Photo Neuro-Modulation Therapy to Adults

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT04182529
Collaborator
(none)
40
1
2
32
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Photoneuromodulation therapy
  • Other: Sham
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Photo Neuro-Modulation Therapy to Middle Aged and Older Adults With Mild Memory Problem
Actual Study Start Date :
Oct 31, 2017
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. N-Back Test (cognitive test battery) [through study completion, an average of 2 year]

    a digit n-back paradigm to assess working memory

  2. 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

  3. The Hong Kong List Learning Test [through study completion, an average of 2 year]

    a tests to assess memory function of the participants

  4. 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

  5. NIRS Recording [through study completion, an average of 2 year]

    NIRS to record the hemodynamic response, measured in mmol/mm

  6. EEG Recordings [through study completion, an average of 2 year]

    EEG is used to record electrical activity of the brain, measured in microvolts, EEG power spectrum

  7. EEG Recordings [through study completion, an average of 2 year]

    EEG source localisation, measured in current density

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Chan Sui-yin Agnes, Professor Chan Sui-yin Agnes, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04182529
Other Study ID Numbers:
  • 2017.354
First Posted:
Dec 2, 2019
Last Update Posted:
Dec 2, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2019