Effect of Transcranial NIR Light Upon Memory

February 22, 2021 updated by: Maculume Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Durham
      • Spennymoor, Durham, United Kingdom, DL16 6TR
        • Maculume Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NIR Transcranial phototherapy device
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
1068 nm NIR helmet
Placebo Comparator: Placebo Device.
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
The placebo device looks like the active device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated Neuropsychological Assessment Metrics
Time Frame: 56 days
Computerised neurophysiological assessment tool
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maculume Ltd.

Investigators

  • Principal Investigator: Gordon Dougal, MB ChB, Maculume Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20Q004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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