[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657135":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":66,"studyPopulation":66,"armGroups":75,"interventions":88,"overallOfficials":66,"centralContacts":98,"locations":104,"responsibleParty":124,"collaborators":128,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":66,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":66,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":158,"whyStopped":66,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"University of California, San Diego","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Active vs Sham spaced tDCS Efficacy as measured by the Montgomery-Åsberg Depression Rating Scale","To compare the efficacy of active versus sham spaced tDCS in reducing depressive symptom severity in TRD. Symptom severity will be measured using the MADRS score at four weeks post-treatment.","Baseline to 4-weeks post treatment",[14,18,21,24,27,30,34,37,41,44],{"measure":15,"description":16,"timeFrame":17},"Changes in MADRS with active versus sham spaced tDCS during all post treatment visits","Clinical outcomes associated with active versus sham spaced tDCS as measured by MADRS response (≥50% reduction) and remission (score ≤10) rates.","1-week post treatment to 10-week post treatment",{"measure":19,"description":20,"timeFrame":17},"Changes in Hamilton Depression Rating Scale, 17-item version scores","Reduction in HAMD-17 scores at all follow-up timepoints. Score range from 0 to 52.",{"measure":22,"description":23,"timeFrame":17},"Changes in Patient Health Questionnaire-9","Changes in PHQ scores at all follow-up timepoints. With scores ranging from 0-27",{"measure":25,"description":26,"timeFrame":17},"Changes in General Anxiety Disorder-7","Changes in GAD-7 scores at all follow-up timepoints. Score range from 0-21",{"measure":28,"description":29,"timeFrame":17},"Changes in The Modified Scale for Suicidal Ideation","Changes in the presence and severity of suicidal thoughts at all follow-up timepoints. Scores ranging from 0-54",{"measure":31,"description":32,"timeFrame":33},"Feasibility (Recruitment)","Recruitment rate will be measured as the number of patients enrolled by the conclusion of the study, reported as a whole number.","Baseline clinical assessment to 10 weeks post treatment.",{"measure":35,"description":36,"timeFrame":33},"Feasibility (Retention)","Retention rate will be measured as the percentage of enrolled patients who complete all study visits, reported as a percentage.",{"measure":38,"description":39,"timeFrame":40},"Feasibility (Adherence)","The proportion of completed sessions relative to the total prescribed sessions, expressed as a percentage.","Baseline clinical assessment to 10 weeks post treatment",{"measure":42,"description":43,"timeFrame":40},"Safety of at-home spaced tDCS","Safety will be measured by the number of serious adverse events (SAEs)",{"measure":45,"description":46,"timeFrame":33},"Tolerability to spaced tDCS","Tolerability will be measured by the number of adverse events (AEs).",[48,51,54,57,60],{"measure":49,"description":50,"timeFrame":12},"Biomarker Discovery: Short-Interval Intracortical Inhibition (SICI) and Long-Interval Intracortical Inhibition (LICI) via TMS-EMG","TMS-EMG will be used to evaluate changes in SICI and LICI.",{"measure":52,"description":53,"timeFrame":12},"Biomarker Discovery: Intracortical Facilitation (ICF) via TMS-EMG","TMS-EMG will be used to evaluate changes in intracortical facilitation",{"measure":55,"description":56,"timeFrame":12},"Biomarker Discovery: Cortical Silent Period (CSP) via Transcranial Magnetic Stimulation-Electromyography (TMS-EMG)","TMS-EMG will be used to assess changes in the cortical silent period (CSP). Unit of Measurement: Duration (milliseconds).",{"measure":58,"description":59,"timeFrame":12},"TMS-Evoked Potential (TEP) Component Amplitudes via TMS-EEG","TMS-EEG will be used to evaluate changes in TMS-evoked potential (TEP) component amplitudes.\n\nUnit of Measurement: Voltage (µV).",{"measure":61,"description":62,"timeFrame":12},"Resting-State Electroencephalography (rsEEG)","rsEEG will be used to analyze changes in brain activity patterns at rest. Unit of Measurement: Frequency (Hz)",{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":67,"observationalModel":66,"timePerspective":66,"maskingInfo":68},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":69,"maskingDescription":70,"whoMasked":71},"TRIPLE","tDCS operators, study raters, and clinicians remain blinded throughout the trial.",[72,73,74],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[76,82],{"label":77,"type":78,"description":79,"interventionNames":80},"Active spaced-tDCS","ACTIVE_COMPARATOR","Active tDCS applies low-intensity electrical current to the scalp to modulate cortical excitability through subthreshold shifts in neuronal membrane potentials, influencing synaptic plasticity",[81],"Device: Spaced Transcranial Direct Current Stimulation (tDCS)",{"label":83,"type":84,"description":85,"interventionNames":86},"Sham spaced-tDCS","SHAM_COMPARATOR","Sham tDCS is a placebo control that simulates the physical sensations of tDCS but does not deliver any actual, prolonged electrical current to the brain.",[87],"Device: Sham Spaced tDCS",[89,94],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":66},"DEVICE","Spaced Transcranial Direct Current Stimulation (tDCS)","Spaced-tDCS will be self-administered at home under the supervision of a trained clinical research