AzTrials
AzTrials

Mild Cognitive Impairment (MCI)tACS-MCINCT06783283

TACS to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With MCI (tACS-MCI)

A study testing Transcranial Alternating Current Stimulation in people with Mild Cognitive Impairment (MCI), run by Centre for Addiction and Mental Health at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment (MCI)
What is being tested?
Transcranial Alternating Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteCanada
Study dates
2 Jan 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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,
  • Ability to read and communicate in English (with corrected vision and hearing, if needed)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4

    Sanjeev Kumar, MD, 416-535-8501 ext. 39384, Sanjeev.Kumar@camh.ca

    Recruiting

Other trials in Canada

About this study

Official title: Transcranial Alternating Current Stimulation to Engage Theta-Gamma Coupling and Enhance Working Memory in Patients With Mild Cognitive Impairment

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.

Read the detailed description

Current treatments for Alzheimer's disease dementia (AD) have limited efficacy probably because by the time AD is manifest it is too late to intervene. Thus, discovering interventions that will prevent AD is highly needed.

Mild Cognitive Impairment (MCI) is a condition that is considered a pre-stage to AD. In MCI, the frontal part of the brain supports the ability to compensate for memory problems which could delay progression to AD. This compensation is supported by "flexible" thinking which includes the ability to hold and manipulate information in mind for brief periods of time (e.g. doing mental math), also called working memory. Working memory has been shown by us and others to depend on the linking of brain waves across multiple brain waves frequencies.

Transcranial Alternating Current Stimulation (tACS) is a non-invasive electrical stimulation, applied to the scalp, that has been shown to improve this linking of brain waves in healthy older individuals. It has also been shown to enhance working memory in older individuals when this linking is enhanced. The effect of tACS on working memory and linking of brain waves in patients with MCI has not been demonstrated yet.

The study investigators propose to study the feasibility and preliminary effects of tACS on TGC and working memory in MCI participants. This proof-of-concept study will test whether tACS engages TGC as a target and, in turn, enhances working memory. Additionally, the investigators will explore the relationship among tACS effects and stress neuroreactivity and neuroimmune/inflammatory response (i.e., the interaction between the nervous system and the immune system), as well as the potential links with working memory.

If successful, our project will serve as a model for a larger trial to confirm the ability of tACS to prevent AD over multiple years of follow-up.

Objective 1: To determine the feasibility of tACS in older individuals with MCI. The investigators will examine recruitment and retention. Hypothesis 1a: At least 30% of screened participants will agree and be eligible to receive the intervention they are assigned to, i.e., tACS. Hypothesis 1b: At least 70% of participants will attend at least 80% of their treatment sessions.

Objective 2: To determine TGC engagement in response to tACS. The investigators will assess whether TGC increases in response to tACS. Hypothesis 2: Participants randomized to tACS will experience higher increase in TGC than those randomized to sham-tACS.

Objective 3: To determine change in working memory in response to tACS, and whether changes in TGC mediate changes in N-back performance with 2-back d' being the primary N-back outcome measure. Hypothesis 3a: Participants randomized to tACS will experience more improvement on N-back from baseline following the intervention than those randomized to sham-tACS. Hypothesis 3b: Across all participants, change in TGC will mediate change in N-back performance.

Exploratory Objective 4: To explore the relationships among tACS effects and stress neuroreactivity and neuroimmune/inflammatory response, as well as the potential links with working memory. Exploratory Hypothesis 4a: Baseline measure of stress neuroreactivity (i.e., salivary α-amylase and cortisol levels) will moderate response to tACS vs. sham-tACS. Exploratory Hypothesis 4b: Baseline measure of neuroimmune/inflammatory response (i.e., s100B, NSE, and MBP / IL-1β, IL-6, CRP, and TNF-α) will moderate response to tACS vs. sham-tACS. Exploratory Hypothesis 4c: Participants randomized to tACS will experience better stress neuroreactivity (i.e., salivary α-amylase and cortisol levels) from baseline following the intervention than those randomized to sham-tACS. Exploratory Hypothesis 4d: Participants randomized to tACS will experience better neuroimmune/inflammatory response (i.e., s100B, NSE, and MBP / IL-1β, IL-6, CRP, and TNF-α) from baseline following the intervention than those randomized to sham-tACS.

