JMIR Publications

ABSTRACT

Background:

Though memory and cognitive declines are associated with normal brain aging, they may also be precursors to dementia. While there currently exists no cure or "vaccine" against dementia, there are hopes to delay the onset of the disease by living a brain-healthy lifestyle. The present research protocol offers a novel approach to prevent or slow the progress of neurodegenerative dementia, or plausibly improve the cognitive functions of individuals with dementia. In this study, the efficacy of tutored cognitive training paired simultaneously with either active or sham transcranial alternating current stimulation (tACS) is investigated in a randomized, controlled, double-blind, cross-over protocol.

Objective:

The objectives are to (1) recruit and enroll 75 eligible participants, (2) estimate the efficacy of active tACS versus sham when paired with cognitive treatment at post-intervention, (3) estimate the duration of treatment effects amongst responders, (4) estimate the effect of dementia severity on treatment response, (5) explore applications of novel technologies for predicting a patient’s response to treatment at baseline, as well as monitoring treatment’s outcomes.

Methods:

A randomized, controlled, double-blind, cross-over, in-person study has been designed to evaluate the short- and long-term benefits of active tACS treatment compared to sham tACS treatment simultaneously paired with structured tutored cognitive training on the dementia population. Treatment occurs over the course of 4 weeks, 5 days per week, in two 30 min sessions with a half-hour break in between. Participants must have either mild cognitive impairment or probable early or moderate dementia type and be greater than 50 years old. Study participants are randomized into two groups by their age, sex, and cognitive level as measured by Montreal Cognitive Assessment. The primary outcome measures are the change in the Wechsler Memory Scale (WMS-IV) Older Adult Battery and Alzheimer Disease Assessment Scale (ADAS-Cog) score from baseline to post-treatment. Secondary outcome measures are changes in performance on tests of frontal lobe functioning (verbal fluency), neuropsychiatric symptoms (Neuropsychiatric Inventory Questionnaire), mood changes (Montgomery-Asberg Depression Rating Scale), and short-term recall (1-Back). Exploratory outcome measures consider static and dynamic vestibular response using Electrovestibulography (EVestG), neuronal changes using functional near infrared spectroscopy (fNIRS), and change in spatial orientation using virtual reality navigation (VRN). Participants are assessed before and after each cycle of the cross-over study.

Results:

As of February 10, 2022, 7 patients were screened, of whom all were deemed eligible and enrolled in the study. Enrolled participants were randomized into intervention groups, with 4 having completed their baseline assessment. It is anticipated that tACS be a well-tolerated treatment with no serious side effects and considerable cognitive improvement.

Conclusions:

This protocol design addresses both the short- and long-term effects of tACS, when compared with sham treatment in a large study sample. Clinical Trial: Clinicaltrials.gov NCT05203523; https://clinicaltrials.gov/show/NCT05203523