Traumatic Brain InjuryLEDNCT01598532
Effects of LEDs on Memory in TBI Patients
A study testing MedX Health Phototherapy (light therapy) in people with Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- MedX Health Phototherapy (light therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, Ages 18-65
- sustained a mild traumatic brain injury(mTBI) at least 6 months ago
- mTBI is defined as < 30 minutes loss of consciousness and <30 minutes, post trauma amnesia
- since the injury patient continues having problems with memory and thinking ability
Who cannot join
- Younger than 18 or older than 65
- mTBI occured less than 6 months ago
- moderate to severe Traumatic Brain Injury (TBI)
- non-closed head injury
- presence of craniotomy, craniectomy, or ventriculoperitoneal shunt
- Non-English speaking subjects - Neuropsychological Tests only in English
- Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
Official title: Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study
The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.
Read the detailed description
This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.
Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.
- Conditions
- Traumatic Brain Injury
- Being tested
- MedX Health Phototherapy (light therapy)
- Keywords
- mild traumatic brain injury, mild TBI, mTBI
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedX Health Phototherapy (light therapy)Device
The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial LED Treatment | Experimental | All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration. Receives: Device: MedX Health Phototherapy (light therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Test for Executive Function - Trial 3 - Inhibition
Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Measured: Baseline and 1-Week, 1-month and 2-months after final LED Treatment
Stroop Test for Executive Function - Trial 4 Inhibition Switching
Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Measured: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5
California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Measured: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Measured: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Controlled Oral Word Association Test (FAS)
Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Measured: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Digit Span, Forwards and Backwards
Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Measured: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startSep 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital
- Investigators
- Ross D Zafonte, DO, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598532
- Sponsor's protocol ID
- 2009-P-001552
- Acronym
- LED
- Status last verified
- Aug 2016
- First submitted
- 4 May 2012
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013.
PubMed 21172691Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2010.2814. Epub 2010 Dec 23.
PubMed 21182447
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study
- ClinicalTrials.gov ID
- NCT01598532
- Acronym / sponsor ID
- LED / 2009-P-001552
- Conditions
- Traumatic Brain Injury
- Keywords
- mild traumatic brain injury, mild TBI, mTBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 22 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.
Detailed description
This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.
Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial LED Treatment | Experimental | Device: MedX Health Phototherapy (light therapy)All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, Ages 18-65
- sustained a mild traumatic brain injury(mTBI) at least 6 months ago
- mTBI is defined as < 30 minutes loss of consciousness and <30 minutes, post trauma amnesia
- since the injury patient continues having problems with memory and thinking ability
Key exclusion criteria (7 listed)
- Younger than 18 or older than 65
- mTBI occured less than 6 months ago
- moderate to severe Traumatic Brain Injury (TBI)
- non-closed head injury
- presence of craniotomy, craniectomy, or ventriculoperitoneal shunt
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 |
|---|---|---|
| MedX Health Phototherapy (light therapy)The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each. | Device | Transcranial LED Treatment |
Primary outcome
Stroop Test for Executive Function - Trial 3 - Inhibition
Time frame: Baseline and 1-Week, 1-month and 2-months after final LED Treatment
Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Stroop Test for Executive Function - Trial 4 Inhibition Switching
Time frame: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment
Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5
Time frame: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment
California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall
Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Controlled Oral Word Association Test (FAS)
Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Digit Span, Forwards and Backwards
Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21172691Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013.
- Results publication: PubMed 21182447Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2010.2814. Epub 2010 Dec 23.
- Department of Physical Medicine and Rehabilitation at Spaulding Hospital - ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ross D Zafonte, DO principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedX Health Phototherapy (light therapy) in people with Traumatic Brain Injury, run by Spaulding Rehabilitation 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 7 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 30 Sep 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stroop Test for Executive Function - Trial 3 - Inhibition (time frame: Baseline and 1-Week, 1-month and 2-months after final LED Treatment). 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 NCT01598532, which also lists 2 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 30 Sep 2016.