Transcranial PhotobiomodulationNCT04608370
Transcranial Photobiomodulation Intervention for Healthy Older Adults
A study testing Active tPBM session in people with Transcranial Photobiomodulation and Intervention, run by XuanwuH 2 at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Photobiomodulation, Intervention, Functional Near-infrared Spectroscopy
- What is being tested?
- Active tPBM session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-79 years old, right-handed and Mandarin-speaking subjects;
- Normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Department of Neurolgy, Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
Official title: Effects of Transcranial Photobiomodulation Intervention on Working Memory and Functional Brain Networks for Healthy Older Adults
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.
Read the 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.
- Conditions
- Transcranial Photobiomodulation, Intervention, Functional Near-infrared Spectroscopy, Working Memory, Healthy Older Adults
- Being tested
- Active tPBM session, Sham tPBM session
- Keywords
- Intervention, Neuroimaging, Working memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tPBM sessionBehavioural
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 sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham tPBM session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 May 2019
- Primary completion1 Oct 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial PhotobiomodulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- XuanwuH 2
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University
- Responsible party
- Sponsor-investigator, XuanwuH 2, Xuanwu Hospital, Beijing
- Investigators
- Ying Han, PhD, Principal investigator, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608370
- Sponsor's protocol ID
- HanYingsc4
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information of neuropsychological tests will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Photobiomodulation Intervention on Working Memory and Functional Brain Networks for Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04608370
- Acronym / sponsor ID
- HanYingsc4
- Conditions
- Transcranial Photobiomodulation, Intervention, Functional Near-infrared Spectroscopy, Working Memory, Healthy Older Adults
- Keywords
- Intervention, Neuroimaging, Working memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- XuanwuH 2University, hospital or other
- Collaborators
- Beijing Normal University
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tPBM session group | Experimental | Behavioral: Active tPBM sessionParticipants 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. |
| Sham tPBM session group | Active comparator | Behavioral: Sham tPBM sessionParticipants 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. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50-79 years old, right-handed and Mandarin-speaking subjects;
- Normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tPBM sessionIn 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. | Behavioural | Active tPBM session group |
| Sham tPBM sessionIn 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. | Behavioural | Sham tPBM session group |
Primary outcome
Working memory
Time frame: 24 hours
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.
1 secondary outcome
FNIRS-based brain functional networks changes
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: Yes. The information of neuropsychological tests will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Han, PhD principal investigator
Xuanwu Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tPBM session in people with Transcranial Photobiomodulation and Intervention, run by XuanwuH 2 at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.