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.
Age 60 years or above,
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.
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.
Parallel
Transcranial Alternating Current Stimulation
DeviceTranscranial 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
DeviceDuring 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.
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.
Percentage of All Enrolled Participants
Retention will be examined. Hypothesis: At least 70% of participants will attend at least 80% of their treatment sessions.
Theta-gamma Coupling
The modulation index obtained from the EEG recording during N-Back
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.
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.
PASAT
Modified Paced Auditory Serial Addition Test (PASAT) test total correct responses across both types of trials
Neuroimmune response
Measured by concentration of s100B, NSE (pg/mL) in blood sample
Neuroimmune response
Measured by concentration of MBP (ng/mL) in blood sample.
Inflammatory response
Measured by concentration of IL-1β, IL-6, CRP, and TNF-α (pg/mL) in salivary sample.
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Centre for Addiction and Mental Health
Lead sponsor
Soterix Medical
Collaborator
