Clinical trial NCT05708001: Improvement of Memory in Mild Cognitive Impairment
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: autobiographical memory (ABM)
memory and cognition
transcranial alternating current stimulation (tACS)
high-density electroencephalography (hdEEG)
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. Giovanni Frisoni, 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

Caregiver

* minimum 21 years of age
* self-reported computer/tablet proficiency
* willingness to learn how to use tACS
* availability during the study period to administer tACS to the participant
* informed consent form was signed
* women of childbearing potential (WOCBP) must perform a pregnancy test during screening

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
* 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 skin problems, such as dermatitis, psoriasis, or eczema
* any electrically, magnetically, or mechanically activated implanted devices such as a pacemaker, intracranial electrodes, implanted defibrillators, medication pumps, nerve stimulators, vascular clips, or any other prosthesis in the brain
* any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease, or active neoplasia
* pregnant women
* adults lacking capacity for consent

Caregiver

* insufficient understanding of study procedures
* poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS

Primary outcomes:
measure: cognitive status measured by Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, after 4 weeks, after 12 weeks
Secondary outcomes:
measure: modulation of gamma activity assessed with high-density EEG
timeFrame: baseline, after 4 weeks, after 12 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva, Campus Biotech
Study officials:
affiliation: University of Geneva (UNIGE)
name: Christoph Michel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geneva University Hospitals (HUG)
name: Giovanni Frisoni, PhD
role: STUDY_CHAIR
References:
citation: Brechet L, Brunet D, Birot G, Gruetter R, Michel CM, Jorge J. Capturing the spatiotemporal dynamics of self-generated, task-initiated thoughts with EEG and fMRI. Neuroimage. 2019 Jul 1;194:82-92. doi: 10.1016/j.neuroimage.2019.03.029. Epub 2019 Mar 19.
citation: Brechet L, Michel CM, Schacter DL, Pascual-Leone A. Improving autobiographical memory in Alzheimer's disease by transcranial alternating current stimulation. Curr Opin Behav Sci. 2021 Aug;40:64-71. doi: 10.1016/j.cobeha.2021.01.003. Epub 2021 Feb 14.
citation: Brechet L, Yu W, Biagi MC, Ruffini G, Gagnon M, Manor B, Pascual-Leone A. Patient-Tailored, Home-Based Non-invasive Brain Stimulation for Memory Deficits in Dementia Due to Alzheimer's Disease. Front Neurol. 2021 May 20;12:598135. doi: 10.3389/fneur.2021.598135. eCollection 2021.
citation: Benussi A, Cantoni V, Grassi M, Brechet L, Michel CM, Datta A, Thomas C, Gazzina S, Cotelli MS, Bianchi M, Premi E, Gadola Y, Cotelli M, Pengo M, Perrone F, Scolaro M, Archetti S, Solje E, Padovani A, Pascual-Leone A, Borroni B. Increasing Brain Gamma Activity Improves Episodic Memory and Restores Cholinergic Dysfunction in Alzheimer's Disease. Ann Neurol. 2022 Aug;92(2):322-334. doi: 10.1002/ana.26411. Epub 2022 Jun 6.