Mild Traumatic Brain InjuryNCT04823507
Photobiomodulation for Concussions: the Use of the ImPACT® Test as an Assessment Tool
An observational study of Mild Traumatic Brain Injury, run by Meditech Rehabilitation Centre at 1 site in Canada.
Trial summary
Brain photobiomodulation (PBM) therapy is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- BIOFLEX DUO+
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2021to 29 Mar 2021
- Phase
- Observational
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data will be collected for all patients diagnosed with post-concussion syndrome who sought consult and treated using photobiomodulation therapy at Meditech Rehabilitation Centre using the BIOFLEX® DUO+ system
Who may be able to join
- Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018.
- Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4.
Who cannot join
- Any positive findings on imaging studies
- A diagnosis of or a family history of neuropsychiatric co-morbidity.
- Any additional diagnoses compounding the diagnosis of a concussion or mild traumatic brain injury (TBI)
- Currently undergoing any type of therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photobiomodulation for Concussions: the Use of the ImPACT® Test to Assess Improvement in Cognition and Symptomatology
Brain photobiomodulation (PBM) therapy is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders. Our emphasis on this study is to review the use of PBM as a treatment modality for concussions and the use of ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) test to assess improvement in cognition and symptomatology in patients with post-concussion syndrome (PCS) treated with PBM.
Read the detailed description
- This will be a retrospective, single arm, unmasked, clinical study.
- Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
- Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
- Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
- Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- BIOFLEX DUO+
- Keywords
- Concussion, Photobiomodulation, ImPACT
- Medical subject headings
- Brain Concussion, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOFLEX DUO+Device
Also called ImPACT test
- Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
- Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
- Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
- Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Concussion patients treated with Photobiomodulation | * Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018.
* Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4. Receives: Device: BIOFLEX DUO+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ImPACT test scores after treatment with Photobiomodulation.
- Statistically significant change in measured metrics for Workplace Post injury 2 ImPACT® outcome scores compared to Workplace Post injury 1 ImPACT® scores for patients in the study population.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start26 Mar 2021
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meditech Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zitney, MD, Principal investigator, Meditech Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823507
- Sponsor's protocol ID
- BFX1
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only overall outcomes will be shared.
Publications
Salehpour F, Mahmoudi J, Kamari F, Sadigh-Eteghad S, Rasta SH, Hamblin MR. Brain Photobiomodulation Therapy: a Narrative Review. Mol Neurobiol. 2018 Aug;55(8):6601-6636. doi: 10.1007/s12035-017-0852-4. Epub 2018 Jan 11.
PubMed 29327206Tator CH. Concussions and their consequences: current diagnosis, management and prevention. CMAJ. 2013 Aug 6;185(11):975-9. doi: 10.1503/cmaj.120039. Epub 2013 Jul 22. No abstract available.
PubMed 23877672Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
PubMed 26954410Ruff RM. Mild traumatic brain injury and neural recovery: rethinking the debate. NeuroRehabilitation. 2011;28(3):167-80. doi: 10.3233/NRE-2011-0646.
PubMed 21558623
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation for Concussions: the Use of the ImPACT® Test to Assess Improvement in Cognition and Symptomatology
- ClinicalTrials.gov ID
- NCT04823507
- Acronym / sponsor ID
- BFX1
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Concussion, Photobiomodulation, ImPACT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Meditech Rehabilitation CentreUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 30 Mar 2021 (actual)
- 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.
Brain photobiomodulation (PBM) therapy is an innovative modality for the stimulation of neural activity in order to improve brain function and is currently under investigation as a treatment for several diverse neurological disorders. Our emphasis on this study is to review the use of PBM as a treatment modality for concussions and the use of ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) test to assess improvement in cognition and symptomatology in patients with post-concussion syndrome (PCS) treated with PBM.
Detailed description
- This will be a retrospective, single arm, unmasked, clinical study.
- Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
- Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
- Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
- Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concussion patients treated with Photobiomodulation | – | Device: BIOFLEX DUO+* Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018. * Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data will be collected for all patients diagnosed with post-concussion syndrome who sought consult and treated using photobiomodulation therapy at Meditech Rehabilitation Centre using the BIOFLEX® DUO+ system
Key inclusion criteria (2 listed)
- Patients between the ages of 15-65 years clinically diagnosed with a mild Traumatic Brain Injury by a health professional and currently not undergoing any treatment during a 1 year period from January 2018 to December 2018.
- Documentation of the history of a qualifying mild Traumatic Brain Injury within 3 months of traumatic incident and/or diagnosis with persistent symptomatology after 3 months. For reference, International Classification of Diseases, Tenth Revision (ICD-10) clinical criteria require a history of TBI and the presence of three or more of the following eight symptoms: 1) headache, 2) dizziness, 3) fatigue, 4) irritability, 5) insomnia, 6) concentration or 7) memory difficulty, and 8) intolerance of stress, emotion, or alcohol4.
Key exclusion criteria (4 listed)
- Any positive findings on imaging studies
- A diagnosis of or a family history of neuropsychiatric co-morbidity.
- Any additional diagnoses compounding the diagnosis of a concussion or mild traumatic brain injury (TBI)
- Currently undergoing any type of therapy
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 |
|---|---|---|
| BIOFLEX DUO+Also: ImPACT test* Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment. * Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine. * Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test. * Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared. | Device | Concussion patients treated with Photobiomodulation |
Primary outcome
Improvement in ImPACT test scores after treatment with Photobiomodulation.
Time frame: 4 weeks
• Statistically significant change in measured metrics for Workplace Post injury 2 ImPACT® outcome scores compared to Workplace Post injury 1 ImPACT® scores for patients in the study population.
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 1 Apr 2021.
- Background: PubMed 29327206Salehpour F, Mahmoudi J, Kamari F, Sadigh-Eteghad S, Rasta SH, Hamblin MR. Brain Photobiomodulation Therapy: a Narrative Review. Mol Neurobiol. 2018 Aug;55(8):6601-6636. doi: 10.1007/s12035-017-0852-4. Epub 2018 Jan 11.
- Background: PubMed 23877672Tator CH. Concussions and their consequences: current diagnosis, management and prevention. CMAJ. 2013 Aug 6;185(11):975-9. doi: 10.1503/cmaj.120039. Epub 2013 Jul 22. No abstract available.
- Background: PubMed 26954410Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
- Background: PubMed 21558623Ruff RM. Mild traumatic brain injury and neural recovery: rethinking the debate. NeuroRehabilitation. 2011;28(3):167-80. doi: 10.3233/NRE-2011-0646.
- ICD 10Link provided by the sponsor.
- Individual participant dataSharing planned: No. Only overall outcomes will be shared.
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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.
Michael Zitney, MD principal investigator
Meditech Rehabilitation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Meditech Rehabilitation Centre at 1 site in Canada.
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 2 inclusion and 4 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 1 Apr 2021. 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 Canada. 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?
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?
Improvement in ImPACT test scores after treatment with Photobiomodulation. (time frame: 4 weeks). 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 NCT04823507, which also lists 4 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 1 Apr 2021.