Exploratory Mediation Hypothesis: Across all participants, changes in stress neuroreactivity (i.e., salivary α-amylase and cortisol levels) and neuroimmune/inflammatory response (i.e., s100B, NSE, and MBP /I L-1β, IL-6, CRP, and TNF-α) will mediate change in TGC, N-back performance, and working memory.

Being tested
Transcranial Alternating Current Stimulation, Sham tACS
Keywords
Memory Impairment, Executive Function, Transcranial Alternating Stimulation, Neuroplasticity, Electroencephalography, Working Memory, Cognition, Prefrontal Cortex, Transcranial Electrical Stimulation, Dementia, Alzheimer's Disease, Temporal Cortex
Medical subject headings
Cognitive Dysfunction, Memory Disorders, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Alternating Current StimulationDevice

    Also called tACS

    Transcranial Alternating Current Stimulation (tACS) is a non-invasive electrical stimulation that will be used to stimulate the dorsolateral prefrontal cortex (dlPFC) and temporal cortices and in turn enhance Theta-Gamma Coupling (TGC) and working memory in Mild Cognitive Impairment (MCI). Each participant will receive daily stimulation for 10 days. To deliver the tACS, multiple electrodes embedded in a cap placed on the participant's head. Sham-tACS will follow the same procedure.

  • Sham tACSDevice

    During sham-tACS, the device will ramp up to the desired intensity over 60 seconds, and then will immediately ramp down, and the stimulation will be shut off, until the end of the session. At the end of the session, the device will again ramp up for 60 seconds and then ramp down. Sham-tACS will also target dlPFC and temporal cortices (similar to active). Each participant will receive daily sham-tACS for 10 days. To deliver the sham-tACS, multiple electrodes will be embedded in a cap placed on the participant's head.

Study groups in NCT06783283
Study groupRoleWhat they receive
Active tACSActive comparatorAfter completing the Baseline testing at Visit 1 and N-back EEG at Visit 2, MCI participants randomized to the active condition will receive a 10-session course of tACS (Visits 4-13), followed by a follow-up assessment, post intervention, at Visit 14.
Receives: Device: Transcranial Alternating Current Stimulation
Sham tACSSham comparatorAfter completing the Baseline testing at Visit 1 and N-back EEG at Visit 2, MCI participants randomized to the sham condition will receive a 10-session course of sham-tACS (Visits 4-13), followed by a follow-up assessment, post intervention, at Visit 14.
Receives: Device: Sham tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of All Screened Participants

    Recruitment (percentage of all screened participants) will be examined.

    Hypothesis: At least 30% of screened participants will agree and be eligible to receive the intervention they are assigned to, i.e., tACS.

    Measured: Through treatment completion, at the end of 2-week intervention.

  2. Percentage of All Enrolled Participants

    Retention will be examined. Hypothesis: At least 70% of participants will attend at least 80% of their treatment sessions.

    Measured: Through treatment completion, at the end of 2-week intervention.

Secondary outcomes (3)
  1. Theta-gamma Coupling

    The modulation index obtained from the EEG recording during N-Back

    Measured: Through treatment completion, at the end of 2-week intervention.

  2. N-Back

    Cognitive test via EEG measured by d', a sensitivity index based on the z scores of the hit and false alarm rates using the following formula: d' = z(H)- z(FA) where H is the hit rate and FA is the false alarm rate.

    Measured: Through treatment completion, at the end of 2-week intervention.

  3. Mediation of TGC on changes in N-back performance

    The beta value generated by Linear Model examining the association between changes in TGC and changes in N-back performance.

    Measured: Through treatment completion, at the end of 2-week intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start2 Jan 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In a 1x1 factorial Randomized Controlled Trial (RCT), the investigators will randomize 20 MCI participants to one of the two treatment arms: tACS and sham-tACS, with 10 participants in each group. tACS will be delivered bilaterally to the PFC and temporal cortices. Each participant will receive daily stimulation for 10 days. Working memory and TGC during working memory performance will be assessed at baseline and following the last day of the study intervention. Working memory will be assessed using the N-back task and TGC using EEG during N-back performance.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06783283
Sponsor's protocol ID
056-2023
Acronym
tACS-MCI
Status last verified
Apr 2026
First submitted
12 Dec 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication can be shared upon a reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Alternating Current Stimulation in people with Mild Cognitive Impairment (MCI), run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sanjeev Kumar, MD (416-535-8501 ext. 39384, Sanjeev.Kumar@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of All Screened Participants (time frame: Through treatment completion, at the end of 2-week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in