ConcussionNCT04946747
Detection and Prevention of Concussive Injuries With Smart Technology.
A study testing Modern microelectrical mechanical systems (MEMS) head-impact sensors, Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus and Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus in people with Concussion and Head Injury Trauma, run by Chi-Ming Huang.
Trial summary
Concussions are consequences of inopportune interactions between an impact force and the head that causes the head (and brain) to move too rapidly. This project involves two parts. 1. The outcome of head-impact depends upon the force and the biomechanical properties of the head-and-neck. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Concussion, Head Injury Trauma
- What is being tested?
- Modern microelectrical mechanical systems (MEMS) head-impact sensors, Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus and Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to 10 Apr 2022
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Local soccer academy soccer player, Age 7-17,
- Agrees to participate in study, (signed Assent),
- Parent agrees to child's participation in study (signed consent)
Who cannot join
- Any individual who does not agree to participate,
- Any individual whose parent does not agree to having their child participate,
- Individual who is unable or unwilling to wear a sensor
Trial locations and contacts
No sites are listed yet.
Chiming Huang, PhD contact
About this study
Concussions are consequences of inopportune interactions between an impact force and the head that causes the head (and brain) to move too rapidly. This project involves two parts.
- The outcome of head-impact depends upon the force and the biomechanical properties of the head-and-neck. Modern microelectrical mechanical systems (MEMS) head-impact sensors only measure the physical parameters of external forces. The researchers have developed a next-generation smart MEMS sensor fortified with artificial intelligence (AI) that can help define a personalized concussive threshold. The researchers sensor machine-learns the biomechanical properties of the participant's head-and-neck and accurately determines the likelihood for concussive injuries. The researchers first goal is to field-test the sensor in soccer players.
- Researchers hypothesize that an increase in neck stiffness should reduce concussive risks. The researchers have developed a training protocol that involves a conditioned response (CR) to increase neck stiffness during a head-impact event and thereby decrease concussion risk. The Researchers have also developed technology to monitor neck stiffness.
The smart sensor is fully integrated into the training protocol and monitors the neck stiffness to validate the effectiveness of the training. The second goal is to optimize and finalize our training protocol and conduct a field-test in soccer players.
Read the detailed description
The hypothesis is that MEMS sensors fortified with artificial intelligence and machine learning can incorporate individualized human factors into consideration and help to define concussive threshold for diagnosis that is personalized as in precision medicine. In laboratory tests, the prototype smart sensor the researchers built can machine-learn the biomechanical properties of the head-and-neck of the user without being programmed with that information. It then measures the magnitude of the impact against a personalized threshold of the user, in real time. These capabilities allow the smart sensor to accurately determine the potential for concussive injuries for a given individual.
The first aim is (a) to optimize and finalize the sensor into a wearable, field-test-ready prototype and (b) to conduct a field-test in soccer players in order to examine the accuracy of the sensors in setting personalized concussive thresholds.
The hypothesis is that the dynamic increase in neck stiffness should reduce concussive risks significantly. The smart sensor is fully integrated into the training in order to monitor the increase in neck stiffness and validate the effectiveness of the acquired CR in reducing concussion risks.
The second aim therefore is (a) to optimize and finalize our training protocol and (b) to conduct a field-test in soccer players.
The long-term objectives are to develop methods and technology for rapid and reliable concussion risk assessment in the field as well as for the prevention and mitigation of concussive injuries.
PROCEDURES
Part 1 of study:
Study information will be given to parents and soccer players (study participants) by Dr. Moncure and Dr. Huang at the Local soccer academy during normal hours. This will be a one-time session for approximately 1 hour, depending on questions.
The study information provided by investigators will also be recorded on video in order to assure that all parents and soccer players receive the same information even if they are not present at the meeting.
All players will be given the opportunity to participate based on inclusion and exclusion criteria.
Informed Consent and Assent will be reviewed with participants and parents by Dr. Moncure at the Local soccer academy after parents and soccer players have been fully informed of the study and their participation requirements. All participants and their parents must attend the informational session or watch the study informational video prior to participation. All study related questions will be answered by the Dr. Moncure or Dr. Huang. Completing the ICF and Assent will occur after the study informational session and will take approximately 30 minutes.
