Fixation, OcularNCT05432752
Concussion Pen Screening Tool
A study testing Concussion Pen in people with Fixation, Ocular and Brain Concussion, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Fixation, Ocular, Brain Concussion
- What is being tested?
- Concussion Pen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 25 Jan 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inclusion Criteria for both control and study cohorts, unless stated otherwise below
- Patients cognitively 11 to 18 years of age.
- Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population.
- Patients with a history of concussion at any previous point in time (no time limits to this date).
- Patients with no history of concussion and being seen at CM PT/OT for other diagnoses for control population.
- Patients able to give verbal assent or consent (dependent on patient cognitive age), and Legally Authorized Representatives (LAR)s able to give verbal parental permission.
- English-speaking families.
Who cannot join
- Patients not within the inclusion criteria as outlined above.
- Patients with congenital vestibular dysfunction will not be included.
- Patients diagnosed with dyslexia or Attention Deficit Hyperactive Disorder (ADHD) will not be included.
- Non-English-speaking families.
- Wards of the State will not be approached for this study.
- Patients with a previous diagnosis of strabismus or convergence insufficiency will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Use of the Concussion Pen in Evaluating Ocular-motor Function in the Concussed and Non-concussed Populations Ages 11 to 18 Years Old.
To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized. This randomization will help to control for evaluation fatigue on the part of study participants.
Read the detailed description
This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
This will be a multi-disciplinary team with members of Physical Therapy (PT)/ Occupational Therapy (OT), Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), and Doctor of Philosophy(PhD)s who specialize in concussion assessment. This study will include a population of concussed patients as well as non-concussed patients (controls) who will be seen in CM clinics per standard of care.
- Conditions
- Fixation, Ocular, Brain Concussion
- Being tested
- Concussion Pen
- Keywords
- Ocular motor function, Concussion
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concussion PenDevice
Device will measure the distance from the eye to the Concussion Pen for ocular motor functions.
| Study group | Role | What they receive |
|---|---|---|
| Concussed Subjects | Experimental | Subjects with known history of concussion will be evaluated using current clinical evaluation and also using the Concussion Pen. Receives: Device: Concussion Pen |
| Non-Concussed Subjects | Experimental | Subjects with no known history of concussion will be evaluated using current clinical evaluation for a concussion and also using the Concussion Pen. Receives: Device: Concussion Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concussion Pen versus Current Clinical Evaluation
Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start28 Jul 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fixation, OcularStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Thorne, Children's Mercy Hospital Kansas City
- Investigators
- Andrea Thorne, PT, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432752
- Sponsor's protocol ID
- STUDY00002250
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2022
- Last updated
- 2 Mar 2023
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Concussion Pen in Evaluating Ocular-motor Function in the Concussed and Non-concussed Populations Ages 11 to 18 Years Old.
- ClinicalTrials.gov ID
- NCT05432752
- Acronym / sponsor ID
- STUDY00002250
- Conditions
- Fixation, Ocular, Brain Concussion
- Keywords
- Ocular motor function, Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 27 Jun 2022 (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.
To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized. This randomization will help to control for evaluation fatigue on the part of study participants.
Detailed description
This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
This will be a multi-disciplinary team with members of Physical Therapy (PT)/ Occupational Therapy (OT), Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), and Doctor of Philosophy(PhD)s who specialize in concussion assessment. This study will include a population of concussed patients as well as non-concussed patients (controls) who will be seen in CM clinics per standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.
| Arm | Type | Receives |
|---|---|---|
| Concussed Subjects | Experimental | Device: Concussion PenSubjects with known history of concussion will be evaluated using current clinical evaluation and also using the Concussion Pen. |
| Non-Concussed Subjects | Experimental | Device: Concussion PenSubjects with no known history of concussion will be evaluated using current clinical evaluation for a concussion and also using the Concussion Pen. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Inclusion Criteria for both control and study cohorts, unless stated otherwise below
- Patients cognitively 11 to 18 years of age.
- Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population.
- Patients with a history of concussion at any previous point in time (no time limits to this date).
- Patients with no history of concussion and being seen at CM PT/OT for other diagnoses for control population.
Key exclusion criteria (6 listed)
- Patients not within the inclusion criteria as outlined above.
- Patients with congenital vestibular dysfunction will not be included.
- Patients diagnosed with dyslexia or Attention Deficit Hyperactive Disorder (ADHD) will not be included.
- Non-English-speaking families.
- Wards of the State will not be approached for this study.
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 |
|---|---|---|
| Concussion PenDevice will measure the distance from the eye to the Concussion Pen for ocular motor functions. | Device | Concussed Subjects, Non-Concussed Subjects |
Primary outcome
Concussion Pen versus Current Clinical Evaluation
Time frame: 1 year
Concussion Pen is able to determine concussed patients to the same level as current clinical evaluation.
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 2 Mar 2023.
- 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.
Andrea Thorne, PT principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concussion Pen in people with Fixation, Ocular and Brain Concussion, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 7 inclusion and 6 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Concussion Pen versus Current Clinical Evaluation (time frame: 1 year). 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 2 Mar 2023.