[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530661":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":23,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":39,"whyStopped":23,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"rTMS 5 Hz group","EXPERIMENTAL","Two-session\u002Fday 5-Hz rTMS will be administered by two week (weekdays) with a 30-minutes inter-session interval. A total of 20 sessions will be administered. Then two sessions per week along 12 weeks will be administered as maintenance phase. Parameters are considered as follow: 10 s. train, 10 s. inter-train interval, 2500 pulses per session at 100% of motor threshold (MT).",[13],"Device: rTMS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham group","SHAM_COMPARATOR","Two-session\u002Fday sham 5-Hz rTMS will be administered by two week (weekdays) with a 30-minutes inter-session interval. A total of 20 sessions will be administered. Then two sessions per week along 12 weeks will be administered as maintenance phase. Parameters are considered as follow: 10 s. train, 10 s. inter-train interval, 2500 pulses per session at 100% of motor threshold (MT).",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"no rTMS control group","NO_INTERVENTION","The patients on this group will receive any rTMS intervention. The purpose of this gruop is to compare all clinical, cognitive variables and BDNF levels under conditions of no cocaine\u002Fcrack consumption, i.e., controlled environments, without rTMS.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DEVICE","rTMS","Repetitive TMS will be administered by a MagPro R30 stimulator and an active\u002Fplacebo MCF-B70 A\u002FP coil. All participants will use two surface electrodes to simulate rTMS skin sensations near to stimulation site. rTMS\u002Fsham conditions will be double-blinded by a USB stick. The USB contains the information about rTMS\u002Fsham condition and this is not available to the stimulator operator. Parameters of rTMS were previously described.",[15,9],[31],{"name":32,"role":33,"phone":34,"phoneExt":23,"email":35},"Erik D. Morelos-Santana, Ph D. Candidate","CONTACT","5255416053503","emorelos@imp.edu.mx",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Instituto Nacional de Psiquiatría Ramón de la Fuente M.","RECRUITING","Mexico City","Tlalpan","14370","Mexico","MX",{"type":46,"coordinates":47},"Point",[48,49],-99.12766,19.42847,{"lat":49,"lon":48},[52],{"name":32,"role":33,"phone":53,"phoneExt":23,"email":35},"525541605303",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Erik D. Morelos-Santana","Principal Investigator",[59],{"name":60,"class":6},"National Council of Science and Technology, Mexico","100530661","effect-of-hf-rtms-on-serum-bdnf-in-cocaine-use-disorder-100530661",false,"NCT06189690","Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder","Effects of 5-Hz Repetitive Transcranial Magnetic Stimulation on Serum Brain Derived Neurotrophic Factor and Clinical Variables in Cocaine Use Disorder","Inclusion Criteria:\n\n1. Current cocaine use disorder according to the Diagnostic and statistical manual of mental disorders (DSM 5).\n2. Cocaine crack or powder use for at least 12 months with a frequency of 3 times or more per week, with abstinence periods shorter than 1 year for the last year.\n3. Primary school completed.\n\nExclusion Criteria:\n\n1. Personal or first degree family history of any neurological disorder including, but not limited to, organic brain syndrome, epilepsy, brain injuries, multiple sclerosis, conditions that increase intracranial pressure.\n2. Personal history of brain surgery or traumatic brain injury.\n3. Comorbilities that could represent a risk of neuroinfection or increased convulsive threshoid.\n4. Other than alcohol, tobacco or marijuana substance use disorder.\n5. If the patient does not meet the safety criteria for rTMS.\n6. Current use of any medication that might provoque seizures or any anticonvulsant drugs.\n7. Personal history of schizophrenia, mania\u002Fhypomania or OCD.\n8. Personal history of myocardial infarction, angina, congestive heart failure, cerebrovascular events, transient ischemic attack or any other heart condition currently undergoing medical treatment.\n9. Personal history of seizures or detection of paroxysmal EEG activity.","ALL","18 Years","50 Years",{"count":72,"type":73},102,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study aims to explore the effect of 5-Hz rTMS over the left dorsolateral prefrontal cortex on the BDNF, craving and cognitive function. This study will be longitudinal, with a short-term double-blind placebo-controlled phase consisting of 20 rTMS sessions and a long-term phase, consisting of 2 weekly sessions for 12 weeks. Participants will be clinically assessed pre-treatment (T0), after 20-sessions phase (T1) and after 12-weeks phase (T2) by an interview about psychiatric symptoms. Also, blood will be obtained in the same T0, T1 and T2 to peripheral levels of BDNF determination. Cognitive state will be measured at the same time-points (T0, T1, T2) by paper-pencil and computerized neuropsychological assessment. Researchers will compare active rTMS versus placebo 5 Hz-rTMS on described variables. Additionally, a comparative group (without rTMS intervention) will be included to equivalently measure described variables during periods without cocaine consumption.",[79],"Cocaine Dependence",[81,82,27,83],"Craving","BDNF","DLPFC","2023-12-19",{"date":86,"type":87},"2024-01-03","ACTUAL",{"date":89,"type":87},"2022-01-06",{"date":91,"type":73},"2027-12-01",{"name":5,"class":6},1]