Recruiting

tACS

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06783283

Conditions

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Transcranial Alternating Current Stimulation

Sham tACS

Study Details

Brief 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.

Conditions

Mild Cognitive Impairment (MCI)

Study ID

NCT06783283

Start date

Jan 2, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 60 years or above,
2. 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:

1. Cognitive concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
2. Not demented ascertained using the study investigator opinion.
3. No vascular, traumatic, or medical causes of cognitive decline ascertained using the study investigator opinion.
4. Evidence of longitudinal decline in cognition, when feasible, and ascertained using the study investigator opinion.
3. 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.
4. Willingness to provide informed consent,
5. Ability to read and communicate in English (with corrected vision and hearing, if needed)

Exclusion Criteria:

1. Current use of an acetylcholine esterase inhibitor or memantine ascertained via participant's report, Medication List, or Electronic Medical Record (EMR).
2. 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.
3. A lifetime diagnosis of bipolar disorder; intellectual disability; or a psychotic disorder ascertained using the MINI or SCID, or EMR.
4. Substance use disorder active in the last 3 months ascertained using the MINI or SCID, or EMR.
5. 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.
6. 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.
7. 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
8. Any contraindication to MRI or contraindication to tACS (e.g., cardiac pacemaker, acoustic device, history of seizures) ascertained using the tACS Safety Screen (tSS)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active tACS

After 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.

sham comparator: Sham tACS

After 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.

Interventions

Transcranial Alternating Current Stimulation

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 tACS

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.

Primary outcome measure

  • Percentage of All Screened Participants [ Time Frame: Through treatment completion, at the end of 2-week intervention. ]
  • Percentage of All Enrolled Participants [ Time Frame: Through treatment completion, at the end of 2-week intervention. ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Memory Impairment
  • Executive Function
  • Transcranial Alternating Stimulation
  • Neuroplasticity
  • Electroencephalography
  • Working Memory
  • Cognition
  • Prefrontal Cortex
  • Transcranial Electrical Stimulation
  • Dementia
  • Alzheimer's Disease
  • Temporal Cortex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-04-13.