WAVE: AudioVisual Stimulation Enhances Cognitive, Mental and Physical Health in Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention Group: Gamma stimulation, Control Group: Theta stimulation.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Audiovisual Stimulation in Elderly (Older Adults?): Effects on Cognition, Depressive Symptoms, and Dual Motor-Cognitive Tasks - a RCT
Overview
The goal of this randomized controlled trial is to 1) carry out a screening of cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults; 2) analyze the influence of AVNS on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults. The main question it aims to answer is: "Does AVNS have influence on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults ". Participants will be randomly assigned to a control group or to a intervention group, where they will use AVNS to see if influences the above mentioned outcomes, compared to the no intervention (control) group.
Detailed description
Mild Cognitive Impairment (MCI) can be defined as a pre-dementia symptom and, when associated with aging, characterizes individuals with cognitive decline below the level of dementia. This decline, which can begin as early as 45 years of age, leads to impairments in memory, learning, language, orientation, and executive functions, which are more visible from the sixth decade of life onwards, with a risk of reduced autonomy and independence, and is seen by researchers as the first stage of a process of loss. This loss is progressive, lasting several years and resulting in MCI, characterized by objective cognitive loss, which does not yet compromise autonomy but has a conversion rate to dementia of 10% per year. Cognitive decline can be accompanied by increased depressive symptoms and decreased functional capacity and is related to inflammatory conditions, described in the literature as "inflammaging". Studies with beat stimulation have shown benefits in different important outcomes of cognitive function and depression. Thus, audiovisual neurostimulation (AVNS) is a possible non-pharmacological treatment that might have a direct influence on the brain wave patterns, altered in MCI and depression, modulating these specific wave frequencies to functional patterns similar to those found in healthy individuals. Having this, it can also influence agility and functional balance and reduce chronic inflammatory conditions.
Interventions
- Other Intervention Group: Gamma stimulation
Participants in this group be stimulated with gamma frequency (39-42 Hz). The frequency of the intervention will be 5 times a week, with the AVNS being used twice a week for 20 minutes (a minimum of 20 sessions - 8 to 12 weeks) and the other 3 days being spent at home with 20 minutes of audio frequency stimulation. - Other Control Group: Theta stimulation
Participants in this group will be stimulated with theta frequency (4-7 Hz). The frequency of the intervention will be 5 times a week, with the AVNS being used twice a week for 20 minutes (a minimum of 20 sessions - 8 to 12 weeks) and the other 3 days being spent at home with 20 minutes of audio frequency stimulation.
Primary outcome measures
- Cognitive screening [Time frame: From enrollment to the end of intervention]
- Performance of the dual motor-cognitive task [Time frame: From enrollment to the end of intervention]
- Blood biomarkers for chronic inflammatory conditions [Time frame: From enrollment to the end of intervention]
Secondary outcome measures (1)
- Depressive symptoms [Time frame: From enrollment to the end of intervention]
Eligibility criteria
Inclusion criteria
- Know how to read and write
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Portugal · 1 center
- Cooperativa Ensino Superior Politécnico e Universitário — Gandra
Publications
- Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270- PMID 21514249
- Singh-Manoux A, Kivimaki M, Glymour MM, Elbaz A, Berr C, Ebmeier KP, Ferrie JE, Dugravot A. Timing of onset of cognitive decline: results from Whitehall II prospective cohort study. BMJ. 2012 Jan 5;344:d7622. doi: 10.1136/bmj.d7622. PMID 22223828
- Ramos LR, Simoes EJ, Albert MS. Dependence in activities of daily living and cognitive impairment strongly predicted mortality in older urban residents in Brazil: a 2-year follow-up. J Am Geriatr Soc. 2001 Sep;49(9):1168-75. doi: 10.1046/j.1532-5415.2001.49233.x. PMID 11559375
- Yesavage JA, O'Hara R, Kraemer H, Noda A, Taylor JL, Ferris S, Gely-Nargeot MC, Rosen A, Friedman L, Sheikh J, Derouesne C. Modeling the prevalence and incidence of Alzheimer's disease and mild cognitive impairment. J Psychiatr Res. 2002 Sep-Oct;36(5):281-6. doi: 10.1016/s0022-3956(02)00020-1. PMID 12127595
- Morris JC, Storandt M, Miller JP, McKeel DW, Price JL, Rubin EH, Berg L. Mild cognitive impairment represents early-stage Alzheimer disease. Arch Neurol. 2001 Mar;58(3):397-405. doi: 10.1001/archneur.58.3.397. PMID 11255443
- Franceschi C, Garagnani P, Parini P, Giuliani C, Santoro A. Inflammaging: a new immune-metabolic viewpoint for age-related diseases. Nat Rev Endocrinol. 2018 Oct;14(10):576-590. doi: 10.1038/s41574-018-0059-4. PMID 30046148
- Krogh J, Benros ME, Jorgensen MB, Vesterager L, Elfving B, Nordentoft M. The association between depressive symptoms, cognitive function, and inflammation in major depression. Brain Behav Immun. 2014 Jan;35:70-6. doi: 10.1016/j.bbi.2013.08.014. Epub 2013 Sep 7. PMID 24016864
- Borges SM, Radanovic M, Forlenza OV. Correlation between functional mobility and cognitive performance in older adults with cognitive impairment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2018 Jan;25(1):23-32. doi: 10.1080/13825585.2016.1258035. Epub 2016 Dec 9. PMID 27934540
Identifiers
NCT: NCT06686563 · WAVE_56/CE-IPSN/2023