Exploring brain mechanisms related to personal memory
Understanding Brain Mechanisms Involved in Autobiographical Memory Using High-density Electroencephalography and Transcranial Alternating Current Stimulation
This study is testing how brain activity related to personal memories works in people with mild cognitive impairment compared to healthy older and younger adults, and whether a special brain stimulation can change this activity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT05710549 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate the brain activity associated with autobiographical memory (ABM) in individuals with mild cognitive impairment (MCI) and healthy participants. Using high-density electroencephalography (hdEEG), the study will analyze the brain oscillations and networks involved in ABM. Additionally, non-invasive brain stimulation techniques, specifically transcranial alternating current stimulation (tACS), will be applied to understand how these brain rhythms can be modulated. The research will compare MCI patients with age-matched healthy older adults and younger healthy participants to uncover the neurophysiological mechanisms underlying memory disturbances.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 55 and older with a clinical diagnosis of mild cognitive impairment and those without cognitive impairment aged 18 to 35 or 55 and older.
Not a fit: Patients with severe cognitive impairment or those not meeting the specific age and cognitive criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential interventions for memory loss in patients with mild cognitive impairment and Alzheimer's disease.
How similar studies have performed: Other studies have shown promise in using non-invasive brain stimulation techniques to enhance cognitive functions, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cognitively-Unimpaired Younger and Older Adults * Age 18 to 35 years old (younger adults) * Age 55+ years old (older adults) * without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA) * willing and capable to give informed consent for participation in the study after it has been thoroughly explained able * willing to comply with all study requirements informed consent form was signed Mild Cognitive Impairment (MCI) patients * Age 55+ years old * Clinical Diagnosis of MCI * Confirmation of diagnosis will be made by the study MD based on a holistic consideration of the participant's cognitive evaluation and history * Mini-Mental State Examination (MMSE) ≥ 18 (Mild AD ≥ 21) * CDR ≥ .5 * Demonstration or history of autobiographical memory impairments * On a stable dose of medications for memory loss including cholinesterase inhibitors (e.g. donepezil, rivastigmine) or memantine as defined as 6 consecutive weeks of treatment at an unchanging dose * Minimum of completed 8th-grade education * willing and capable to give informed consent for participation in the study after it has been thoroughly explained - note that to ensure this in the case of the MCI participants, a cut-off of MOCA score \>18 will be applied * able and willing to comply with all study requirements informed consent form was signed Exclusion Criteria: Cognitively-Unimpaired Younger and Older Adults * any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26 * major psychiatric co-morbidity including major depressive disorder, schizophrenia, or psychosis * blindness or other disabilities that prevent task performance * Contraindication for undergoing MRI * Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement) Mild Cognitive Impairment (MCI) patients * Age \< 55 years old * Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major 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, or immediate (1st-degree relative) family history of epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist * Any unstable medical condition or chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) or study complication * contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp * Contraindication for undergoing MRI or receiving tACS * Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement) * Any devices such as a pacemaker, medication pump, nerve stimulator, TENS unit, ventriculoperitoneal shunt unless cleared by the responsible covering MD
Where this trial is running
Geneva, Canton of Geneva
- University of Geneva, Campus Biotech — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lucie Bréchet, PhD — University of Geneva (UNIGE)
- Study coordinator: Lucie Bréchet, PhD
- Email: lucie.brechet@unige.ch
- Phone: +41 22 379 08 52
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.