A Training session will be held to show all Local soccer academy trainers how the sensors work and how the sensors are affixed to the players. Later, the trainers will see to it that the soccer players will properly wear the sensors every time during practice. This training session will take approximately 30 minutes.
Once a participant has been enrolled, the participant can begin wearing the sensor during training or playing soccer at Local soccer academy. Sensors will be worn over a period of at least 4 weeks when the players are at the Local soccer academy. The participant has completed Part 1 at the end of 4 weeks. The purpose of Part 1 is to collect head movement data from the soccer players before concussion avoidance training.
Part 2 of study:
Randomization of participants will occur. Participants will be randomized into 2 groups -- Trained group and Control group.
Trainers will be shown how to conduct the Virtual Reality (VR) training session. Trainers will be shown proper placement of the head-impact sensor system to measure participant response to training.
After Part 1 of the study has been completed, the participants will be randomized and divided into the Trained group and the Control group. Considerations will be given to obtain the best possible age-match and gender match in the Trained group and the control group. Both groups will be shown how to use the Virtual Reality goggles. During the one to two week VR training period, both groups will be using the VR goggles. The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge. The Control group will also receive the same CS and the same US, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge. Both groups will also wear our smart head-impact sensor system to measure their response to training. One purpose of this arrangement is to provide an avenue for a double-blind analysis. A second purpose will be the provision for an age-and gender-matched control group for the study.
CR training will be carried out over a period of approximately 10 days with daily 30-minute sessions (or roughly over a period of one to two weeks). The training involves wearing the VR goggles and our smart head-impact sensor system (head sensor and body sensor), at the local soccer academy in the training area. The participant will receive virtual visual stimuli of usual soccer play as CS. The participant will also receive a mildly unpleasant auditory stimuli (such as those from a coach) as US. The training will be done in the local soccer academy training room, with only those randomized participants and their trainers present.
The Control group will also participate in VR training but will not know that they are in the Control group. All data will be kept within software that comes with the sensors and VR goggles.
Once the CR training has been completed, all participants will again wear our smart sensors whenever they are playing soccer at the local soccer academy for another 4 weeks.
Informed Consent and Assent forms will be completed in person, original copies will be collected and stay with the Investigators, a copy of both will be given to the participants.
All other data will be collected electronically. Sensors send data directly to researcher (Chi-Ming Huang).
- Conditions
- Concussion, Head Injury Trauma
- Being tested
- Modern microelectrical mechanical systems (MEMS) head-impact sensors, Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus, Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus
- Keywords
- Soccer, Concussion, Traumatic Brain Injury, Sports Injury, Head Impact, Concussion Risk Assessment, Modern microelectrical mechanical systems
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern microelectrical mechanical systems (MEMS) head-impact sensorsDevice
Both groups will wear our smart head-impact sensor system (MEMS head-impact sensors) to measure their response to training.
Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned StimulusOther
Also called Virtual Reality (VR) Goggle use/experience
The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge.
Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned StimulusOther
Also called Virtual Reality (VR) Goggle use/experience
The Control group will also receive the same CS and the same US as trained group, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge.
| Study group | Role | What they receive |
|---|---|---|
| Trained | Active comparator | Both groups will be shown how to use the Virtual Reality goggles. The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge.
Both groups will also wear our smart head-impact sensor system to measure their response to training. Receives: Device: Modern microelectrical mechanical systems (MEMS) head-impact sensors; Other: Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus |
| Control | Active comparator | Both groups will be shown how to use the Virtual Reality goggles. The Control group will also receive the same CS and the same US, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge. Both groups will also wear our smart head-impact sensor system to measure their response to training. Receives: Device: Modern microelectrical mechanical systems (MEMS) head-impact sensors; Other: Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the accuracy of our sensors in setting personalized concussive thresholds.
We aim to capture data on head impact events or head movements from male and female human subjects. The name of the measurement tool is accelerometers or inertia measurement unit (IMU). One such example is the vector mouthguard sensor marketed by Athlete Intelligence (Seattle, WA). We are also engaged in the development of this technology. These data we will assess includes head angular velocities and accelerations. When such data is processed and assessed, we can query the data with our machine-learning algorithms in order to derive data on putative concussive threshold. The results of such queries will inform us whether concussive threshold may have a gender-specific component.
