Comparing two non-invasive brain stimulation techniques for mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effects of two non-invasive neuromodulation techniques, Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS), in conjunction with cognitive stimulation for individuals with Amnestic Mild Cognitive Impairment (aMCI). Participants will be randomly assigned to receive one of the four treatment combinations, including sham treatments, and will undergo clinical and neuropsychological evaluations throughout the study. The trial also seeks to characterize participants based on clinical risk factors and genetic biomarkers, as well as document biological effects related to neurogenesis. The goal is to explore effective interventions that could delay or prevent the onset of dementia in at-risk populations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
  Mexico City, Mexico Recruiting

Study contacts

• Principal investigator: Ruth Alcalá Lozano, Dr. — Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
• Study coordinator: Ruth Alcalá Lozano, Dr.
• Email: ruthalcala@inprf.gob.mx
• Phone: 5541605065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.