Photobiomodulation for Concussions: the Use of the ImPACT® Test as an Assessment Tool

Mild Traumatic Brain Injury Clinical Trial

Official title:

Photobiomodulation for Concussions: the Use of the ImPACT® Test to Assess Improvement in Cognition and Symptomatology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823507
• Other study ID #: BFX1
• Status: Completed
• Start date: March 26, 2021
• Est. completion date: March 29, 2021

Study information

• Verified date: March 2021
• Source: Meditech Rehabilitation Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Device:
• BIOFLEX DUO+
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.

Locations

Country	Name	City	State
Canada	Meditech Rehabilitation Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Meditech Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Ruff RM. Mild traumatic brain injury and neural recovery: rethinking the debate. NeuroRehabilitation. 2011;28(3):167-80. doi: 10.3233/NRE-2011-0646. Review. — View Citation

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. Review. — View Citation

Tator 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. Review. — View Citation

Zemek 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. Erratum in: JAMA. 2016 Jun 21;315(23):2624. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks

External Links

•   ICD 10