Effect of Transcranial NIR Light Upon Memory

NCT04568057 | Completed

• 1 other identifier: M20Q004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Cognitive Decline

Keywords

ageing; photobiomodulation; transcranial

Outcome Measures

Primary Outcomes (1)

• Automated Neuropsychological Assessment Metrics

  Computerised neurophysiological assessment tool

  56 days

Study Arms (2)

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.

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.

Device: Placebo Transcranial Device

Interventions

NIR Transcranial phototherapy device DEVICE

1068 nm NIR helmet

NIR Transcranial phototherapy device

Placebo Transcranial Device DEVICE

The placebo device looks like the active device.

Placebo Device.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Maculume Ltd.: lead

Study Sites (1)

Maculume Ltd

Spennymoor, Durham, DL16 6TR, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 22609082 BACKGROUND

• 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.

  PMID: 17853133 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.

  PMID: 24568233 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.

  PMID: 23200785 BACKGROUND

• 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.

  PMID: 34662523 DERIVED

Study Officials

• Gordon Dougal, MB ChB

  Maculume Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind placebo-controlled, one group received a placebo device and once group an active device.

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 29, 2020
• Study Start: June 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 23, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)