Transcranial Photobiomodulation Intervention for Healthy Older Adults

Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608370
• Other study ID #: HanYingsc4
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: October 2020
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Active 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.
• Sham 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.

Locations

Country	Name	City	State
China	Department of Neurolgy, Xuanwu Hospital of Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
XuanwuH 2	Beijing Normal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working memory	N-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.	24 hours
Secondary	FNIRS-based brain functional networks changes	The 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.	24 hours