[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524528":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":56,"collaborators":36,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":36,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":36,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":40,"whyStopped":36,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neurofeedback","EXPERIMENTAL","Half of the participants will be blindly assigned to receive 12 sessions of LIP-tES intervention over 6 weeks. A subset of these participants will also complete a resting-state MRI scan during the initial session (prior to LIP-tES intervention) and after their final LIP-tES intervention.",[13],"Device: Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Treatment","SHAM_COMPARATOR","Half of the participants will be blindly assigned to receive 12 sessions of a sham intervention that will mirror all aspects of the LIP-tES intervention except that no neurofeedback pulses will be delivered. A subset of these participants will also complete a resting-state MRI scan at the beginning of the initial session and at the end of the 12th session.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Micro Current Neurofeedback Device using Low-Frequency Pulse-Based Transcranial Electrical Stimulation","The EEG interface device is a J\\&J Engineering 1-330 C2 box. The software used to determine LIP-tES feedback patterns was developed by Neurogen High Performance Neurofeedback. The EEG sampling frequency is 256 Hz on each of 2 EEG acquisition channels. The feedback LIP-tES is delivered via the 4 EEG leads (A+,A-,B+,B-), with respect to the Common Neck Reference. During each session, 2 electrodes (A- and B-) are attached to the participant's left and right mastoids, while the remaining two electrodes (A+ and B+) are moved to various locations on the scale to record EEG signals. All four (A+,A-,B+,B-) electrodes are involved in applying weak electrical pulses back to the brain (feedback process). The brief feedback pulse (\\~100mV) is adaptive and determined based on the offset of the frequency spectrum recorded across the left and right hemisphere (A vs. B) electrodes in the time window immediately prior to stimulation.",[9,15],[26],"LIP-tES intervention",[28],{"name":29,"affiliation":30,"role":31},"Francesca C Fortenbaugh, PhD","VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","(857) 364-4362",null,"Francesca.Fortenbaugh@va.gov",[39],{"facility":30,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Boston","Massachusetts","02130-4817","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,55],{"name":29,"role":34,"phone":54,"phoneExt":36,"email":37},"857-364-4362",{"name":29,"role":31,"phone":36,"phoneExt":36,"email":36},{"type":57,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100524528","pilot-study-of-neurofeedback-for-photosensitivity-in-mild-traumatic-brain-injury-100524528",false,"NCT06109909","Pilot Study of Neurofeedback for Photosensitivity in Mild Traumatic Brain Injury","A Novel Neurofeedback Intervention for Photosensitivity in Mild Traumatic Brain Injury","Inclusion Criteria:\n\n* Ages 18-65\n* Documented history of mTBI at least 6 months prior to initial study visit\n* Documented symptoms of photosensitivity\n* Eye exam within the last 12 months documenting best-corrected acuity of 20\u002F20 or better, normal pupillary function, color vision, no abnormalities on OCT scan, and normal Humphrey Visual Field test\n\nExclusion Criteria:\n\n* History of strabismus or amblyopia\n* Significant ocular media opacity that could reduce the amount of light entering the pupil in one or both eyes\n* Previous or current history of retinal or optic nerve pathology in one or both eyes\n* History of stroke and\u002For visual neglect\n* History of neurodegenerative disease (e.g., Parkinson's, multiple sclerosis)\n* History of epilepsy or seizures\n* History of motor tics\n* Current use of medications or substances that may severely affect pupillary response and\u002For increase photosensitivity\n* Individuals with impaired decision-making capacity\n* Illiterate or no English language proficiency","ALL","18 Years","65 Years",{"count":69,"type":70},36,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this study is to complete a pilot study testing the feasibility and acceptability of low-intensity pulse-based transcranial stimulation (LIP-tES) neurofeedback intervention for reducing photosensitivity symptoms in Veterans with a history of mild traumatic brain injury (mTBI). The study will also complete resting-state MRI scans to assess neurophysiological markers of photosensitivity and changes associated with LIP-tES intervention.",[76,77],"Mild Traumatic Brain Injury","Photophobia",[79,80],"photophobia","mild traumatic brain injury","2025-12-08",{"date":83,"type":84},"2025-12-16","ACTUAL",{"date":86,"type":84},"2024-01-01",{"date":88,"type":70},"2026-11-30",{"name":5,"class":6},1]