Improvement of Memory in Mild Cognitive Impairment (MCI) Using Transcranial Alternating Current Stimulation (tACS) Guided by EEG and MRI: a Randomized, Sham-controlled, Parallel-arm, Double-blind Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Lucie Bréchet
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- cognitive status measured by Montreal Cognitive Assessment (MoCA)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The Clinical Trial will systematically examine the feasibility of remote, caregiver-led tACS for older adults with memory deficits and evaluate whether repeated tACS leads to sustained improvement of neuronal activity and memory functions.
Detailed Description
The proposed investigation will systematically examine the feasibility and efficacy of remote, caregiver-led tACS for older adults with memory decline. This study will provide data to support the safety and effectiveness of home-based tACS in this population and will lead to future research to increase access to tACS as a part of memory decline prevention and treatment for older adults.
Investigators
Lucie Bréchet
Sponsor-Investigator
University of Geneva, Switzerland
Eligibility Criteria
Inclusion Criteria
- •Mild Cognitive Impairment (MCI) patients
- •age ≥ 55 years old
- •clinical diagnosis of mild cognitive impairment (MCI) based on a comprehensive clinical assessment and standard neuropsychological examination including tests of language, visuospatial thinking, executive functions, and memory
- •confirmation of diagnosis will be made by Prof. Paul Unschuld, the study MD, based on a participant's cognitive evaluation and history
- •understanding of the informed consent
- •able and willing to comply with all study requirements
- •informed consent form was signed
- •women of childbearing potential (WOCBP) must perform a pregnancy test during screening
- •minimum 21 years of age
- •self-reported computer/tablet proficiency
Exclusion Criteria
- •Mild Cognitive Impairment (MCI) patients
- •age \< 55 years old
- •any current diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder, depressive disorder)
- •other than MCI, any history of other progressive or genetic neurologic disorder (e.g., Parkinson's disease, multiple sclerosis, tubular sclerosis) or acquired neurological disease (e.g., stroke, traumatic brain injury, tumor), including intracranial lesions
- •history of head trauma resulting in prolonged loss of consciousness
- •current history of poorly controlled headaches including chronic medication for migraine prevention
- •history of fainting spells of unknown or undetermined etiology that might constitute seizures
- •history of seizures, diagnosis of epilepsy
- •any unstable medical condition or chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- •contraindication for undergoing MRI or receiving tACS
Outcomes
Primary Outcomes
cognitive status measured by Montreal Cognitive Assessment (MoCA)
Time Frame: baseline, after 4 weeks
The primary objective is to characterize cognitive status at baseline and after 4 weeks of the home-based stimulation intervention.
Secondary Outcomes
- modulation of gamma activity assessed with high-density EEG(baseline, after 4 weeks,)