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.
Alzheimer disease
cognitive
cognitive impairment
crossover
dementia
double blind
placebo-controlled
randomized
transcranial alternating current stimulation
treatment
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
27 Apr 2022
27 Apr 2022
Historique:
received:
14
02
2022
accepted:
01
03
2022
revised:
01
03
2022
entrez:
27
4
2022
pubmed:
28
4
2022
medline:
28
4
2022
Statut:
epublish
Résumé
Although memory and cognitive declines are associated with normal brain aging, they may also be precursors to dementia. 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. 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-Åsberg 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. 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. 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. Clinicaltrials.gov NCT05203523; https://clinicaltrials.gov/show/NCT05203523. DERR1-10.2196/37282.
Sections du résumé
BACKGROUND
BACKGROUND
Although memory and cognitive declines are associated with normal brain aging, they may also be precursors to dementia.
OBJECTIVE
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
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-Åsberg 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
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
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
BACKGROUND
Clinicaltrials.gov NCT05203523; https://clinicaltrials.gov/show/NCT05203523.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/37282.
Identifiants
pubmed: 35475789
pii: v11i4e37282
doi: 10.2196/37282
pmc: PMC9096654
doi:
Banques de données
ClinicalTrials.gov
['NCT05203523']
Types de publication
Journal Article
Langues
eng
Pagination
e37282Informations de copyright
©Natasha Jacobson, Brian Lithgow, Mohammad Jafari Jozani, Zahra Moussavi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.04.2022.
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