Measured: 3 months
Monitor neck stiffness of participants in 2 groups (Trained versus Control) while using virtual reality goggles.
We aim to monitor neck stiffness of participants in 2 groups. The name of the measurement tool is accelerometers or inertia measurement unit (IMU). One such example is the vector mouthguard sensor marketed by Athlete Intelligence (Seattle, WA). We are also engaged in the development of this technology. More specifically, if a pair of such sensors are affixed to a human subject, we can assess, compare, and compute from the outputs (on head angular velocities and accelerations) of the pair and determine the relative discrepancies between the output of the pair. The stiffness measure, including neck stiffness, is inversely proportional to the amount of the said discrepancies described above. The results of such comparison and computation will therefore inform us whether neck stiffness can be modified by training with virtual reality goggles.
Measured: 3 months
Optimize and finalize our training protocol
We aim to train human subjects in stiffing the neck prior to impact. The impact will be delivered in virtual reality such that the human subject is not getting a real impact. Participants in training will nevertheless acquire the neck-stiffening reflex upon "sensing" the impact in virtual reality. We, as investigators, will monitor the data on neck stiffness as described previously in our reply to comment 2. One goal of such monitoring is for us to optimize our detailed training protocol. As before in comments 1 and 2, the name of the measurement tool is accelerometers or inertia measurement unit (IMU). The expected outcome is that in the two groups of human subjects (trained vs. control as described in comment 2), the trained group will show significantly increases in neck stiffness upon impact compared with the control group.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study startJun 2021 (estimated)
- Primary completion17 Dec 2021 (estimated)
- Study completion10 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 2 groups -- Trained group and Control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi-Ming Huang
- Sponsor type
- University, hospital or other
- Collaborators
- UMKC School of Medicine
- Responsible party
- Sponsor-investigator, Chi-Ming Huang, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946747
- Sponsor's protocol ID
- 19-013
- Status last verified
- Jun 2021
- First submitted
- 12 Aug 2019
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Prevention of Concussive Injuries With Smart Technology.
- ClinicalTrials.gov ID
- NCT04946747
- Acronym / sponsor ID
- 19-013
- Conditions
- Concussion, Head Injury Trauma
- Keywords
- Soccer, Concussion, Traumatic Brain Injury, Sports Injury, Head Impact, Concussion Risk Assessment, Modern microelectrical mechanical systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chi-Ming HuangUniversity, hospital or other
- Collaborators
- UMKC School of Medicine
- Study start
- Jun 2021 (estimated)
- Primary completion
- 17 Dec 2021 (estimated)
- Study completion
- 10 Apr 2022 (estimated)
- First posted
- 1 Jul 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.
Concussions are consequences of inopportune interactions between an impact force and the head that causes the head (and brain) to move too rapidly. This project involves two parts.
- The outcome of head-impact depends upon the force and the biomechanical properties of the head-and-neck. Modern microelectrical mechanical systems (MEMS) head-impact sensors only measure the physical parameters of external forces. The researchers have developed a next-generation smart MEMS sensor fortified with artificial intelligence (AI) that can help define a personalized concussive threshold. The researchers sensor machine-learns the biomechanical properties of the participant's head-and-neck and accurately determines the likelihood for concussive injuries. The researchers first goal is to field-test the sensor in soccer players.
- Researchers hypothesize that an increase in neck stiffness should reduce concussive risks. The researchers have developed a training protocol that involves a conditioned response (CR) to increase neck stiffness during a head-impact event and thereby decrease concussion risk. The Researchers have also developed technology to monitor neck stiffness.
The smart sensor is fully integrated into the training protocol and monitors the neck stiffness to validate the effectiveness of the training. The second goal is to optimize and finalize our training protocol and conduct a field-test in soccer players.
