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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIR Transcranial phototherapy device | Device | 1068 nm NIR helmet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Automated Neuropsychological Assessment Metrics | Computerised neurophysiological assessment tool | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Dougal, MB ChB | Maculume Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maculume Ltd | Spennymoor | Durham | DL16 6TR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22609082 | Background | 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. | |
| 17853133 |
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Double-blind placebo-controlled, one group received a placebo device and once group an active device.
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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.
| Placebo Transcranial Device |
| Device |
The placebo device looks like the active device. |
|
| Jones 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. |
| 24568233 | Background | Naeser 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. |
| 23200785 | Background | Barrett 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. |
| 34662523 | Derived | Dougal 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. |