[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551989":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":45,"centralContacts":50,"locations":56,"responsibleParty":71,"collaborators":35,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":35,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":35,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":58,"whyStopped":35,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"1. rTMS + CS","ACTIVE_COMPARATOR","Repetitive Transcranial Magnetic Stimulation (rTMS) + Cognitive Stimulation (CS)",[13],"Device: 1. rTMS + CS",{"label":15,"type":16,"description":17,"interventionNames":18},"2. rTMS Sham + CS","SHAM_COMPARATOR","Repetitive Transcranial Magnetic Stimulation Sham (rTMS Sham) + Cognitive Stimulation (CS)",[19],"Device: 2. rTMS Sham + CS",{"label":21,"type":10,"description":22,"interventionNames":23},"3. tDCS + CS","Transcranial Direct Current Stimulation (tDCS) + Cognitive Stimulation (CS)",[24],"Device: 3. tDCS + CS",{"label":26,"type":16,"description":27,"interventionNames":28},"4. tDCS Sham + CS","Transcranial Direct Current Stimulation Sham (tDCS Sham) + Cognitive Stimulation (CS)",[29],"Device: 4. tDCS Sham + CS",[31,36,39,42],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","In the first phase each participant will receive 15 sessions of rTMS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of rTMS and 1 session of CS per week for 12 weeks. Each session will consist of 10 trains of 10 stimuli, at a 5-Hz frequency and a stimulation intensity of 120% of the resting motor threshold.\n\nrTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active\u002Fplacebo 8-shape coil model MCF-B70.\n\nTwo surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The rTMS condition will be double-blinded through the use of a USB stick.\n\nCognitive stimulation will be a Mexican adaptation of the \"Memory Training and Cognitive Stimulation for Mild Cognitive Impairment\" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.\n\nIn total, each participant will receive 27 sessions of rTMS and 21 sessions of CS.",[9],null,{"type":32,"name":15,"description":37,"armGroupLabels":38,"otherNames":35},"In the first phase each participant will receive 15 sessions of rTMS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham rTMS and 1 session of CS per week for 12 weeks.\n\nIn total, each participant will receive 27 sessions of Sham rTMS and 21 sessions of CS.\n\nrTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active\u002Fplacebo 8-shape coil model MCF-B70.\n\nTwo surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The sham condition will be double-blinded through the use of a USB stick.\n\nCognitive stimulation will be a Mexican adaptation of the \"Memory Training and Cognitive Stimulation for Mild Cognitive Impairment\" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.\n\nIn total, each participant will receive 27 sessions of rTMS and 21 sessions of CS.",[15],{"type":32,"name":21,"description":40,"armGroupLabels":41,"otherNames":35},"In the first phase each participant will receive 15 sessions of tDCS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of tDCS and 1 session of CS per week for 12 weeks. Each session will consist of the delivery of a weak direct current of 2mA for 30 minutes.\n\ntDCS will be administered by the Sooma tDCS stimulator. The tDCS condition will be double-blinded, and a third operator will program the stimulator.\n\nCognitive stimulation will be a Mexican adaptation of the \"Memory Training and Cognitive Stimulation for Mild Cognitive Impairment\" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.\n\nIn total, each participant will receive 27 sessions of tCDS and 21 sessions of CS.",[21],{"type":32,"name":26,"description":43,"armGroupLabels":44,"otherNames":35},"In the first phase each participant will receive 15 sessions of tDCS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham tDCS and 1 session of CS per week for 12 weeks.\n\ntDCS will be administered by the Sooma tDCS stimulator. The sham condition will be double-blinded, and a third operator will program the stimulator.\n\nCognitive stimulation will be a Mexican adaptation of the \"Memory Training and Cognitive Stimulation for Mild Cognitive Impairment\" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.