Detailed description
The hypothesis is that MEMS sensors fortified with artificial intelligence and machine learning can incorporate individualized human factors into consideration and help to define concussive threshold for diagnosis that is personalized as in precision medicine. In laboratory tests, the prototype smart sensor the researchers built can machine-learn the biomechanical properties of the head-and-neck of the user without being programmed with that information. It then measures the magnitude of the impact against a personalized threshold of the user, in real time. These capabilities allow the smart sensor to accurately determine the potential for concussive injuries for a given individual.
The first aim is (a) to optimize and finalize the sensor into a wearable, field-test-ready prototype and (b) to conduct a field-test in soccer players in order to examine the accuracy of the sensors in setting personalized concussive thresholds.
The hypothesis is that the dynamic increase in neck stiffness should reduce concussive risks significantly. The smart sensor is fully integrated into the training in order to monitor the increase in neck stiffness and validate the effectiveness of the acquired CR in reducing concussion risks.
The second aim therefore is (a) to optimize and finalize our training protocol and (b) to conduct a field-test in soccer players.
The long-term objectives are to develop methods and technology for rapid and reliable concussion risk assessment in the field as well as for the prevention and mitigation of concussive injuries.
PROCEDURES
Part 1 of study:
Study information will be given to parents and soccer players (study participants) by Dr. Moncure and Dr. Huang at the Local soccer academy during normal hours. This will be a one-time session for approximately 1 hour, depending on questions.
The study information provided by investigators will also be recorded on video in order to assure that all parents and soccer players receive the same information even if they are not present at the meeting.
All players will be given the opportunity to participate based on inclusion and exclusion criteria.
Informed Consent and Assent will be reviewed with participants and parents by Dr. Moncure at the Local soccer academy after parents and soccer players have been fully informed of the study and their participation requirements. All participants and their parents must attend the informational session or watch the study informational video prior to participation. All study related questions will be answered by the Dr. Moncure or Dr. Huang. Completing the ICF and Assent will occur after the study informational session and will take approximately 30 minutes.
A Training session will be held to show all Local soccer academy trainers how the sensors work and how the sensors are affixed to the players. Later, the trainers will see to it that the soccer players will properly wear the sensors every time during practice. This training session will take approximately 30 minutes.
Once a participant has been enrolled, the participant can begin wearing the sensor during training or playing soccer at Local soccer academy. Sensors will be worn over a period of at least 4 weeks when the players are at the Local soccer academy. The participant has completed Part 1 at the end of 4 weeks. The purpose of Part 1 is to collect head movement data from the soccer players before concussion avoidance training.
Part 2 of study:
Randomization of participants will occur. Participants will be randomized into 2 groups -- Trained group and Control group.
Trainers will be shown how to conduct the Virtual Reality (VR) training session. Trainers will be shown proper placement of the head-impact sensor system to measure participant response to training.
After Part 1 of the study has been completed, the participants will be randomized and divided into the Trained group and the Control group. Considerations will be given to obtain the best possible age-match and gender match in the Trained group and the control group. Both groups will be shown how to use the Virtual Reality goggles. During the one to two week VR training period, both groups will be using the VR goggles. The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge. The Control group will also receive the same CS and the same US, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge. Both groups will also wear our smart head-impact sensor system to measure their response to training. One purpose of this arrangement is to provide an avenue for a double-blind analysis. A second purpose will be the provision for an age-and gender-matched control group for the study.
CR training will be carried out over a period of approximately 10 days with daily 30-minute sessions (or roughly over a period of one to two weeks). The training involves wearing the VR goggles and our smart head-impact sensor system (head sensor and body sensor), at the local soccer academy in the training area. The participant will receive virtual visual stimuli of usual soccer play as CS. The participant will also receive a mildly unpleasant auditory stimuli (such as those from a coach) as US. The training will be done in the local soccer academy training room, with only those randomized participants and their trainers present.
The Control group will also participate in VR training but will not know that they are in the Control group. All data will be kept within software that comes with the sensors and VR goggles.
Once the CR training has been completed, all participants will again wear our smart sensors whenever they are playing soccer at the local soccer academy for another 4 weeks.
Informed Consent and Assent forms will be completed in person, original copies will be collected and stay with the Investigators, a copy of both will be given to the participants.
