Actively Recruiting
Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)
Led by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente · Updated on 2024-06-20
60
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 to neurogenesis from olfactory epithelial neural progenitor cells and solubles factors of serum; 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex by means of structural magnetic resonance imaging and the default mode network by means of functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude and latency in order to generate a response-to-treatment biomarker with neuromodulators in Mild Cognitive Impairment (MCI) and changes in electroencephalogram.
CONDITIONS
Official Title
Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be vaccinated against the SARS-COV2 virus.
- Speak Spanish fluently.
- Have at least 6 years of schooling.
- Have amnestic mild cognitive impairment confirmed by clinical examination (MoCA score 19-25) based on NIA/AA criteria.
- Have adequate vision and hearing to complete neuropsychological tests and cognitive rehabilitation.
- If taking psychotropic drugs, have been on stable doses for at least 12 weeks or have stopped them at least 4 weeks before the study.
- Be in good health without uncontrolled medical diseases that interfere with the study.
- Be willing to participate in an 8-week study and attend scheduled treatments and evaluations at the Instituto Nacional De Psiquiatría.
- Have an informant who can respond to assessment questionnaires and stay with the participant at least 10 hours per week.
You will not qualify if you...
- Have neurological diseases other than Alzheimer's disease that may cause cognitive failure.
- Have severe psychiatric disorders in the last 3 months that could interfere with study participation.
- Have a history of psychoactive substance abuse or alcohol dependence in the last 2 years.
- Have abnormalities in a conventional electroencephalogram.
- Have pacemakers, intracranial metal objects, history of brain surgery, aneurysm clips, artificial heart valves, ear implants, or metal fragments or foreign objects in body tissues.
- Have participated in a neuropsychological clinical study in the last 6 months.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
Mexico City, Mexico, 14370
Actively Recruiting
Research Team
R
Ruth Alcalá Lozano, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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