PMID- 35475789 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220716 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 11 IP - 4 DP - 2022 Apr 27 TI - The Effect of Transcranial Alternating Current Stimulation With Cognitive Training on Executive Brain Function in Individuals With Dementia: Protocol for a Crossover Randomized Controlled Trial. PG - e37282 LID - 10.2196/37282 [doi] LID - e37282 AB - BACKGROUND: Although memory and cognitive declines are associated with normal brain aging, they may also be precursors to dementia. OBJECTIVE: We aim to offer a novel approach to prevent or slow the progress of neurodegenerative dementia, or plausibly, improve the cognitive functions of individuals with dementia. METHODS: We will recruit and enroll 75 participants (older than 50 years old with either mild cognitive impairment or probable early or moderate dementia) for this double-blind randomized controlled study to estimate the efficacy of active transcranial alternating current stimulation with cognitive treatment (in comparison with sham transcranial alternating current stimulation). This will be a crossover study; a cycle consists of sham or active treatment for a period of 4 weeks (5 days per week, in two 30-minute sessions with a half-hour break in between), and participants are randomized into 2 groups, with stratification by age, sex, and cognitive level (measured with the Montreal Cognitive Assessment). Outcomes will be assessed before and after each treatment cycle. The primary outcomes are changes in Wechsler Memory Scale Older Adult Battery and Alzheimer Disease Assessment Scale scores. Secondary outcomes 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 (visual 1-back task). Exploratory outcome measures will also be assessed: static and dynamic vestibular response using electrovestibulography, neuronal changes using functional near-infrared spectroscopy, and change in spatial orientation using virtual reality navigation. RESULTS: As of February 10, 2022, the study is ongoing: 7 patients have been screened, and all were deemed eligible for and enrolled in the study; 4 participants have completed baseline assessments. CONCLUSIONS: We anticipate that transcranial alternating current stimulation will be a well-tolerated treatment, with no serious side effects and with considerable short- and long-term cognitive improvements. TRIAL REGISTRATION: Clinicaltrials.gov NCT05203523; https://clinicaltrials.gov/show/NCT05203523. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37282. CI - (c)Natasha Jacobson, Brian Lithgow, Mohammad Jafari Jozani, Zahra Moussavi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.04.2022. FAU - Jacobson, Natasha AU - Jacobson N AUID- ORCID: 0000-0002-7282-7846 AD - Department of Electrical and Computer Engineering, University of Manitoba, Winnipeg, MB, Canada. FAU - Lithgow, Brian AU - Lithgow B AUID- ORCID: 0000-0002-4608-7944 AD - Department of Electrical and Computer Engineering, University of Manitoba, Winnipeg, MB, Canada. AD - Monash Alfred Psychiatry Research Centre, Monash University Central Clinical School, Melbourne, Australia. FAU - Jafari Jozani, Mohammad AU - Jafari Jozani M AUID- ORCID: 0000-0002-2147-6337 AD - Department of Statistics, University of Manitoba, Winnipeg, MB, Canada. FAU - Moussavi, Zahra AU - Moussavi Z AUID- ORCID: 0000-0001-9202-949X AD - Department of Electrical and Computer Engineering, University of Manitoba, Winnipeg, MB, Canada. LA - eng SI - ClinicalTrials.gov/NCT05203523 PT - Journal Article DEP - 20220427 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC9096654 OTO - NOTNLM OT - Alzheimer disease OT - cognitive OT - cognitive impairment OT - crossover OT - dementia OT - double blind OT - placebo-controlled OT - randomized OT - transcranial alternating current stimulation OT - treatment COIS- Conflicts of Interest: ZM holds the copyright of the MindTriggers app, which is one of the tools used in this study; however, none of the participants are required to purchase the app because practice is conducted onsite where the app is provided for them. EDAT- 2022/04/28 06:00 MHDA- 2022/04/28 06:01 PMCR- 2022/04/27 CRDT- 2022/04/27 12:08 PHST- 2022/02/14 00:00 [received] PHST- 2022/03/01 00:00 [accepted] PHST- 2022/03/01 00:00 [revised] PHST- 2022/04/27 12:08 [entrez] PHST- 2022/04/28 06:00 [pubmed] PHST- 2022/04/28 06:01 [medline] PHST- 2022/04/27 00:00 [pmc-release] AID - v11i4e37282 [pii] AID - 10.2196/37282 [doi] PST - epublish SO - JMIR Res Protoc. 2022 Apr 27;11(4):e37282. doi: 10.2196/37282.