Age-related Cognitive DeclineNCT04568057
Effect of Transcranial NIR Light Upon Memory
A study testing NIR Transcranial phototherapy device in people with Age-related Cognitive Decline, run by Maculume Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- NIR Transcranial phototherapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcranial Near Infrared Light 1068 nm Upon Memory Performance in Ageing Healthy Individuals: a Pilot Study.
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.
Read the 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.
- 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.
- The volunteer will have an opportunity to ask questions and have any points of concern clarified.
- Informed consent will be obtained from the volunteer.
- 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).
- 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.
- Testing will be rescheduled if the volunteer has a minor intercurrent illness eg. Flu, minor viral infection.
- After the third ANAM assessment the volunteer will proceed to receive the intervention.
- 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.
- Telephone contact will be made by a researcher with the participant every 2 weeks throughout the intervention period to make the following verbal observations:
- 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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- NIR Transcranial phototherapy device, Placebo Transcranial Device
- Keywords
- ageing, photobiomodulation, transcranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR Transcranial phototherapy deviceDevice
1068 nm NIR helmet
Placebo Transcranial DeviceDevice
The placebo device looks like the active device.
| Study group | Role | What they receive |
|---|---|---|
| NIR Transcranial phototherapy device | Active comparator | 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. Receives: Device: NIR Transcranial phototherapy device |
| Placebo Device. | Placebo comparator | Placebo cranial device. The external appearance of the device is identical to that of the active device but no NIR light is emitted. Receives: Device: Placebo Transcranial Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated Neuropsychological Assessment Metrics
Computerised neurophysiological assessment tool
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Jun 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo-controlled, one group received a placebo device and once group an active device.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maculume Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon Dougal, MB ChB, Principal investigator, Maculume Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568057
- Sponsor's protocol ID
- M20Q004
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hawkins KA, Jennings D, Vincent AS, Gilliland K, West A, Marek K. Traditional neuropsychological correlates and reliability of the automated neuropsychological assessment metrics-4 battery for Parkinson's disease. Parkinsonism Relat Disord. 2012 Aug;18(7):864-70. doi: 10.1016/j.parkreldis.2012.04.021. Epub 2012 May 18.
PubMed 22609082Jones WP, Loe SA, Krach SK, Rager RY, Jones HM. Automated neuropsychological assessment metrics (ANAM) and Woodcock-Johnson III Tests of Cognitive Ability: a concurrent validity study. Clin Neuropsychol. 2008 Mar;22(2):305-20. doi: 10.1080/13854040701281483.
PubMed 17853133Naeser MA, Zafonte R, Krengel MH, Martin PI, Frazier J, Hamblin MR, Knight JA, Meehan WP 3rd, Baker EH. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. J Neurotrauma. 2014 Jun 1;31(11):1008-17. doi: 10.1089/neu.2013.3244. Epub 2014 May 8.
PubMed 24568233Barrett DW, Gonzalez-Lima F. Transcranial infrared laser stimulation produces beneficial cognitive and emotional effects in humans. Neuroscience. 2013 Jan 29;230:13-23. doi: 10.1016/j.neuroscience.2012.11.016. Epub 2012 Nov 27.
PubMed 23200785Dougal G, Ennaceur A, Chazot PL. Effect of Transcranial Near-Infrared Light 1068 nm Upon Memory Performance in Aging Healthy Individuals: A Pilot Study. Photobiomodul Photomed Laser Surg. 2021 Oct;39(10):654-660. doi: 10.1089/photob.2020.4956.
PubMed 34662523
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Near Infrared Light 1068 nm Upon Memory Performance in Ageing Healthy Individuals: a Pilot Study.
- ClinicalTrials.gov ID
- NCT04568057
- Acronym / sponsor ID
- M20Q004
- Conditions
- Age-related Cognitive Decline
- Keywords
- ageing, photobiomodulation, transcranial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Maculume Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- The volunteer will have an opportunity to ask questions and have any points of concern clarified.
- Informed consent will be obtained from the volunteer.
- 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).
- 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.
- Testing will be rescheduled if the volunteer has a minor intercurrent illness eg. Flu, minor viral infection.
- After the third ANAM assessment the volunteer will proceed to receive the intervention.
- 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.
- Telephone contact will be made by a researcher with the participant every 2 weeks throughout the intervention period to make the following verbal observations:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo-controlled, one group received a placebo device and once group an active device.
| Arm | Type | Receives |
|---|---|---|
| NIR Transcranial phototherapy device | Active comparator | Device: NIR Transcranial phototherapy deviceThe 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. |
| Placebo Device. | Placebo comparator | Device: Placebo Transcranial DevicePlacebo cranial device. The external appearance of the device is identical to that of the active device but no NIR light is emitted. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIR Transcranial phototherapy device1068 nm NIR helmet | Device | NIR Transcranial phototherapy device |
| Placebo Transcranial DeviceThe placebo device looks like the active device. | Device | Placebo Device. |
Primary outcome
Automated Neuropsychological Assessment Metrics
Time frame: 56 days
Computerised neurophysiological assessment tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 22609082Hawkins KA, Jennings D, Vincent AS, Gilliland K, West A, Marek K. Traditional neuropsychological correlates and reliability of the automated neuropsychological assessment metrics-4 battery for Parkinson's disease. Parkinsonism Relat Disord. 2012 Aug;18(7):864-70. doi: 10.1016/j.parkreldis.2012.04.021. Epub 2012 May 18.
- Background: PubMed 17853133Jones WP, Loe SA, Krach SK, Rager RY, Jones HM. Automated neuropsychological assessment metrics (ANAM) and Woodcock-Johnson III Tests of Cognitive Ability: a concurrent validity study. Clin Neuropsychol. 2008 Mar;22(2):305-20. doi: 10.1080/13854040701281483.
- Background: PubMed 24568233Naeser MA, Zafonte R, Krengel MH, Martin PI, Frazier J, Hamblin MR, Knight JA, Meehan WP 3rd, Baker EH. Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study. J Neurotrauma. 2014 Jun 1;31(11):1008-17. doi: 10.1089/neu.2013.3244. Epub 2014 May 8.
- Background: PubMed 23200785Barrett DW, Gonzalez-Lima F. Transcranial infrared laser stimulation produces beneficial cognitive and emotional effects in humans. Neuroscience. 2013 Jan 29;230:13-23. doi: 10.1016/j.neuroscience.2012.11.016. Epub 2012 Nov 27.
- Derived from this study: PubMed 34662523Dougal G, Ennaceur A, Chazot PL. Effect of Transcranial Near-Infrared Light 1068 nm Upon Memory Performance in Aging Healthy Individuals: A Pilot Study. Photobiomodul Photomed Laser Surg. 2021 Oct;39(10):654-660. doi: 10.1089/photob.2020.4956.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Dougal, MB ChB principal investigator
Maculume Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIR Transcranial phototherapy device in people with Age-related Cognitive Decline, run by Maculume Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automated Neuropsychological Assessment Metrics (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568057, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.