Disease Type and/or Category Not ApplicableEarly Phase 1ELECTRANCT02817061
Effectiveness of Light for Enhancement of Cognition by Transcranial Repeated Application (ELECTRA)
A Early Phase 1 study testing Omnilux in people with Disease Type and/or Category Not Applicable, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease Type and/or Category Not Applicable
- What is being tested?
- Omnilux
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 1 Sep 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Being tested
- Omnilux
- Keywords
- no keywords for disease type and/or category
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniluxDevice
The Omnilux LED array sources can be changed to emit different wavelength.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Omnilux |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start27 Mar 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Disease Type and/or Category Not ApplicableStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
- Investigators
- R. Rox Anderson, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817061
- Sponsor's protocol ID
- 2016P001134
- Acronym
- ELECTRA
- Status last verified
- Feb 2026
- First submitted
- 16 Jun 2016
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will only be shared within the study staff member on the approved Institutional Review Board MGH protocol and to the sponsor, the AFOSR
Publications
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.
PubMed 22045511Lapchak 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.
PubMed 21039081Huang 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.
PubMed 22807422Naeser 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.
PubMed 26280257Xuan 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.
PubMed 25292167Xuan 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.
PubMed 25196192Farfara 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.
PubMed 24994540Johnstone 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.
PubMed 26793049Schiffer 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.
PubMed 19995444Michalikova 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.
PubMed 17855128Blanco 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.
PubMed 26017772
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02817061
- Acronym / sponsor ID
- ELECTRA / 2016P001134
- Keywords
- no keywords for disease type and/or category
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIR brain stimulation | Experimental | Device: OmniluxAn 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. |
| Sham | Sham comparator | Device: OmniluxAn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmniluxThe Omnilux LED array sources can be changed to emit different wavelength. | Device | NIR brain stimulation, Sham |
Primary outcome
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.
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
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 22045511Chung 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.
- Background: PubMed 21039081Lapchak 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.
- Background: PubMed 22807422Huang 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.
- Background: PubMed 26280257Naeser 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.
- Background: PubMed 25292167Xuan 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.
- Background: PubMed 25196192Xuan 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.
- Background: PubMed 24994540Farfara 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.
- Background: PubMed 26793049Johnstone 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.
- Background: PubMed 19995444Schiffer 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.
- Background: PubMed 17855128Michalikova 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.
- Background: PubMed 26017772Blanco 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.
- Individual participant dataSharing planned: Yes. Data will only be shared within the study staff member on the approved Institutional Review Board MGH protocol and to the sponsor, the AFOSR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Rox Anderson, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omnilux in people with Disease Type and/or Category Not Applicable, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERT: Emotional Recognition Task (time frame: 16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817061, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.