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Photo Neuro-Modulation Therapy to Adults

Primary Purpose

Photo Neuro-Modulation Therapy, Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Photoneuromodulation therapy
Sham
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photo Neuro-Modulation Therapy, Mild Cognitive Impairment

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Photoneuromodulation Therapy

Control Group

Arm Description

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.

Subject will not be given any active stimulation

Outcomes

Primary Outcome Measures

N-Back Test (cognitive test battery)
a digit n-back paradigm to assess working memory
Category Fluency Test
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
a tests to assess memory function of the participants
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
NIRS Recording
NIRS to record the hemodynamic response, measured in mmol/mm
EEG Recordings
EEG is used to record electrical activity of the brain, measured in microvolts, EEG power spectrum
EEG Recordings
EEG source localisation, measured in current density

Secondary Outcome Measures

Full Information

First Posted
November 22, 2019
Last Updated
November 29, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04182529
Brief Title
Photo Neuro-Modulation Therapy to Adults
Official Title
Photo Neuro-Modulation Therapy to Middle Aged and Older Adults With Mild Memory Problem
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photo Neuro-Modulation Therapy, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photoneuromodulation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Subject will not be given any active stimulation
Intervention Type
Device
Intervention Name(s)
Photoneuromodulation therapy
Intervention Description
low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham, no active stimulation will be given to subjects
Primary Outcome Measure Information:
Title
N-Back Test (cognitive test battery)
Description
a digit n-back paradigm to assess working memory
Time Frame
through study completion, an average of 2 year
Title
Category Fluency Test
Description
a test to assess the ability to generate words that belong to a semantic category in a controlled manner
Time Frame
through study completion, an average of 2 year
Title
The Hong Kong List Learning Test
Description
a tests to assess memory function of the participants
Time Frame
through study completion, an average of 2 year
Title
The Chinese Version of the Mattis Dementia Rating Scale
Description
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
Time Frame
through study completion, an average of 2 year
Title
NIRS Recording
Description
NIRS to record the hemodynamic response, measured in mmol/mm
Time Frame
through study completion, an average of 2 year
Title
EEG Recordings
Description
EEG is used to record electrical activity of the brain, measured in microvolts, EEG power spectrum
Time Frame
through study completion, an average of 2 year
Title
EEG Recordings
Description
EEG source localisation, measured in current density
Time Frame
through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sui-yin Agnes Chan, PhD
Phone
+85239434166
Email
aschan@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Photo Neuro-Modulation Therapy to Adults

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