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Transcranial Photobiomodulation Intervention for Healthy Older Adults

Effects of Transcranial Photobiomodulation Intervention on Working Memory and Functional Brain Networks for Healthy Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04608370
Enrollment
60
Registered
2020-10-29
Start date
2019-05-01
Completion date
2020-05-01
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Near-infrared Spectroscopy, Healthy Older Adults, Intervention, Transcranial Photobiomodulation, Working Memory

Keywords

Intervention, Neuroimaging, Working memory

Brief summary

Transcranial photobiomodulation (tPBM) is a novel, non-invasive neurostimulation technique, which has shown compelling potential for cognitive improvement. Increasing neuroimaging studies have demonstrated that functional brain network models would sensitively and comprehensively delineate action mechanisms of multiple neurostimulation techniques. However, the action mechanism of tPBM based on functional brain network remain largely unknown. In this project, the investigators aim to investigate the effectiveness of tPBM on working memory for healthy older adults. Taking the randomized, single-blind controlled method, participants in the active tPBM group will take active tPBM, and those in the sham tPBM group will take sham tPBM. After that, the investigators will investigate the changes of working. Furthermore, based on the neuroimaging technique, the regulatory mechanism of tPBM in intervening older adults will be revealed from the perspective of altered brain functional networks. This study will provide evidence for understanding whether the tPBM has the potentially therapeutic effect on cognitive function for healthy older adults as a non-drug treatment, and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Detailed description

An astonishing rise in the prevalence of cognitive decline and dementia in older adults was witnessed in recent years, which renders investigations of cognitive intervention especially urgent and vital. Transcranial photobiomodulation (tPBM) is now considered as a potentially non-pharmacologic intervention for cognitive decline and has attracted the interest of researchers. However, there are few existing studies involving the mechanism of tPBM on brain functional networks. Sixty healthy older participants will be recruited in this randomized, single-blind controlled trial. Each group had thirty participants.Participants in the active tPBM group will take active tPBM and those in the sham tPBM group will take sham tPBM. After that, the investigators will investigate the changes of working memory, which is the primary outcome. Furthermore, based on the neuroimaging technique of functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of tPBM in intervening older adults will be revealed from the perspective of altered brain functional networks. This study will provide evidence for understanding whether the tPBM has the potentially therapeutic effect on cognitive function for healthy older adults as a non-drug treatment, and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Interventions

BEHAVIORALActive tPBM session

In this project, taking the method of random, double blindness and control, participants in the active tPBM group will take active tPBM session. After that, N-back tests and neuroimaging biomarkers will be compared between active tPBM group and sham tPBM group.

BEHAVIORALSham tPBM session

In this project, taking the method of random, double blindness and control, participants in the sham tPBM group will take sham tPBM session. After that, N-back tests and neuroimaging biomarkers will be compared between active tPBM group and sham tPBM group.

Sponsors

Beijing Normal University
CollaboratorOTHER
XuanwuH 2
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

* 50-79 years old, right-handed and Mandarin-speaking subjects; * Normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests

Exclusion criteria

* Current diagnosis with mild cognitive decline or dementia; * Current major psychiatric diagnoses such as severe depression and anxiety; * Other neurological conditions (e.g., cerebrovascular disease, brain tumors, Parkinson's disease, encephalitis, or epilepsy) * Other diseases which could cause cognitive decline (e.g., thyroid dysfunction, severe anemia, syphilis, or HIV)

Design outcomes

Primary

MeasureTime frameDescription
Working memory24 hoursN-back task is one of the most classic cognitive to study working memory (Bopp and Verhaeghen, 2020). During this task, participants are asked to decide if a digit appearing on a screen is the same as the digit that appeared n stimuli earlier (n-back). Working memory load varies with n between blocks. In our study, the digit (0 to 9) was randomly presented on a screen for 1 seconds every 2 seconds and a total of 20 digit formed one trial. The whole task consists of three blocks, and each of block includes 3 trials -sequentially 1-back, 2-back, 3-back. The presentation of n-back were generated by E-Prime 3. Mean accuracy and reaction time for correct trials are used as n-back performance indicators.

Secondary

MeasureTime frameDescription
FNIRS-based brain functional networks changes24 hoursThe brain functional activity data will be collected using functional near-infrared spectroscopy (fNIRS) technique. The investigators will compare the changes of brain functional networks based on the measure of oxyhemoglobin concentration signal with relatively high signal to noise ratio (SNR) in two groups, in order to reveal the regulatory mechanism of the tPBM in intervening older persons.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026