\n\nIn total, each participant will receive 27 sessions of Sham tDCS and 21 sessions of CS.",[26],[46],{"name":47,"affiliation":48,"role":49},"Ruth Alcalá Lozano, Dr.","Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz","PRINCIPAL_INVESTIGATOR",[51],{"name":47,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","5541605065","5065","ruthalcala@inprf.gob.mx",[57],{"facility":48,"status":58,"city":59,"state":35,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Mexico City","14370","Mexico","MX",{"type":64,"coordinates":65},"Point",[66,67],-99.12766,19.42847,{"lat":67,"lon":66},[70],{"name":47,"role":52,"phone":53,"phoneExt":54,"email":55},{"type":72,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100551989","comparison-of-two-non-invasive-neuromodulation-techniques-as-synergistic-therapy-to-cognitive-stimulation-in-amnestic-mild-cognitive-impairment-amci-100551989",false,"NCT06467253","Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)","Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI): Genetic Characterization, Proteins Associated With Neurogenesis, Clinical, Neuroimaging and Electrophysiological Markers","Inclusion criteria:\n\n* Being vaccinated against the SARS-COV2 virus.\n* Speak Spanish fluently.\n* Level of schooling greater than or equal to 6 years.\n* Amnestic mild cognitive impairment established by clinical examination performed by the treating physician (MoCA score: 19-25 points for probable aMCI) (based on the National Institute on Aging and Alzheimer's Association (NIA\u002FAA) criteria, 2011).\n* Adequate visual and auditory acuity to perform neuropsychological tests and cognitive rehabilitation.\n* If receiving psychotropic drugs, having started the drugs at least 12 weeks before the start of the study, remaining at stable doses, or having suspended the drugs for at least 4 weeks before the study.\n* Be in good health without non-psychiatric medical diseases (uncontrolled systemic arterial hypertension, diabetes mellitus or dyslipidemia, infections, thyroid disease, vitamin deficiency) interfering with the study.\n* Willingness to participate in a study scheduled for 8 weeks and that participants can go to the Instituto Nacional De Psiquiatría for treatments, as well as scheduled evaluations.\n* An informant to respond to some of the assessment questionnaires throughout the study and who would stay with the participant for at least 10 h\u002Fweek.\n\nExclusion Criteria:\n\n* Any neurological disease that raises suspicion of cognitive failure other than Alzheimer's disease, such as Parkinson's, multi-infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of trauma craniocerebral with loss of alertness.\n* Participants with a history of severe psychiatric disorders according to DSM-5 (bipolar disorder, schizophrenia, chronic depression) or with psychotic features, agitation, or behavioral problems in the last three months that could lead to difficulties in meeting the protocol.\n* History of psychoactive substance abuse and current alcohol consumption with a pattern of abuse or dependence in the last two years.\n* Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist).\n* Participants with pacemakers, intracranial metal objects, or history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.\n* Participation in the last 6 months in a clinical study that involved neuropsychological assessment.","ALL","55 Years","85 Years",{"count":84,"type":85},60,"ESTIMATED","INTERVENTIONAL",[88],"NA","This is a comparative, double-blind, randomized controlled clinical trial for people with Amnestic Mild Cognitive Impairment. The investigators will compare the effects of two non-invasive neuromodulation techniques (Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation) combined with cognitive stimulation. These non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare non-invasive techniques with cognitive stimulation CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow the investigators to characterize the participants; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells and solubles factors of serum; 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex by means of structural magnetic resonance imaging and the default mode network by means of functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude and latency in order to generate a response-to-treatment biomarker with neuromodulators in Mild Cognitive Impairment (MCI) and changes in electroencephalogram.",[91],"Mild Cognitive Impairment",[93,94,95,96,97,98],"Mild cognitive impairment","Repetitive Transcranial Magnetic Stimulation rTMS","Transcranial Direct Current Stimulation tDCS","Neuromodulation Techniques","Amnestic Mild Cognitive Impairment","Cognitive Stimulation","2024-06-19",{"date":101,"type":102},"2024-06-20","ACTUAL",{"date":104,"type":102},"2023-06-01",{"date":106,"type":85},"2027-06-15",{"name":5,"class":6},1]