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Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)

RecruitingNAAges 55 Years - 85 YearsAllInstituto Nacional de Psiquiatría Dr. Ramón de la…
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion criteria: * Being vaccinated against the SARS-COV2 virus. * Speak Spanish fluently. * Level of schooling greater than or equal to 6 years. * 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/AA) criteria, 2011). * Adequate visual and auditory acuity to perform neuropsychological tests and cognitive rehabilitation. * 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. * 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. * 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. * 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/week. Exclusion Criteria: * 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. * 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. * History of psychoactive substance abuse and current alcohol consumption with a pattern of abuse or dependence in the last two years. * Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist). * 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. * Participation in the last 6 months in a clinical study that involved neuropsychological assessment.
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What it tests

  • 1. rTMS + CS
  • 2. rTMS Sham + CS
  • 3. tDCS + CS
  • 4. tDCS Sham + CS
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Where

1 site
Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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