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Effect of Transcranial NIR Light Upon Memory

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04568057
Recruitment Status : Completed
First Posted : September 29, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Maculume Ltd.

Study Description
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Brief Summary:
A double-blind placebo-controlled study evaluating the effect of 1068nm NIR trans-cranial phototherapy upon the cognitive function of healthy individuals between the age of 45 years and 80 years.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Device: NIR Transcranial phototherapy device Device: Placebo Transcranial Device Not Applicable

Detailed Description:

Interested participants will be sent a participant information bundle consisting of the participant information sheet, consent document, and data collection sheets. One week after receiving these documents, they will be contacted by a member of the research team to ascertain if they wish to participate. If the individual wishes to participate in the trial, an appointment at a mutually convenient time will be made for the volunteer to be seen. The initial screening interview will be conducted by a trained research assistant. At this appointment, the research assistant will explain the details of the trial and offer an opportunity for the volunteer to ask questions. The consent document will then be completed by the volunteer and countersigned by the researcher.

  1. The volunteer will have several days to decide whether they wish to participate in the trial as they will have received the information pack in the mail previously. The volunteer would have the option of speaking to the Investigator directly before enrolling.
  2. The volunteer will have an opportunity to ask questions and have any points of concern clarified.
  3. Informed consent will be obtained from the volunteer.
  4. The volunteer will be interviewed and a detailed history is taken. Baseline information regarding the volunteer's circumstance will be gathered, including confirming the MMSE score is >28 (a score of <28 is an exclusion criterion).
  5. The volunteer will be allocated a number and will we offered a choice of appointment times and will be seen on three separate occasions for assessment of their executive function and memory. Three tests are necessary to average the day-to-day variation present in cognitive functioning.
  6. Testing will be rescheduled if the volunteer has a minor intercurrent illness eg. Flu, minor viral infection.
  7. After the third ANAM assessment the volunteer will proceed to receive the intervention.
  8. Intervention procedure: Once allocated to either active or placebo group everyone will be given a trans-cranial intervention device to take home with them. They will be shown how to use the device, which should be used for 6 minutes twice daily every day of the week.
  9. Telephone contact will be made by a researcher with the participant every 2 weeks throughout the intervention period to make the following verbal observations:

a. has there been any change in the health of the participant? b. Are there any problems with the device? j. After 56 days of twice-daily intervention, the participant will be scheduled for re-assessment on three separate days. They will continue with the use of the NIR helmet device until the last assessment is completed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind placebo-controlled, one group received a placebo device and once group an active device.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

NIR light is invisible to the human eye, therefore the placebo units will operate in an identical manner to that of the active units.

The active and placebo helmets will look identical and their external operation will appear identical, each device will be marked with a code by the manufacturer, there will be no way to identify a device from active or placebo.
Primary Purpose: Treatment
Official Title: Effect of Transcranial Near Infrared Light 1068 nm Upon Memory Performance in Ageing Healthy Individuals: a Pilot Study.
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NIR Transcranial phototherapy device
The active transcranial phototherapy device. 1068 nm NIR Transcranial phototherapy PBM-T device An air-cooled LED helmet with a peak wavelength of 1068 nm, spectral width of 60 nm, and a 6-minute internal timer was used. The average optical power output of the combined arrays is circa 3.8 Watts, 12mw/sq. cm. The total energy to be delivered to the cranium is 1368J (3.8 x 360) per treatment session.
 Device: NIR Transcranial phototherapy device
1068 nm NIR helmet
Placebo Comparator: Placebo Device.
Placebo cranial device. The external appearance of the device is identical to that of the active device but no NIR light is emitted.
 Device: Placebo Transcranial Device
The placebo device looks like the active device.


Outcome Measures
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Primary Outcome Measures :
  1. Automated Neuropsychological Assessment Metrics [ Time Frame: 56 days ]
    Computerised neurophysiological assessment tool


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥45 years, ≤ 80 years
  • MMSE score >28 (out of 30)
  • No chronic illnesses other than hypertension, asthma, or mild COPD
  • Stable, controlled chronic illness e.g. hypertension, asthma, COPD

Exclusion Criteria:

  • Diagnosed actively growing intracranial pathology (tumors etc.)
  • Mental health illness
  • Misuse of illegal substances or alcohol
  • Use of regular systemic steroids or cancer drugs
  • Cancers that affect your body
  • Not fluent in English
  • Depressed, or feeling depressed.
  • Epilepsy
  • Lacking capacity to give informed consent
  • Previous history of stroke
  • History of aggression or violence
  • Inability to attend the research venue for assessment
  • Assessed as probably being non-complaint with the intervention regime
  • Diabetes
  • Diagnosed with a neurological condition eg. Parkinson's disease, multiple sclerosis
  • Diagnosed with dementia of any cause
  • Chronic pain disorders
  • Volunteers taking medication which would impair cognitive function such as gabapentin, pregabalin, strong opiates (e.g. morphine)
  • Any chronic illness other than hypertension, asthma, or mild COPD.
  • Not being available for all the assessment sessions.
  • Participants currently involved in any other research program
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04568057


Locations
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United Kingdom
Maculume Ltd
Spennymoor, Durham, United Kingdom, DL16 6TR
Sponsors and Collaborators
Maculume Ltd.
Investigators
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Principal Investigator: Gordon Dougal, MB ChB Maculume Ltd.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maculume Ltd.
ClinicalTrials.gov Identifier: NCT04568057    
Other Study ID Numbers: M20Q004
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maculume Ltd.:
ageing
photobiomodulation
transcranial
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders