Improvement of Memory in Mild Cognitive Impairment

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment
• Interventions: Device: transcranial alternating current stimulation (tACS); Diagnostic Test: Montreal Cognitive Assessment (MoCA); Device: high-density electroencephalography (hdEEG)

• Registration Number: NCT05708001
• Lead Sponsor: Prof. Christoph M. Michel

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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-22
• Study Start: 2023-02-01
• Study First Posted: 2023-02-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-05
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial alternating current stimulation (tACS)	transcranial alternating current stimulation (tACS)	The randomized, sham-controlled, parallel-arm, double-blind clinical trial will include 12 weeks of daily, home-based stimulation sessions. MCI patients will be randomly assigned to the active or sham group.
clinical measures (MoCA)	Montreal Cognitive Assessment (MoCA)	At the baseline, after the first 4 weeks, and at the end of 12 weeks, MCI patients will be evaluated in the laboratory using MoCA.
neurophysiological (hdEEG)	high-density electroencephalography (hdEEG)	At the baseline, after the first 4 weeks, and at the end of 12 weeks, MCI patients will be evaluated in the laboratory using hdEEG.

Primary Outcome Measures

Name	Time	Method
cognitive status measured by Montreal Cognitive Assessment (MoCA)	baseline, after 4 weeks, after 12 weeks	The primary objective is to characterize cognitive status at baseline, after 4 weeks and after 12 weeks of the home-based stimulation intervention.

Secondary Outcome Measures

Name	Time	Method
modulation of gamma activity assessed with high-density EEG	baseline, after 4 weeks, after 12 weeks	The secondary objective is to assess with hdEEG any changes in gamma power at baseline, after 4 weeks and after 12 weeks of the home-based stimulation intervention.

Trial Locations

Locations (1)

University of Geneva, Campus Biotech; 🇨🇭 Geneva, Switzerland