All other data will be collected electronically. Sensors send data directly to researcher (Chi-Ming Huang).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized into 2 groups -- Trained group and Control group.
| Arm | Type | Receives |
|---|---|---|
| Trained | Active comparator | Device: Modern microelectrical mechanical systems (MEMS) head-impact sensors, Other: Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned StimulusBoth groups will be shown how to use the Virtual Reality goggles. The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge. Both groups will also wear our smart head-impact sensor system to measure their response to training. |
| Control | Active comparator | Device: Modern microelectrical mechanical systems (MEMS) head-impact sensors, Other: Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned StimulusBoth groups will be shown how to use the Virtual Reality goggles. The Control group will also receive the same CS and the same US, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge. Both groups will also wear our smart head-impact sensor system to measure their response to training. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Local soccer academy soccer player, Age 7-17,
- Agrees to participate in study, (signed Assent),
- Parent agrees to child's participation in study (signed consent)
Key exclusion criteria (3 listed)
- Any individual who does not agree to participate,
- Any individual whose parent does not agree to having their child participate,
- Individual who is unable or unwilling to wear a sensor
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 |
|---|---|---|
| Modern microelectrical mechanical systems (MEMS) head-impact sensorsBoth groups will wear our smart head-impact sensor system (MEMS head-impact sensors) to measure their response to training. | Device | Control, Trained |
| Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned StimulusAlso: Virtual Reality (VR) Goggle use/experienceThe Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge. | Other | Trained |
| Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned StimulusAlso: Virtual Reality (VR) Goggle use/experienceThe Control group will also receive the same CS and the same US as trained group, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge. | Other | Control |
Primary outcome
Examine the accuracy of our sensors in setting personalized concussive thresholds.
Time frame: 3 months
We aim to capture data on head impact events or head movements from male and female human subjects. The name of the measurement tool is accelerometers or inertia measurement unit (IMU). One such example is the vector mouthguard sensor marketed by Athlete Intelligence (Seattle, WA). We are also engaged in the development of this technology. These data we will assess includes head angular velocities and accelerations. When such data is processed and assessed, we can query the data with our machine-learning algorithms in order to derive data on putative concussive threshold. The results of such queries will inform us whether concussive threshold may have a gender-specific component.
Monitor neck stiffness of participants in 2 groups (Trained versus Control) while using virtual reality goggles.
Time frame: 3 months
We aim to monitor neck stiffness of participants in 2 groups. The name of the measurement tool is accelerometers or inertia measurement unit (IMU). One such example is the vector mouthguard sensor marketed by Athlete Intelligence (Seattle, WA). We are also engaged in the development of this technology. More specifically, if a pair of such sensors are affixed to a human subject, we can assess, compare, and compute from the outputs (on head angular velocities and accelerations) of the pair and determine the relative discrepancies between the output of the pair. The stiffness measure, including neck stiffness, is inversely proportional to the amount of the said discrepancies described above. The results of such comparison and computation will therefore inform us whether neck stiffness can be modified by training with virtual reality goggles.
Optimize and finalize our training protocol
Time frame: 5 months
We aim to train human subjects in stiffing the neck prior to impact. The impact will be delivered in virtual reality such that the human subject is not getting a real impact. Participants in training will nevertheless acquire the neck-stiffening reflex upon "sensing" the impact in virtual reality. We, as investigators, will monitor the data on neck stiffness as described previously in our reply to comment 2. One goal of such monitoring is for us to optimize our detailed training protocol. As before in comments 1 and 2, the name of the measurement tool is accelerometers or inertia measurement unit (IMU). The expected outcome is that in the two groups of human subjects (trained vs. control as described in comment 2), the trained group will show significantly increases in neck stiffness upon impact compared with the control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Chiming Huang, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Modern microelectrical mechanical systems (MEMS) head-impact sensors, Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus and Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus in people with Concussion and Head Injury Trauma, run by Chi-Ming Huang.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Dyer, MSN (816.404.1380, kim.dyer@tmcmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the accuracy of our sensors in setting personalized concussive thresholds. (time frame: 3 months). The study lists 3 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 1 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.