Photo Neuro-Modulation Therapy to Adults

Study Overview
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Brief Summary
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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.

Official Title
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Photo Neuro-Modulation Therapy to Middle Aged and Older Adults With Mild Memory Problem

Conditions
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Photo Neuro-Modulation Therapy, Mild Cognitive Impairment

Intervention / Treatment
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* Device: Photoneuromodulation therapy
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 middle age and older adults with aged 40 or above who have subjective memory complaints Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photoneuromodulation Therapy<br>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. | Device: Photoneuromodulation therapy<br>* low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800<br>|
| Sham Comparator: Control Group<br>Subject will not be given any active stimulation | Other: Sham<br>* Sham, no active stimulation will be given to subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-Back Test (cognitive test battery) | a digit n-back paradigm to assess working memory | 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 | through study completion, an average of 2 year | 
| The Hong Kong List Learning Test | a tests to assess memory function of the participants | 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 | through study completion, an average of 2 year | 
| NIRS Recording | NIRS to record the hemodynamic response, measured in mmol/mm | 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 | through study completion, an average of 2 year | 
| EEG Recordings | EEG source localisation, measured in current density | through study completion, an average of 2 year |