Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 8:40 PM
Study NCT ID:
NCT04568057
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2020-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcranial NIR Light Upon Memory
Sponsor:
Maculume Ltd.
Organization:
Study Overview
Official Title:
Effect of Transcranial Near Infrared Light 1068 nm Upon Memory Performance in Ageing Healthy Individuals: a Pilot Study.
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: