Using brain stimulation to improve memory in people with mild cognitive impairment

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

This study is testing if a type of brain stimulation can help improve memory and thinking skills in older adults with mild cognitive impairment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Centre for Addiction and Mental Health (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06783283 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial alternating current stimulation (tACS) on enhancing working memory and cognitive functions in individuals diagnosed with Mild Cognitive Impairment (MCI). Participants aged 60 and older will receive non-invasive brain stimulation sessions lasting 1 to 1.5 hours, five days a week for two weeks at the Centre for Addiction and Mental Health. The study aims to assess the feasibility and preliminary effects of tACS on brain wave coupling and working memory performance. Clinical and cognitive assessments, along with bloodwork, will be conducted before and after the treatment period to evaluate outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 60 and older with a diagnosis of Mild Cognitive Impairment due to Alzheimer's disease.

Not a fit: Patients with dementia or those whose cognitive decline is due to vascular, traumatic, or other medical causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved cognitive function and delay the progression of Alzheimer's disease in patients with MCI.

How similar studies have performed: While the effects of tACS on working memory in healthy older adults have been documented, this specific application in MCI patients is novel and has not been previously tested.

Eligibility criteria

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)

Where this trial is running

Toronto, Ontario

• Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Sanjeev Kumar, MD — Centre for Addiction and Mental Health
• Study coordinator: Sanjeev Kumar, MD

Conditions Mild Cognitive Impairment; Memory Impairment; Executive Function; Transcranial Alternating Stimulation; Neuroplasticity; Electroencephalography; Working Memory; Cognition