[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07145489":3,"trial-entities:NCT07145489":93,"trial-summary:NCT07145489":97},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":36,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":64,"locations":67,"central_contacts":85,"overall_officials":89,"references":91,"see_also_links":92},"NCT07145489","2025P000606","Infrared Photobiomodulation in Humans With Epilepsy","An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy","RECRUITING","2027-09-25","2026-02","2026-02-04","2025-11-25","Beth Israel Deaconess Medical Center","OTHER",false,"Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very challenging to stop seizures in this condition, and the treatment options are limited. This study aims to investigate a new treatment that involves using infra-red light. In animals, this treatment has shown promise as a possible way to reduce seizures, but it has not been tested in humans for this. The investigators are interested to know if it can reduce seizures, and how comfortable it is to be treated with this therapy.","Epilepsy affects 12 out of every 1000 people in the United States (1.2%). Of those, roughly 40% have drug-resistant epilepsy, meaning seizures do not stop despite good doses given with two different anti-seizure medications. Patients in this situation have several options (1) try additional medications (2) consider surgery to remove the part of the brain causing seizures, if possible (3) consider neuromodulation devices that change the brain activity using electricity in the brain (also a surgery) (4) try special diets such as the ketogenic diet which changes the fuel used by the brain by only eating certain foods. Despite these options, a large number of patients continue to have seizures. There is a great need for new treatments for drug resistant epilepsy.\n\nThe main purpose of this study is to determine if a new treatment is safe and well tolerated. Everyone in this study will receive the Red Light Therapy Hat which is investigational and is not approved by the FDA. The investigators do not know all the ways that this study treatment may affect people. This study is intended to hopefully help the participants, and the investigators hope the information from this study will help us develop a better treatment for drug resistant epilepsy in the future.\n\nThis particular investigational technology has been approved by the FDA for use in other diseases or conditions, but the investigators do not yet know if it is useful or safe as a treatment for drug resistant epilepsy.",[19],"Drug Resistant Epilepsy",[21,22,23],"epilepsy","photobiomodulation","seizure","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},13,"ESTIMATED",[32],{"type":33,"name":22,"description":34,"armGroupLabels":35},"DEVICE","a hat with infrared lights will be worn for 30 minutes daily for 6 months",[22],[37,41],{"measure":38,"description":39,"timeFrame":40},"seizure rate reduction","fraction of seizures reduced by therapy assessed by individual baseline rate","6 months",{"measure":42,"description":43,"timeFrame":40},"tolerability of daily photobiomodulation","Do participants find it reasonable to use the therapy daily or do they request exiting from the study? Do participants report significant side effects as reported by weekly check-ins that make the therapy uncomfortable or intolerable?",[45],{"measure":46,"description":47,"timeFrame":40},"seizure duration","fraction of seizure duration reduction assessed by baseline seizure durations","ALL","18 Years",null,{"inclusion":52,"exclusion":57,"raw_text":63},[53,54,55,56],"Drug resistant epilepsy","Age 18 or older","Average seizure rate of at least 2 seizures per month","Accurate seizure diary with at least 3 months recorded",[58,59,60,61,62],"Implanted intracranial neurostimulation device (DBS or RNS)","Intracranial shunt","Skin photosensitivity","Cancer on scalp","Taking any medication that can cause photosensitivity","Inclusion Criteria:\n\n* Drug resistant epilepsy\n* Age 18 or older\n* Average seizure rate of at least 2 seizures per month\n* Accurate seizure diary with at least 3 months recorded\n\nExclusion Criteria:\n\n* Implanted intracranial neurostimulation device (DBS or RNS)\n* Intracranial shunt\n* Skin photosensitivity\n* Cancer on scalp\n* Taking any medication that can cause photosensitivity",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":82},"BIDMC","Boston","Massachusetts","02215","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Daniel Goldenholz, MD PhD","CONTACT","617-632-8930","daniel.goldenholz@bidmc.harvard.edu",{"name":76,"role":81},"PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},42.35843,-71.05977,[86,88],{"name":87,"role":77,"phone":78,"email":79},"Daniel Goldenholz, MD, PhD",{"name":76,"role":77,"phone":78,"email":79},[90],{"name":76,"affiliation":13,"role":81},[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Seizure Disorder",[],{"nct_id":4,"found":98,"summary":99,"prompt_version":109},true,{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study with a planned enrollment of 13 participants. All participants will receive the photobiomodulation device.","completed","Infrared Photobiomodulation for Drug-Resistant Epilepsy","This study is exploring a new treatment for drug-resistant epilepsy, a condition where seizures continue despite medication. The treatment involves wearing a hat with infrared lights (photobiomodulation) for 30 minutes daily over six months. Researchers want to see if this treatment can reduce your seizure rate and how comfortable it is to use. You might be able to join if you are 18 or older, have drug-resistant epilepsy with at least two seizures per month, and have kept an accurate seizure diary for at least three months. This treatment has shown promise in animal studies, but this is the first time it's being tested in humans. The study is currently unclear on its recruitment status.","Your seizure rate reduction and tolerability will be measured at six months.",115,"You would wear a hat with infrared lights for 30 minutes daily for six months.","Not stated in the trial record.",[22],"v2"]