Participant Information Sheet
Does trans-cranial phototherapy with NIR light improve cognitive function in healthy individuals aged between 45 and 90 years of age?
The purpose of this study is to assess the effect of Near Infrared (NIR) trans-cranial phototherapy on age related intellectual impairment.
There are two main components to the research, the assessment component and the intervention component.
An assessment will be conducted both before and after the intervention component and is an independent way of checking to see if the intervention works.
The intervention will be carried out by your self. A trained assistant will demonstrate to you how to use the NIR applicator. The NIR applicator will be applied twice daily for an 28 days period. The application time will be 6 minutes on each occasion.
The assessment is carried out in your home or any other venue convenient to you.
Does trans-cranial phototherapy with NIR light improve cognitive function in healthy individuals aged between 45 and 90 years of age.
We would like to invite you to take part in a study. Before you decide you need to understand why the study is being done and what it would involve for you.
Please take time to read the following information carefully. Talk to others about the study if you wish.
(Part 1 tells you the purpose of this study and what will happen to you if you take part.
Part 2 gives you more detailed information about the conduct of the study).
Please ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
The main reason for doing the study is to see if the application of NIR using a trans-cranial light applicator twice daily will improve cognitive function that has declined due to age-related intellectual impairment.
You may take part in this study if you are:
· Between 40 and 90 years of age
· If you have high blood pressure, asthma or mild COPD, these must be stable and controlled.
It is up to you to decide if you want to take part. We will describe the study and go through this information sheet, which we will then give to you. We will then ask you to sign a consent form to show you have agreed to take part. You are free to withdraw at any time, without giving a reason.
If you decide to take part in this trial, the trial will last 28 days, the total period of involvement will be 35 days including the period of testing.
At the initial meeting you will be asked questions to obtain a history of your health and an assessment of your memory and intellectual function will be conducted. You will be given the opportunity to ask questions and any issues will be clarified. This will be carried out by an investigator. This is important; as we need to make sure you are eligible to take part in the study.
If the preliminary assessment identifies that you can take part in the trial then you will be offered a choice of appointments on three separate occasions in order to assess your memory and intellectual function. Tests on three separate occasions are required in order to determine average day-to-day variation present in performance of intellectual tasks.
The assessment includes 2 separate tests (total time taken: 45 minutes):
1. Stroop test; this involves reading out loud the names of colours, 100 to a page; this is followed by naming a 100 different coloured rectangles on a page; the final page has the names of colours printed on a page, but the colour of the words is not the same as the name of the colour, you will be asked to say the colour of the writing, not what the word says. You will be timed to see how long it take you to read out each of the pages.
- Automated Neuropsychological Assessment Metrics (computer based test)
Appointments will be rescheduled if you are suffering from a minor illness such as a cold.
After the 1st appointment you will be allocated a number, which will be used to place you either in the dummy or active group.
Once you have completed the assessment a trained assistant will demonstrate to you how to use the trans-cranial applicator. The intervention is non-invasive and the invisible infrared light is of low power and has no heating associated with the intervention and will not harm your eyes.
You will be contacted every 2 weeks by telephone to ascertain if you are having issues that are of concern and to check that you are managing to do the applications as requested.
After 28 days of twice daily application the intervention will be stopped. A follow up of 3 separate assessments will then take place 2-7 days after intervention has ceased.
If you are on any medication we ask that you tell us, and we will keep a record of this medication. It is important that you continue taking all your medication as normal.
No personal information will be published without your expressed written permission.
The trial is a double blind randomised controlled trial. There are explanations below which will help you understand what this means.
Sometimes we don’t know which intervention is best. To find out, we need to compare different interventions. We put people into groups and give each group a different intervention. The results are compared to see if one is better. To try to make sure the groups are the same to start with, each participant is put into a group by chance (randomly).
In this trial you will have a 1 in 2 chance of getting the active device.
In a ‘blind trial’ you will not know which group you are in. If the trial is a ‘double blind trial’, neither you nor the investigators will know in which group you are (although, if you need to find out this can be done).
In this particular study we are testing to see if the Near infra-red helmet has a restorative effect upon intellectual function and memory. To do this half the devices supplied will be “dummy devices” which appear the same as the real thing except they do not emit any light. As mentioned previously, there is a 1 in 2 chance of getting a dummy device.
Travel expenses between your place of residence and the study centre will be refunded, up to a maximum of £10.00 per visit.
What will I have to do?
You will need to be available to take part in the assessments, 7 in total, each taking approximately 60 minutes each.
