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