Photo Neuro-Modulation Therapy, Mild Cognitive ImpairmentNCT04182529
Photo Neuro-Modulation Therapy to Adults
A study testing Photoneuromodulation therapy in people with Photo Neuro-Modulation Therapy, Mild Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
It is well-documented that mild cognitive impairment (MCI) is associated frontal lobe dysfunction and executive dysfunction. In addition, many studies reported high level of MCI symptoms among the elderly and the trend is increasing in Hong Kong. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Photo Neuro-Modulation Therapy, Mild Cognitive Impairment
- What is being tested?
- Photoneuromodulation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Oct 2017to Jul 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 middle age and older adults with aged 40 or above who have subjective memory complaints
Who cannot join
- A history of head injury, or any neurological/psychiatric disorders, and dementia will be excluded. In addition, a score higher than 7 on the short form of the Chinese Geriatric Depression Scale (CGDS-SF; Lee, Chiu, Kwok, \& Leung, 1993)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
Hong Kong
Sui-yin Agnes Chan, PhD, +85239434166, aschan@cuhk.edu.hk
About this study
Official title: Photo Neuro-Modulation Therapy to Middle Aged and Older Adults With Mild Memory Problem
It is well-documented that mild cognitive impairment (MCI) is associated frontal lobe dysfunction and executive dysfunction. In addition, many studies reported high level of MCI symptoms among the elderly and the trend is increasing in Hong Kong. Based upon the link between MCI and frontal and executive function problems, it is conceivable that elderly who exhibits high levels of memory problems would exhibit frontal and executive function problems. To our knowledge, there is still a lack of effective treatment or therapy for MCI, it is important to investigate effective intervention that can efficiently improve the cognitive ability of MCI patients or patients with mild memory problems. The objective of the present study is to compare individuals with mild memory problems after the Photo neuro-modulation Therapy (PNMT) and those who do not. 40 middle aged and older adults were recruited from the subject database of the Neuropsychology Laboratory of The Chinese University of Hong Kong. Participants were divided randomly and equally into treatment group, as well as the placebo group. Several computerized executive function tests will be used before and after the treatment under the recording of near-infrared spectroscopy (NIRS), which estimates level of frontal activation. It is hypothesized that compared to participants without PNMT, those with PNMT will have a better performance in the executive function tasks and exhibit a higher frontal activation. The cognitive and neurophysiological results would provide evidences on the possibility of PNMT in treating individuals with mild memory problems, as well as with other mental disorders.
- Being tested
- Photoneuromodulation therapy, Sham
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoneuromodulation therapyDevice
low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800
ShamOther
Sham, no active stimulation will be given to subjects
| Study group | Role | What they receive |
|---|---|---|
| Photoneuromodulation Therapy | Experimental | In this study low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800 will be used. The United States Food and Drug Administration (FDA) has approved this type of device as imposing insignificant risk (FDA-cleared for home treatment, 2005). At each visit, LED clusters will be applied simultaneously for 20 minutes on the Fp1, Fp2 and Pz regions according to the International 10-20 system (Homan, Herman and Purdy, 1987) (energy density, 13 Joules/cm2 [J/cm2] per each LED cluster head placement). The total LED treatment time per visit was 20 minutes. Receives: Device: Photoneuromodulation therapy |
| Control Group | Sham comparator | Subject will not be given any active stimulation Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-Back Test (cognitive test battery)
a digit n-back paradigm to assess working memory
Measured: through study completion, an average of 2 year
Category Fluency Test
a test to assess the ability to generate words that belong to a semantic category in a controlled manner
Measured: through study completion, an average of 2 year
The Hong Kong List Learning Test
a tests to assess memory function of the participants
Measured: through study completion, an average of 2 year
The Chinese Version of the Mattis Dementia Rating Scale
a test to estimate the global functioning level of the participants, lowest score is 0, highest score is 144, higher score means better global functioning level
Measured: through study completion, an average of 2 year
NIRS Recording
NIRS to record the hemodynamic response, measured in mmol/mm
Measured: through study completion, an average of 2 year
EEG Recordings
EEG is used to record electrical activity of the brain, measured in microvolts, EEG power spectrum
Measured: through study completion, an average of 2 year
EEG Recordings
EEG source localisation, measured in current density
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start31 Oct 2017
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photo Neuro-Modulation Therapy, Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Chan Sui-yin Agnes, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182529
- Sponsor's protocol ID
- 2017.354
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photo Neuro-Modulation Therapy to Middle Aged and Older Adults With Mild Memory Problem
- ClinicalTrials.gov ID
- NCT04182529
- Acronym / sponsor ID
- 2017.354
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 2 Dec 2019 (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.
