NCT06467253 · RECRUITING

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

This trial is testing two types of non-invasive brain stimulation — repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) — each paired with structured cognitive exercises, in people with amnestic mild cognitive impairment. Researchers want to see which combination best supports memory and brain function. This is a Phase NA (feasibility or exploratory) trial, meaning it is designed to gather early data, not to prove a treatment works definitively.

You may qualify if

  • 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.

You're excluded if

  • 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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2024-06-20

View full record on ClinicalTrials.gov

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