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Mild Cognitive ImpairmentNCT06686563

WAVE: AudioVisual Stimulation Enhances Cognitive, Mental and Physical Health in Elderly

A study testing Intervention Group: Gamma stimulation in people with Mild Cognitive Impairment, run by Maria Paço at 1 site in Portugal.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Intervention Group: Gamma stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 sitePortugal
Study dates
Nov 2024to Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Know how to read and write

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Portugal1 site

  • Cooperativa Ensino Superior Politécnico e Universitário

    Gandra, Paredes, 4585-116

Other trials in Portugal

About this study

Official title: Audiovisual Stimulation in Elderly (Older Adults?): Effects on Cognition, Depressive Symptoms, and Dual Motor-Cognitive Tasks - a RCT

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.

Read the 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.

Being tested
Intervention Group: Gamma stimulation, Control Group: Theta stimulation
Keywords
Cognitive decline, Depressive symptoms, Audiovisual stimulation, Inflammaging, Older adults
Medical subject headings
Cognitive Dysfunction, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention Group: Gamma stimulationOther

    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.

  • Control Group: Theta stimulationOther

    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.

Study groups in NCT06686563
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants in the IG will 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. The participants will be assessed (regarding the outcomes previously described) at the baseline and reassessed after 3 months.
Receives: Other: Intervention Group: Gamma stimulation
Control GroupActive comparatorParticipants in the CG 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. The participants will be assessed (regarding the outcomes previously described) at the baseline and reassessed after 3 months.
Receives: Other: Control Group: Theta stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive screening

    Montreal Cognitive Assessment (MoCA)

    Measured: From enrollment to the end of intervention

  2. Performance of the dual motor-cognitive task

    Timed Up and Go (TUG)

    Measured: From enrollment to the end of intervention

  3. Blood biomarkers for chronic inflammatory conditions

    Measured: From enrollment to the end of intervention

Secondary outcomes (1)

  1. Depressive symptoms

    Geriatric Depressive Scale 15 items (GDS-15)

    Measured: From enrollment to the end of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study startNov 2024 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind randomized controlled clinical trial will be conducted with 48 elderly volunteers from a daycare center in Famalicão. After an initial cognitive screening (MoCA), assessment of depressive symptoms (GDS-15), agility and functional balance (TUG), and chronic inflammatory conditions (blood analysis), participants will be randomly assigned to a group (IG: intervention group; CG: control group). Participants in the CG will be stimulated with theta frequency (4-7 Hz), while participants in the IG will be stimulated with gamma frequency (39-42 Hz). For both groups, 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 at the appropriate frequency (GC: theta, GI: gamma). After this period, all participants will be re-evaluated.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686563
Sponsor's protocol ID
WAVE_56/CE-IPSN/2023
Status last verified
Nov 2024
First submitted
17 Jul 2024
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27934540

  • Tang HY, Riegel B, McCurry SM, Vitiello MV. Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Appl Psychophysiol Biofeedback. 2016 Mar;41(1):39-46. doi: 10.1007/s10484-015-9308-7.

    PubMed 26294268

  • Tang HY, Vitiello MV, Perlis M, Mao JJ, Riegel B. A pilot study of audio-visual stimulation as a self-care treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 2014 Dec;39(3-4):219-25. doi: 10.1007/s10484-014-9263-8.

    PubMed 25257144

  • Derner M, Chaieb L, Surges R, Staresina BP, Fell J. Modulation of Item and Source Memory by Auditory Beat Stimulation: A Pilot Study With Intracranial EEG. Front Hum Neurosci. 2018 Dec 11;12:500. doi: 10.3389/fnhum.2018.00500. eCollection 2018.

    PubMed 30618681

  • Chaieb L, Wilpert EC, Hoppe C, Axmacher N, Fell J. The Impact of Monaural Beat Stimulation on Anxiety and Cognition. Front Hum Neurosci. 2017 May 15;11:251. doi: 10.3389/fnhum.2017.00251. eCollection 2017.

    PubMed 28555100

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group: Gamma stimulation in people with Mild Cognitive Impairment, run by Maria Paço at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive screening (time frame: From enrollment to the end of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06686563, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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