Transcranial Photobiomodulation Intervention for Healthy Older Adults

XuanwuH 2

Status: Completed

Conditions: Transcranial Photobiomodulation; Functional Near-infrared Spectroscopy; Working Memory; Intervention; Healthy Older Adults

Treatments: Behavioral: Sham tPBM session; Behavioral: Active tPBM session

Study type: Interventional

Funder types: Other

Identifiers

NCT04608370

HanYingsc4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 50 to 79 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Active tPBM session group

Experimental group

Description:

Participants in the active tPBM group will take active tPBM session, which include 12 minutes active tPBM by a 1064nm laser to the left forehead , 6 minutes resting-state fNIRS measurement, and 8 minutes digital n-back task-an ubiquitous cognitive task for working memory.

Treatment:

Behavioral: Active tPBM session

Sham tPBM session group

Active Comparator group

Description:

Participants in the sham tPBM group will take sham tPBM session, which include 12 minutes sham tPBM by a 1064nm laser to the left forehead , 6 minutes resting-state fNIRS measurement, and 8 minutes digital n-back task-an ubiquitous cognitive task for working memory.

Treatment:

Behavioral: Sham tPBM session