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

NCT02817061 | Completed Early Phase 1 FDA Device

• 1 other identifier: 2016P001134
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disease Type and/or Category Not Applicable

Keywords

no keywords for disease type and/or category

Outcome Measures

Primary Outcomes (6)

• ERT: Emotional Recognition Task

  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

  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

  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

  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

  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

  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

Study Arms (2)

NIR brain stimulation

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Interventions

Omnilux DEVICE

The Omnilux LED array sources can be changed to emit different wavelength.

NIR brain stimulation; Sham

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (11)

• Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2.

  PMID: 22045511 BACKGROUND

• Lapchak PA. Taking a light approach to treating acute ischemic stroke patients: transcranial near-infrared laser therapy translational science. Ann Med. 2010 Dec;42(8):576-86. doi: 10.3109/07853890.2010.532811. Epub 2010 Nov 1.

  PMID: 21039081 BACKGROUND

• Huang YY, Gupta A, Vecchio D, de Arce VJ, Huang SF, Xuan W, Hamblin MR. Transcranial low level laser (light) therapy for traumatic brain injury. J Biophotonics. 2012 Nov;5(11-12):827-37. doi: 10.1002/jbio.201200077. Epub 2012 Jul 17.

  PMID: 22807422 BACKGROUND

• Naeser MA, Hamblin MR. Traumatic Brain Injury: A Major Medical Problem That Could Be Treated Using Transcranial, Red/Near-Infrared LED Photobiomodulation. Photomed Laser Surg. 2015 Sep;33(9):443-6. doi: 10.1089/pho.2015.3986. Epub 2015 Aug 17. No abstract available.

  PMID: 26280257 BACKGROUND

• Xuan W, Vatansever F, Huang L, Hamblin MR. Transcranial low-level laser therapy enhances learning, memory, and neuroprogenitor cells after traumatic brain injury in mice. J Biomed Opt. 2014;19(10):108003. doi: 10.1117/1.JBO.19.10.108003.

  PMID: 25292167 BACKGROUND

• Xuan W, Agrawal T, Huang L, Gupta GK, Hamblin MR. Low-level laser therapy for traumatic brain injury in mice increases brain derived neurotrophic factor (BDNF) and synaptogenesis. J Biophotonics. 2015 Jun;8(6):502-11. doi: 10.1002/jbio.201400069. Epub 2014 Sep 8.

  PMID: 25196192 BACKGROUND

• Farfara D, Tuby H, Trudler D, Doron-Mandel E, Maltz L, Vassar RJ, Frenkel D, Oron U. Low-level laser therapy ameliorates disease progression in a mouse model of Alzheimer's disease. J Mol Neurosci. 2015 Feb;55(2):430-6. doi: 10.1007/s12031-014-0354-z. Epub 2014 Jul 4.

  PMID: 24994540 BACKGROUND

• Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Front Neurosci. 2016 Jan 11;9:500. doi: 10.3389/fnins.2015.00500. eCollection 2015.

  PMID: 26793049 BACKGROUND

• Schiffer F, Johnston AL, Ravichandran C, Polcari A, Teicher MH, Webb RH, Hamblin MR. Psychological benefits 2 and 4 weeks after a single treatment with near infrared light to the forehead: a pilot study of 10 patients with major depression and anxiety. Behav Brain Funct. 2009 Dec 8;5:46. doi: 10.1186/1744-9081-5-46.

  PMID: 19995444 BACKGROUND

• Michalikova S, Ennaceur A, van Rensburg R, Chazot PL. Emotional responses and memory performance of middle-aged CD1 mice in a 3D maze: effects of low infrared light. Neurobiol Learn Mem. 2008 May;89(4):480-8. doi: 10.1016/j.nlm.2007.07.014. Epub 2007 Sep 12.

  PMID: 17855128 BACKGROUND

• Blanco NJ, Maddox WT, Gonzalez-Lima F. Improving executive function using transcranial infrared laser stimulation. J Neuropsychol. 2017 Mar;11(1):14-25. doi: 10.1111/jnp.12074. Epub 2015 May 28.

  PMID: 26017772 BACKGROUND

Study Officials

• R. Rox Anderson, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Wellman Center for Photomedicine

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 29, 2016
• Study Start: March 27, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)