[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06748209":3,"trial-entities:NCT06748209":97,"trial-summary:NCT06748209":101},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":66,"locations":69,"central_contacts":85,"overall_officials":91,"references":95,"see_also_links":96},"NCT06748209","Pro00139739","Establishing Mobile Transcranial Magnetic Stimulation","Portable Transcranial Magnetic Stimulation (TMS) in a Van for Treatment-Resistant Depression","RECRUITING","2028-03-01","2026-05","2026-05-06","2025-05-10","Medical University of South Carolina","OTHER",false,"In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all affiliated with MUSC and within 2-hours driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable feasibility, safety, and efficacy lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option, both in our state and across the US.","In this pilot study, investigators propose to design and create a portable TMS unit, in a van, and then test out delivering TMS in three different locations in South Carolina, all within 90 minutes driving from Charleston, SC. This study would test out this new delivery mode, and provide valuable lessons for later refinement and potential widespread adoption of mobile TMS as a treatment option. This would open up access to TMS for millions of patients with treatment resistant depression who cannot be treated in the current model. After this pilot feasibility and efficacy study, future research would use mobile TMS units for siting at residential care facilities, or remote hospitals and clinics.\n\nInvestigators aim to determine whether it is possible to assemble and build a functioning mobile TMS unit. After assembling the van, investigators will then recruit up to 30 treatment-resistant depression patients who live near one of three satellite MUSC clinics. These clinics are all within a 2 hour drive from the MUSC Charleston campus. Investigators will treat these patients, open label, with FDA approved accelerated TMS (6 sessions each day, over 2 hours, for 5 days, spread over one or two weeks). Investigators will measure TMS effectiveness using standard depression rating scales. Importantly, investigators will also collect the costs of performing the TMS which will inform whether MUSC or other health delivery systems might adopt this TMS method.",[19],"Treatment Resistant Major Depression",[21,22],"Anxiety","Depression","INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},30,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Left prefrontal Transcranial Magnetic Stimulation (TMS)","FDA cleared TMS",[36],"Open label Clinical TMS for Depression",{"type":32,"name":38,"description":39,"armGroupLabels":40},"FDA cleared TMS for treating depression","This is FDA approved TMS",[36],[42,46],{"measure":43,"description":44,"timeFrame":45},"Percent of depression responders","Number of patients with \\>50% improvement in Phq-9 scores before and then after 5 days of treatment","From baseline to 1 week immediately after treatment week",{"measure":47,"description":48,"timeFrame":45},"Improvement in Depression Symptoms","Change in Phq-9 ratings from baseline to end of treatment",[],"ALL","22 Years","80 Years",{"inclusion":54,"exclusion":60,"raw_text":65},[55,56,57,58,59],"Adult (22-80 years old)","Have treatment-resistant depression as defined by the e-Mini, and the antidepressant treatment history form (ATHF short).","Be able to read and communicate in English.","Able to provide their own consent.","Access to a computer with videoconferencing ability for initial consent and telescreen.",[61,62,63,64],"Patients with unstable medical conditions that might make TMS unsafe. This includes current poorly controlled seizures.","Ferromagnetic metal in the head.","Pregnant.","Currently active substance abuse except tobacco.","Inclusion Criteria:\n\n* Adult (22-80 years old)\n* Have treatment-resistant depression as defined by the e-Mini, and the antidepressant treatment history form (ATHF short).\n* Be able to read and communicate in English.\n* Able to provide their own consent.\n* Access to a computer with videoconferencing ability for initial consent and telescreen.\n\nExclusion Criteria:\n\n* Patients with unstable medical conditions that might make TMS unsafe. This includes current poorly controlled seizures.\n* Ferromagnetic metal in the head.\n* Pregnant.\n* Currently active substance abuse except tobacco.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Medical Univerity of South Carolina","Charleston","South Carolina","29425","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Mark S. George, MD","CONTACT","8438765142","GEORGEM@MUSC.EDU",{"lat":83,"lon":84},32.77632,-79.93275,[86,88],{"name":87,"role":79,"phone":80,"email":81},"Mark S George, MD",{"name":89,"role":79,"email":90},"Alexandra Herron, BA","herronal@musc.edu",[92],{"name":93,"affiliation":13,"role":94},"Mark George, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[21,22,99],"Unipolar Depression",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is a pilot study with 30 participants, testing a new way to deliver FDA-approved TMS in a mobile unit. It is an open-label study, meaning both participants and researchers will know what treatment is being given.","completed","Mobile Transcranial Magnetic Stimulation for Treatment-Resistant Depression","This study is testing a new way to deliver Transcranial Magnetic Stimulation (TMS) for people with depression that hasn't improved with other treatments (treatment-resistant major depression). TMS uses magnetic fields to stimulate nerve cells in the brain. Researchers are building a portable TMS unit in a van and will use it to treat up to 30 participants in three locations in South Carolina. The goal is to see if this mobile approach is practical, safe, and effective. To join, you must be an adult between 22 and 80 years old, have treatment-resistant depression, speak English, and be able to provide consent. The study will measure how many people's depression improves and how much their symptoms lessen after treatment. The study's current status is unclear.","Researchers will measure improvement in depression symptoms and the percentage of responders from the start of the study to one week immediately after the treatment week.",124,"Participants will receive 6 TMS sessions each day, over 2 hours, for 5 days, spread over one or two weeks. You will also need access to a computer for initial consent and a telescreen.","Not stated in the trial record.",[],"v2"]