Photo Neuro-Modulation Therapy to Adults

Not Applicable

• Conditions: Photo Neuro-Modulation Therapy, Mild Cognitive Impairment
• Interventions: Other: Sham; Device: Photoneuromodulation therapy

• Registration Number: NCT04182529
• Lead Sponsor: Chinese University of Hong Kong

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-31
• Status Verified: 2019-11
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-29
• Last Update Submitted: 2019-11-29
• Study First Posted: 2019-12-02
• Last Update Posted: 2019-12-02
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sham	Subject will not be given any active stimulation
Photoneuromodulation Therapy	Photoneuromodulation therapy	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.

Primary Outcome Measures

Name	Time	Method
Category Fluency Test	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	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	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	through study completion, an average of 2 year	NIRS to record the hemodynamic response, measured in mmol/mm
EEG Recordings	through study completion, an average of 2 year	EEG source localisation, measured in current density
N-Back Test (cognitive test battery)	through study completion, an average of 2 year	a digit n-back paradigm to assess working memory

Trial Locations

Locations (1)

Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong