","Plasticity","Hand Motor Cortex","Primary Motor Cortex","M1","Motor Mapping","Resection","Surgery","Motor Rehabilitation","Prehabilitation","NOT_YET_RECRUITING","2026-01-09",{"date":73,"type":74},"2026-01-12","ACTUAL",{"date":76,"type":44},"2026-08-01",{"date":78,"type":44},"2027-09",{"name":5,"class":6}]