Photo Neuro-Modulation Therapy to Adults

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.

Study Overview

• Status: Unknown
• Conditions: Photo Neuro-Modulation Therapy, Mild Cognitive Impairment
• Intervention / Treatment: Device: Photoneuromodulation therapy; Other: Sham

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 29, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2017.354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No