Post-Concussive Syndrome, ChronicNCT05097222
Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome
A study testing BioFlex Dualport System in people with Post-Concussive Syndrome, Chronic and Post-Concussion Syndrome, run by Dr George Medvedev at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post-Concussive Syndrome, Chronic, Post-Concussion Syndrome, Mild Traumatic Brain Injury
- What is being tested?
- BioFlex Dualport System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Jan 2022to 13 Dec 2023
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 19 years of age or older
- Diagnosis of persistent post-concussional syndrome after ≥3 months of traumatic brain injury, based on the ICD-10 criteria. This diagnosis should be given to the patient from a clinical practitioner. 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 alcohol.
- Current pharmacologic management can remain stable throughout the protocol.
- Fluent in English
- Able to understand the informed consent form, study procedures and willing to participate in study.
Who cannot join
- Malignant skin carcinoma within the treatment area (neck and cranium)
- Intake of photosensitizing medication.
- Prior history of PBMT therapy
- Current diagnosis of severe anxiety (or score of ≥15 on the GAD-7), severe depression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder
- History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)
- Diagnosed epilepsy or history of seizures not effectively controlled by medications
Show all 10Show fewer
- Exposed to an investigational drug or device 30 days prior to starting the study, or concurrent use of an investigational drug or device while enrolled in the study
- Pregnant, suspected to be pregnant or planning to become pregnant during the study
- Contraindicated for the NeuroCatch® Platform 2, including:
- 9.1. Requires the use of hearing aids or a cochlear implant 9.2. Diagnosed with tinnitus that is currently active 9.3. Has temporary damage to hearing (e.g. punctured ear drum) 9.4. Unable to detect a 740Hz tone played at 85dB in both ears. 9.5. Implanted pacemaker or implanted electrical stimulators 9.6. Metal or plastic implants in the skull, excluding dental/facial implants 9.7. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin) 9.8. Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Meditech Rehabilitation Centre
Etobicoke, Ontario, M8W 4W3
Center for Neurology Studies
Surrey, British Columbia, V3V 0C6
About this study
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.
- Being tested
- BioFlex Dualport System, Sham device
- Medical subject headings
- Post-Concussion Syndrome, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFlex Dualport SystemDevice
Also called Photobiomodulation
The device consists of a laptop computer preprogrammed with the Bioflex® Practitioner+ Software, the Bioflex® DUO 180+ array pad that has 180 bicolour Light Emitting Diodes (LED) that emit red and near infrared light, and two laser probes, the LD-R 100 that emits red light, and the LD-I 200 that emits near infrared light.
Sham deviceDevice
Control
| Study group | Role | What they receive |
|---|---|---|
| Active PBMT | Experimental | Participants will receive 50minutes of PBMT, three times a week, for 8 weeks. Receives: Device: BioFlex Dualport System |
| Sham PBMT | Sham comparator | Participants will receive 50minutes of Sham PBMT, three times a week, for 8 weeks. The Sham device will appear to function like the treatment device without providing any power intensity (0% power). At 0% power, no light is emitted from the LEDs. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Event-related potentials (ERPs)
Measured: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Event-related potentials (ERPs)
Measured: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Secondary outcomes (4)
Number of adverse events
Frequency and severity of adverse events
Measured: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Number of adverse device effects
Frequency and severity of adverse device effects
Measured: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Pain Catastrophizing Scale Score
Mean, standard deviation, and assessment of variance. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
Measured: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Rivermead Post-Concussion Symptoms Questionnaire Score
Mean, standard deviation, and assessment of variance. Scored on a scale of 0-64 where higher scores reflect greater severity of post concussive symptoms.
Measured: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start27 Jan 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussive Syndrome, ChronicStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr George Medvedev
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MediTech International Inc.
- Responsible party
- Sponsor-investigator, Dr George Medvedev, HealthTech Connex Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097222
- Sponsor's protocol ID
- BioFlex_PCS_001
- Status last verified
- May 2024
- First submitted
- 15 Oct 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Photobiomodulation on Objective, Physiological Measures of Brain Function in Individuals With Post-Concussion Syndrome
- ClinicalTrials.gov ID
- NCT05097222
- Acronym / sponsor ID
- BioFlex_PCS_001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dr George MedvedevIndustry (pharma, biotech, devices)
- Collaborators
- MediTech International Inc.
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 28 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PBMT | Experimental | Device: BioFlex Dualport SystemParticipants will receive 50minutes of PBMT, three times a week, for 8 weeks. |
| Sham PBMT | Sham comparator | Device: Sham deviceParticipants will receive 50minutes of Sham PBMT, three times a week, for 8 weeks. The Sham device will appear to function like the treatment device without providing any power intensity (0% power). At 0% power, no light is emitted from the LEDs. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, at least 19 years of age or older
- Diagnosis of persistent post-concussional syndrome after ≥3 months of traumatic brain injury, based on the ICD-10 criteria. This diagnosis should be given to the patient from a clinical practitioner. 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 alcohol.
- Current pharmacologic management can remain stable throughout the protocol.
- Fluent in English
- Able to understand the informed consent form, study procedures and willing to participate in study.
Key exclusion criteria (10 listed)
- Malignant skin carcinoma within the treatment area (neck and cranium)
- Intake of photosensitizing medication.
- Prior history of PBMT therapy
- Current diagnosis of severe anxiety (or score of ≥15 on the GAD-7), severe depression (or score of ≥20 on the PHQ-9), schizophrenia or bipolar disorder
- History of other major neurological disorder (brain cancer, dementia, multiple sclerosis, stroke)
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 Dualport SystemAlso: PhotobiomodulationThe device consists of a laptop computer preprogrammed with the Bioflex® Practitioner+ Software, the Bioflex® DUO 180+ array pad that has 180 bicolour Light Emitting Diodes (LED) that emit red and near infrared light, and two laser probes, the LD-R 100 that emits red light, and the LD-I 200 that emits near infrared light. | Device | Active PBMT |
| Sham deviceControl | Device | Sham PBMT |
Primary outcome
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Event-related potentials (ERPs)
Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Event-related potentials (ERPs)
4 secondary outcomes
Number of adverse events
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Number of adverse device effects
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Pain Catastrophizing Scale Score
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
Rivermead Post-Concussion Symptoms Questionnaire Score
Time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)
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 29 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFlex Dualport System in people with Post-Concussive Syndrome, Chronic and Post-Concussion Syndrome, run by Dr George Medvedev at 2 sites 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 5 inclusion and 10 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2 (time frame: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.