You will need use the trans-cranial applicator on yourself twice daily for 84 days, 6 minutes on each occasion.
You will need to continue with any of your medication as normal.
The device being tested is a trans-cranial light applicator. It is a new approach to reducing the impact of age-related intellectual impairment and involves the use of low power infrared light applied to the cranium. Utilization of infrared light via the trans-cranial route is used currently to monitor intercranial oxygenation; approximately 10% of the incident light (on the skin) penetrates through to reach the surface of the Brain.
The Trans-cranial light applicator (Cerebrolite)
We will ask you to sign a standard hire document commonly used when people take expensive equipment home with them.
We will ask you to sign this type of agreement when taking the Cerebrolite home with you.
In the event the Cerebrolite malfunctions or breaks we will not hold you responsible; we do however request that you let us know as soon as this happens so it can be replaced.
As with any piece of equipment we do ask that you keep it in a safe and secure environment.
In the event that it is stolen, we would ask that the police be informed to enable us to make an insurance claim.
Please let us know if any of the above occurs so we can replace the Cerebrolite in a timely manner.
Possible Disadvantages to taking part
This technology is not proven to be beneficial.
NIR light has no known interactions with any medication and exposure to this particular wavelength and intensity of NIR light has not been known to adversely affect any insurance issues.
The light sources in the NIR trans-cranial applicator have been tested and approved for their intended use by a notified body. The Applicator is CE approved for the intended use.
Potential Side Effects
There have been no documented side effects to the use of low power NIR light. Very rarely some individuals may have an allergy to the plastic with which the Cerebrolite is constructed. If this occurs you will be withdrawn from the study.
Possible benefits of taking part
We cannot promise the study will help you but the information we get from this study may help improve the management of people with age-related intellectual impairment.
When the Study stops
At the conclusion of the study, if the outcome is positive, the Cerebrolite will be available commercially.
What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information on this is given in Part 2.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.
This completes part 1
If the information in Part 1 has interested you and you are considering participation, please read the additional information in Part 2 before making any decision.
Part 2 of the information sheet
What if relevant new information becomes available?
Sometimes we get new information about the device being studied. If this happens, your study investigator will tell you and discuss whether you should continue in the study. If you decide not to carry on with the study we would ask you to let us know and return the Cerebrolite to us.
If you decide to continue in the study he may ask you to sign an updated consent form.
If the study is stopped for any other reason, we will tell you and explain the reason why.
What will happen if I do not want to carry on with the study?
Data that we have already collected will be kept and if you wish we can arrange to have you assessed prior to leaving the study. This will only be carried out if you are completely happy to have this assessment.
If you have a concern about any aspect of this study, you should ask to speak to the studyers who will do their best to answer your questions, Dr Berman, PhD, phone number: 01388 812 571. If you remain unhappy and wish to complain formally, you can do this to Maculume Ltd,9 Castle Close, Spennymoor
County Durham, DL16 6TR
In the event that something does go wrong and you are harmed during the study and this is due to someone’s negligence then you may have grounds for a legal action for compensation against Maculume Limited, but you may have to pay your legal costs.
Will my taking part in the study be kept confidential?
If you join the study, the data collected will be looked at by authorized persons from Maculume Ltd. Authorised representatives of regulatory authorities may also look at this data to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a study participant and we will do our best to meet this duty.
You will be able to examine any information that is recorded related to your participation in the trial if you request it.
All information on your participation in the trial and any information collected will be kept in a locked cupboard. Any electronic data will be stored on a CD, which will be kept in a locked cupboard. No information will be stored on memory sticks or laptops.
At the end of the trial your data will be used to ascertain if the intervention has worked. No identifiable information about you will be made public without your expressed written permission.
The only individuals that will have access to the data collected about you will be the investigators who are carrying out the study and those people who analyze the results.
We would like to notify your General Practitioner of your involvement in this study and in that regards we will give you a letter to hand in at your GP surgery.
What happens to the results of the study?
You will be informed what type of device you received at the end of the study (ie. Active or dummy device).
Any incidental information that is noted during the trial will be passed on to the participants when they are notified which arm of the trial they were allocated.
The results of the study will be published in a journal.
Maculcume Ltd is funding and organising this study.
For further information please contact:
Dr Berman, PhD, email: firstname.lastname@example.org
In the event there are any issues whatsoever please contact Dr Berman, PhD directly.
You will be given a copy of this information sheet to keep and you will be given a copy of the signed Consent Document to keep.