Comparing two non-invasive brain stimulation techniques for mild cognitive impairment
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
This study is testing two different brain stimulation techniques to see if they can help people with mild cognitive impairment improve their thinking skills and possibly delay dementia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06467253 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Spanish-speaking individuals aged 60 and older with a diagnosis of Amnestic Mild Cognitive Impairment.
Not a fit: Patients with significant non-psychiatric medical conditions or those not meeting the cognitive impairment criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new non-invasive treatment options to improve cognitive function and delay the progression of dementia in patients with mild cognitive impairment.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques for cognitive enhancement, but this specific comparative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mexico City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.