Transcranial Photobiomodulation Intervention for Healthy Older Adults

NCT04608370 | Completed

• 1 other identifier: HanYingsc4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intervention; Neuroimaging; Working memory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• FNIRS-based brain functional networks changes

  24 hours

Study Arms (2)

Active tPBM session group

EXPERIMENTAL

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.

Behavioral: Active tPBM session

Sham tPBM session group

ACTIVE COMPARATOR

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.

Behavioral: Sham tPBM session

Interventions

Active tPBM session BEHAVIORAL

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.

Active tPBM session group

Sham tPBM session BEHAVIORAL

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.

Sham tPBM session group

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• XuanwuH 2: lead
• Beijing Normal University: collaborator

Study Sites (1)

Department of Neurolgy, Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Study Officials

• Ying Han, PhD

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 29, 2020
• Study Start: May 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: When summary data are published or starting 6 months after publication
• Access Criteria: The information of neuropsychological tests data will be shared.

Locations

CN (1)