coordinator using the Soterix Medical mini-CT device with remote monitoring via a secure videoconferencing platform (e.g., Microsoft Teams).",[77],{"type":90,"name":95,"description":96,"armGroupLabels":97,"otherNames":66},"Sham Spaced tDCS","Soterix Medical mini-CT device sham protocol that match real stimulation parameters will be used.",[83],[99],{"name":100,"role":101,"phone":102,"phoneExt":66,"email":103},"Interventional Psychiatry","CONTACT","858-657-6149","iptrials@health.ucsd.edu",[105],{"facility":106,"status":66,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"UCSD Interventional Psychiatry","San Diego","California","92127","United States","US",{"type":113,"coordinates":114},"Point",[115,116],-117.16472,32.71571,{"lat":116,"lon":115},[119,121],{"name":120,"role":101,"phone":102,"phoneExt":66,"email":103},"Edith Jimenez",{"name":122,"role":101,"phone":123,"phoneExt":66,"email":66},"UCSD Interventional Psychiatry Clinic","858-207-0938",{"type":125,"investigatorFullName":126,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"PRINCIPAL_INVESTIGATOR","Jean-Philippe Miron","MD, PhD",[129],{"name":130,"class":131},"National Institute of Mental Health (NIMH)","NIH","100657135","home-based-randomized-trial-of-spaced-transcranial-direct-current-stimulation-for-treatment-resistant-depression-100657135",false,"NCT07834762","Home-Based Randomized Trial of Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression","Spaced Transcranial Direct Current Stimulation for Treatment-Resistant Depression: A Home-Based Randomized Sham-Controlled Trial and Mechanistic Exploration","Inclusion Criteria:\n\n* People between the ages of 18 and 70 at the time of screening.\n* Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires \u002F follow instructions during interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.\n* Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).\n* Medical records confirming a history of at least moderate treatment-resistance as defined on Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of \\> 2 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.\n* MADRS score of ≥20 at screening.\n* Existing relationship with mental health provider and access to ongoing psychiatric care before and after completion of the study.\n* Must be on a stable antidepressant therapeutic regimen for at least 4 weeks prior to study enrollment and agree to continue this regimen throughout the study period. Participants who are not currently on antidepressant treatment are eligible, provided that no discontinuation occurred within the 4 weeks preceding study enrollment.\n* For persons of child-bearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.\n* Agreement to adhere to Lifestyle Considerations (i.e. must continue with any existing treatments) throughout study duration.\n* For persons of childbearing potential: must take a pregnancy test prior to initiating treatment, with results confirmed as negative by study staff\n* Participants will need to have a stable internet connection and a device compatible with UCSD Microsoft Teams or UCSD Zoom to facilitate remote communication and engagement in study activities.\n\nExclusion Criteria:\n\n* Pregnancy this includes breastfeeding or trying to becoming pregnant.\n* History of psychotic or bipolar disorder or depression with psychotic features.\n* Significant borderline personality disorder.\n* Significant comorbid obsessive-compulsive or post-traumatic stress disorder.\n* Previously diagnosed Intellectual Disability or Autism Spectrum Disorder.\n* Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.\n* Clinically significant suicidality.\n* Any history of tDCS.\n* Any history of ECT.\n* History of TMS (greater than 15 sessions) without a clinically meaningful response.\n* History of ketamine (greater than 4 sessions) without a clinically meaningful response.\n* History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent symptoms.\n* Untreated or insufficiently treated endocrine disorder.\n* Contraindication to receiving tDCS (e.g., ferromagnetic implant, history of seizure, known brain lesion).\n* Treatment with an investigational drug or other intervention within the study period.\n* Unstable symptoms between screening and baseline as defined by a ≥ 30% change in MADRS score.\n* Require a benzodiazepine with a dose \\> lorazepam 2 mg\u002Fday\n* Has started a new psychotherapeutic process in the past 3 months from screening.\n* Use of potentially irritant topical treatments (ex: retinoids, alpha hydroxy acids).","ALL","18 Years","70 Years",{"count":143,"type":144},74,"ESTIMATED","INTERVENTIONAL",[147],"NA","This study aims to evaluate the clinical efficacy and neurophysiological mechanisms of home-based spaced tDCS in TRD through a randomized, double-blind, sham-controlled trial conducted under remote supervision. Specifically, this trial will: (1) compare the efficacy of active versus sham spaced tDCS on depressive symptom severity in individuals with TRD and (2) characterize neurophysiological changes associated with spaced tDCS using TMS-EEG, TMS-EMG and resting state EEG.",[150,151],"Treatment Resistant Depression (TRD)","Major Depressive Disorder (MDD)",[153,154,155,156,157],"tDCS","Treatment Resistant Depression","Major Depressive Disorder","MDD","transcranial direct current stimulation","NOT_YET_RECRUITING","2026-09-16",{"date":161,"type":162},"2026-09-22","ACTUAL",{"date":164,"type":144},"2026-10-15",{"date":166,"type":144},"2031-10-15",{"name":5,"class":6},1]