NCT04823507

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Meditech Rehabilitation Centre · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-26
• Primary completion: 2021-03-29
• Completion: 2021-03-29
• First posted: 2021-03-30
• Last updated: 2021-04-01

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study