TACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI) (NCT06783283) | Clinical Trial Compass
RecruitingNot Applicable
TACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI)
Canada20 participantsStarted 2025-01-02
Plain-language summary
This study is looking at a new non-invasive brain stimulation methods called transcranial alternating current stimulation (tACS) to see if it can improve working memory and thinking processes in people with Mild Cognitive Impairment (MCI). tACS is a low-risk, non-painful, low electrical current that circulates through the brain of awake participants and stimulates their brain cells. Participants must be 60 years of age and have a diagnosis of mild cognitive impairment. Participants will undergo treatment sessions that range from 1 to 1.5 hours at CAMH, 5 days a week, over a total of 2 weeks. In addition, participants will complete clinical and cognitive assessments and bloodwork at baseline and again after treatment.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 60 years or above,
. Diagnosis of MCI due to AD using the core clinical criteria by the National Institute on Aging and Alzheimer's Association for MCI participants (NIA-AA) and ascertained by a study investigator. The following checklist will be used to ascertain the MCI diagnosis:
. Cognitive concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
. Not demented ascertained using the study investigator opinion.
. No vascular, traumatic, or medical causes of cognitive decline ascertained using the study investigator opinion.
. Evidence of longitudinal decline in cognition, when feasible, and ascertained using the study investigator opinion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring how many people can be successfully screened and enrolled rather than whether it actually improves memory — does that mean it's mainly a feasibility study to test whether the approach is practical, and not yet designed to tell us if tACS treatment works for MCI?
2Since this study uses transcranial alternating current stimulation to target theta-gamma brain wave coupling, what does my doctor know about the safety record of tACS in people with MCI, and are there any risks specific to my situation I should be aware of?
3Given that this trial is in an early feasibility phase, would my doctor recommend I consider established standard-of-care approaches for MCI first, or does participating in this trial fit alongside those options?
4What would actually be required of me if I were to discuss enrolling — how many visits, how long each session lasts, and is the stimulation device used in a clinic or somewhere else — and how might that fit into my current routine?
5If this trial is still building evidence about whether the approach is even practical to run, how would my doctor weigh the uncertainty of being in an early-stage study against any potential benefit I might hope for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of All Screened Participants
Timeframe: Through treatment completion, at the end of 2-week intervention.
2
Percentage of All Enrolled Participants
Timeframe: Through treatment completion, at the end of 2-week intervention.
. Objective evidence of single or multi domain MCI, where single domain MCI refers to deficits using neuropsychology (NP) battery on only one of the cognitive domains (Speed of Processing; Working Memory; Executive Functioning; Verbal Memory; Visual Memory; Language) and multi domain MCI refers to deficits in more than one of these domains. To determine impairment in one or more cognitive domain, after the NP battery is administered and double scored, a consensus meeting will be held with the Research Analyst/Fellow, the study Principal Investigator and the study Neuropsychologist during which eligibility will be discussed. The meeting attendees will take into consideration the participant's education, parental education, pre-morbid IQ, physician's assessment and NP scores to determine if the participant has impairment in one or more cognitive domain.
. Willingness to provide informed consent,
Exclusion criteria
. Current use of an acetylcholine esterase inhibitor or memantine ascertained via participant's report, Medication List, or Electronic Medical Record (EMR).
. Major Depressive Disorder with active symptoms in the last 3 months ascertained using the Mini International Neuropsychiatric Interview (MINI), or Structured Clinical Interview for DSM-5 (SCID), or EMR.
. A lifetime diagnosis of bipolar disorder; intellectual disability; or a psychotic disorder ascertained using the MINI or SCID, or EMR.
. Substance use disorder active in the last 3 months ascertained using the MINI or SCID, or EMR.
. Any other DSM-5 diagnosis ascertained using the MINI or SCID, or EMR, that may be associated with prefrontal cortical dysfunction as ascertained using a study investigator opinion.
. Current anticonvulsant use due to its impact on brain stimulation induced activity and ascertained using a Medication List or EMR. An exception will be made if they are taking gabapentin or pregabalin AND if the dose had been stable for at least 4 weeks prior to study entry AND if prescribed for chronic pain.
. Current benzodiazepine use of more than what is equivalent to lorazepam 2 mg/day as ascertained using a Medication List. This is due to their known pro-GABAergic activity and the suppressive effect of GABAergic agents on cortical plasticity
. Any contraindication to MRI or contraindication to tACS (e.g., cardiac pacemaker, acoustic device, history of seizures) ascertained using the tACS Safety Screen (tSS)