It is well-documented that mild cognitive impairment (MCI) is associated frontal lobe dysfunction and executive dysfunction. In addition, many studies reported high level of MCI symptoms among the elderly and the trend is increasing in Hong Kong. Based upon the link between MCI and frontal and executive function problems, it is conceivable that elderly who exhibits high levels of memory problems would exhibit frontal and executive function problems. To our knowledge, there is still a lack of effective treatment or therapy for MCI, it is important to investigate effective intervention that can efficiently improve the cognitive ability of MCI patients or patients with mild memory problems. The objective of the present study is to compare individuals with mild memory problems after the Photo neuro-modulation Therapy (PNMT) and those who do not. 40 middle aged and older adults were recruited from the subject database of the Neuropsychology Laboratory of The Chinese University of Hong Kong. Participants were divided randomly and equally into treatment group, as well as the placebo group. Several computerized executive function tests will be used before and after the treatment under the recording of near-infrared spectroscopy (NIRS), which estimates level of frontal activation. It is hypothesized that compared to participants without PNMT, those with PNMT will have a better performance in the executive function tasks and exhibit a higher frontal activation. The cognitive and neurophysiological results would provide evidences on the possibility of PNMT in treating individuals with mild memory problems, as well as with other mental disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photoneuromodulation Therapy | Experimental | Device: Photoneuromodulation therapyIn this study low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800 will be used. The United States Food and Drug Administration (FDA) has approved this type of device as imposing insignificant risk (FDA-cleared for home treatment, 2005). At each visit, LED clusters will be applied simultaneously for 20 minutes on the Fp1, Fp2 and Pz regions according to the International 10-20 system (Homan, Herman and Purdy, 1987) (energy density, 13 Joules/cm2 [J/cm2] per each LED cluster head placement). The total LED treatment time per visit was 20 minutes. |
| Control Group | Sham comparator | Other: ShamSubject will not be given any active stimulation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40 middle age and older adults with aged 40 or above who have subjective memory complaints
Key exclusion criteria (1 listed)
- A history of head injury, or any neurological/psychiatric disorders, and dementia will be excluded. In addition, a score higher than 7 on the short form of the Chinese Geriatric Depression Scale (CGDS-SF; Lee, Chiu, Kwok, \& Leung, 1993)
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 |
|---|---|---|
| Photoneuromodulation therapylow-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800 | Device | Photoneuromodulation Therapy |
| ShamSham, no active stimulation will be given to subjects | Other | Control Group |
Primary outcome
N-Back Test (cognitive test battery)
Time frame: through study completion, an average of 2 year
a digit n-back paradigm to assess working memory
Category Fluency Test
Time frame: through study completion, an average of 2 year
a test to assess the ability to generate words that belong to a semantic category in a controlled manner
The Hong Kong List Learning Test
Time frame: through study completion, an average of 2 year
a tests to assess memory function of the participants
The Chinese Version of the Mattis Dementia Rating Scale
Time frame: through study completion, an average of 2 year
a test to estimate the global functioning level of the participants, lowest score is 0, highest score is 144, higher score means better global functioning level
NIRS Recording
Time frame: through study completion, an average of 2 year
NIRS to record the hemodynamic response, measured in mmol/mm
EEG Recordings
Time frame: through study completion, an average of 2 year
EEG is used to record electrical activity of the brain, measured in microvolts, EEG power spectrum
EEG Recordings
Time frame: through study completion, an average of 2 year
EEG source localisation, measured in current density
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: Undecided
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.
Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
Hong Kong, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoneuromodulation therapy in people with Photo Neuro-Modulation Therapy, Mild Cognitive Impairment, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2019. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-Back Test (cognitive test battery) (time frame: through study completion, an average of 2 year). The study lists 7 primary outcomes in all. 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 2 Dec 2019.