Effect of Transcranial NIR Light Upon Memory
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

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.
    

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.
    

Intervention name(s): NIR Transcranial phototherapy device; Placebo Transcranial Device
Intervention type(s): Device; Device
Intervention description(s): 1068 nm NIR helmet; The placebo device looks like the active device.
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)
Primary purpose: Treatment
Keywords: ageing; photobiomodulation; transcranial