Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA) (ELECTRA)

February 26, 2026 updated by: Richard Rox Anderson, MD, Massachusetts General Hospital

Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA): a Placebo-Controlled Study of Efficacy, Tolerability and Acceptability in Healthy Adult Volunteers

Aim: Investigate whether transcranial photobiomodulation (tPBM) using near-infrared light exposure to the head, can improve frontal lobe executive function, working memory and overall mood in normal volunteer participants.

Hypothesis: The investigators predict that tPBM will increase cognitive functioning, as measured by Cambridge Cognition cognitive testing in study subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Photobiomodulation (PBM), also called low-level light therapy (LLLT), uses optical power densities less than 100 mW/cm², and usually in the red (600-700 nm) or near infrared (NIR) 780-1000 nm wavelength range. Different light sources (coherent lasers or non-coherent LEDs) used for PBM have been shown to produce beneficial cellular effects and to be responsible for preservation and recovery of tissue function in controlled trials in a wide range of disorders typified by stress injury or degeneration. During PBM, absorption of red or near-infrared photons by cytochrome c oxidase in the mitochondrial respiratory chain causes an increase in cellular respiration that continues for much longer than the light is present when delivered at appropriate fluence and exposure durations.

Primary cellular effects include increases in mitochondrial activity and ATP levels, production of low levels of reactive oxygen species, induction of transcription factors (including the pro- survival NF-kB), and inhibition of apoptosis.

Over the past decade several studies have reported that a single, transcranial PBM treatment at 810 nm delivered to the head had significant, beneficial effect when used to treat acute ischemic stroke in several different animal models and also in human clinical trials. A similar approach was used to treat acute traumatic brain injury (TBI) in mice and in humans. Pathological examination of the mouse brains demonstrated up- regulation of brain-derived neurotrophic factor (BDNF) and stimulated neurogenesis in the hippocampus and increased synaptogenesis in the cortex.

A clinical trial is currently in progress at MGH to treat persons with acute moderate TBI. Several studies have shown improvement of cognitive function in persons with chronic TBI. Studies have also been conducted in animal models and in persons with Alzheimer's disease, Parkinson's disease, depression and anxiety.

Only a very limited number of studies have so far been carried out to test NIR photobiomodulation in normal experimental rodents and in normal human volunteers.

In this study, an LED array light source will be used that has been cleared by the FDA for other human uses.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

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 States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 18-25 or 65-85
  • Women of child-bearing potential, must use a double-barrier method for birth control (e.g. condoms with spermicide) if sexually active during the study and for 30 days post treatment of any kind.
  • Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
  • The subject (and caregiver, if applicable) is willing to participate in this study for at least 12 weeks.

Exclusion Criteria:

  • Inability to speak or read English (necessary for cognitive testing software use).
  • Pregnancy or lactation
  • History of stroke or traumatic brain injury
  • Substance dependence or abuse in the past 6 months
  • Diagnosis with major psychiatric disease (Psychotic disorder or psychotic episode, bipolar affective disorder)
  • Diagnosed with a neurodevelopmental condition (autism or ADHD)
  • A traumatic event that resulted in PTSD
  • Any unstable medical illness (defined as any medical illness which has not been well-controlled with standard-of-care medications)
  • A significant skin condition (i.e., hemangioma, scleroderma, rash, open wound) or medical implant (e.g. metal plate, implantable shunt or valve) on the head.
  • Inability to understand or participate in the consent and performance of the study.
  • Those with Parkinson's Disease, End Stage Renal Disease, and/or End Stage Liver Disease

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIR brain stimulation

An Omnilux device will be used to put NIR light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.

An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
Device: Omnilux
The Omnilux LED array sources can be changed to emit different wavelength.
Sham Comparator: Sham

An Omnilux Device will be used at a safe wavelength not associated with photobiomodulation, putting sham light on the head and forehead of the subject age 18-25 or 65-85. The device is a low risk device as determined by the IRB. Thirty (30) subjects will receive this light at 6 visits over 16 weeks.

An automated interactive software self-test will be used at baseline and at three subsequent visits to quantify subject cognitive functions.
Device: Omnilux
The Omnilux LED array sources can be changed to emit different wavelength.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ERT: Emotional Recognition Task
Time Frame: 16 weeks
The median latency from stimulus onset to the subject's response button touch (i.e. emotion chosen) for all problems during assessment blocks.
16 weeks
PAL: Paired Associates Learning
Time Frame: 16 weeks
The number of times the subject chose the incorrect box for a stimulus on assessment problems, plus an adjustment for the estimated number of errors they would have made on any problems, attempts and recalls they did not reach
16 weeks
RTI: Reaction Time
Time Frame: 16 weeks
The mean duration between the onset of the stimulus and the release of the button. Calculated for correct, assessed trials where the stimulus could appear in any one of five locations.
16 weeks
RVP: Rapid Visual Information Processing
Time Frame: 16 weeks
A' (A prime) is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the subject is at detecting target sequences.
16 weeks
SST: Stop Signal Task
Time Frame: 16 weeks
The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials.
16 weeks
SWM: Spatial Working Memory
Time Frame: 16 weeks
Between errors are defined as times the subject revisits a box in which a token has previously been found. This is calculated for trials of four, six and eight tokens.
16 weeks

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: R. Rox Anderson, MD, MGH

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)

March 27, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimated)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P001134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will only be shared within the study staff member on the approved Institutional Review Board MGH protocol and to the sponsor, the AFOSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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.

Clinical Trials on Disease Type and/or Category Not Applicable

Clinical Trials on Omnilux

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe