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NCT05097222
Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome
NA trial testing BioFlex Dualport System in Post-Concussive Syndrome, Chronic in 19 participants. Completed in 13 December 2023.
13 December 2023
Quick facts
| Lead sponsor | Dr George Medvedev |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 27 January 2022 |
| Primary completion | 13 December 2023 |
| Estimated completion | 13 December 2023 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- BioFlex Dualport System
- Sham device — full drug profile →
Conditions studied
- Post-Concussive Syndrome, Chronic — all drugs for Post-Concussive Syndrome, Chronic →
- Post-Concussion Syndrome — all drugs for Post-Concussion Syndrome →
- Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
Sponsor
Dr George Medvedev
Who can join
19 and older, any sex, with Post-Concussive Syndrome, Chronic or Post-Concussion Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Photobiomodulation therapy (PBMT) uses light to influence the mitochondria of cells. PBMT of the brain enhances the metabolic capacity of neurons and stimulates anti-inflammatory, anti-apoptotic, and antioxidant responses, as well as neurogenesis and synaptogenesis. Its therapeutic role in disorders such as dementia and Parkinson's disease, as well as to treat stroke, brain trauma, and depression has gained increasing interest. BioFlex is a form of PBMT consisting of light-emitting diodes (LEDs) and laser diodes. BioFlex utilizes red and near infrared light which penetrates tissues up to a certain tissue depth and studies have shown stimulates tissue growth and repair at the cellular level. PBMT has been proven useful for the treatment of soft tissue pain. Several studies have shown benefit in using PBMT in the treatment of certain neurological conditions, including chronic, mild traumatic brain injury (mTBI). The purpose of this exploratory investigation, therefore, is to examine efficacy of BioFlex laser therapy on measures of brain function in patients suffering from PCS after mild-moderate, closed-head, traumatic brain injury cases.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05097222
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other Dr George Medvedev trials
Trials by the same sponsor.
- NCT06428838 — Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05097222 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr George Medvedev
- Last refreshed: 29 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05097222.
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