BioFlex Dualport System for Post-Concussion Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Meditech Rehabilitation Centre, Etobicoke, CanadaPost-Concussion Syndrome+2 MoreBioFlex Dualport System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether light therapy can help improve symptoms for people who have post-concussion syndrome after a mild to moderate brain injury.

Eligible Conditions
  • Post-Concussion Syndrome
  • Post Concussive Syndrome, Chronic
  • Concussion

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Visit 1/Baseline to Visit 3/End of Treatment (8 weeks)

Week 8
Number of adverse device effects
Number of adverse events
Pain Catastrophizing Scale Score
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform 2
Rivermead Post-Concussion Symptoms Questionnaire Score

Trial Safety

Trial Design

2 Treatment Groups

Active PBMT
1 of 2
Sham PBMT
1 of 2

Experimental Treatment

Non-Treatment Group

20 Total Participants · 2 Treatment Groups

Primary Treatment: BioFlex Dualport System · Has Placebo Group · N/A

Active PBMT
Device
Experimental Group · 1 Intervention: BioFlex Dualport System · Intervention Types: Device
Sham PBMT
Device
ShamComparator Group · 1 Intervention: Sham device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: visit 1/baseline to visit 3/end of treatment (8 weeks)

Who is running the clinical trial?

Dr George MedvedevLead Sponsor
MediTech International Inc.UNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

What is the current roster for participants in this medical trial?

"Affirmative, the clinical trial is indeed recruiting. According to records hosted on clinicaltrials.gov, it was posted on January 27th 2022 and most recently edited on August 8th 2022 with a recruitment goal of 20 people at 2 different sites." - Anonymous Online Contributor

Unverified Answer

Is recruitment for this project ongoing?

"Absolutely. The clinical trial website indicates that this research initiative, which was published on January 27th 2022, is actively recruiting participants. At the moment, there are 20 openings across two different sites." - Anonymous Online Contributor

Unverified Answer

What are the chief aims of this experiment?

"This medical trial has two primary goals. Firstly, to assess the response timing of ERPs (N100, P300 and N400) gathered from NeuroCatch Platform 2 over an 8-week period. Secondly, researchers are looking at Rivermead Post Concussion Symptoms Questionnaire Score (ranging 0-64), Pain Catastrophizing Scale Score (0-52) and Number of Adverse Device Effects for secondary outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.