Photo Neuro-Modulation Therapy to Adults

NCT04182529 | Unknown

• 1 other identifier: 2017.354
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Photo Neuro-Modulation Therapy, Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

Device: Photoneuromodulation therapy

Control Group

SHAM COMPARATOR

Subject will not be given any active stimulation

Other: Sham

Interventions

Photoneuromodulation therapy DEVICE

low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800

Photoneuromodulation Therapy

Sham OTHER

Sham, no active stimulation will be given to subjects

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• middle age and older adults with aged 40 or above who have subjective memory complaints

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chan Sui-yin Agnes

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 2, 2019
• Study Start: October 31, 2017
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

HK (1)