Clinical trial NCT04608370: Transcranial Photobiomodulation Intervention for Healthy Older Adults
Official title: Effects of Transcranial Photobiomodulation Intervention on Working Memory and Functional Brain Networks for Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Photobiomodulation
Intervention
Functional Near-infrared Spectroscopy
Working Memory
Healthy Older Adults
Keywords: Intervention
Neuroimaging
Working memory
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Normal University
First posted: 2020-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Working memory
timeFrame: 24 hours
Secondary outcomes:
measure: FNIRS-based brain functional networks changes
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurolgy, Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Ying Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: