Post Concussion SymptomsPhase 1NCT02118220
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
A Phase 1 study testing Concussion Questionnaire in people with Post Concussion Symptoms, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Post Concussion Symptoms
- What is being tested?
- Concussion Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 1
- 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 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients aged 5-21 years of age presenting for repair of orthopedic traumatic injury. Orthopedic traumatic injury will be defined as any traumatic injury resulting from a fall, collision (struck by or struck against), vehicle accident, assault or bike-related injury or fracture.
Who cannot join
- Patients who do not speak English as their first language, or who are unable to respond to the survey's questions on their own will be excluded from study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.
Read the detailed description
Phase I's specific aim is to estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.
The first phase of this study requires a member of the research team to administer a paper questionnaire to all eligible, consented orthopedic surgery patients in either the Pre-operative Clinic or in the Day Surgery Unit over a period of four months. The research member will only approach adolescents that are scheduled for repair of orthopedic traumatic injury as defined in the inclusion criteria. The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. If the participant scores higher than a 0 on the SCAT3 the results will be conveyed to the surgeon prior to the start of the scheduled surgical procedure. A copy of the completed SCAT3 will also be placed in the medical record. The decision to continue with surgery and need to possibly refer the patient to the Boston Children's Hospital Sports Concussion Clinic after the SCAT3 will remain at the surgeon's discretion.
Information will be gathered from the questionnaire and the SCAT3, then entered into the REDcap database under a de-identified subject number.
- Conditions
- Post Concussion Symptoms
- Being tested
- Concussion Questionnaire
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concussion QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Concussion Questionnaire | Other | The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. Receives: Other: Concussion Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Concussion SymptomsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynne Ferrari, Boston Children's Hospital
- Investigators
- Lynne Ferrari, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118220
- Sponsor's protocol ID
- IRB-P00011568
- Status last verified
- Dec 2016
- First submitted
- 16 Apr 2014
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
PubMed 16983222Gessel LM, Fields SK, Collins CL, Dick RW, Comstock RD. Concussions among United States high school and collegiate athletes. J Athl Train. 2007 Oct-Dec;42(4):495-503.
PubMed 18174937SCAT3. Br J Sports Med. 2013 Apr;47(5):259. No abstract available.
PubMed 23479480Child SCAT3. Br J Sports Med. 2013 Apr;47(5):263. No abstract available.
PubMed 23479481McCrea M, Hammeke T, Olsen G, Leo P, Guskiewicz K. Unreported concussion in high school football players: implications for prevention. Clin J Sport Med. 2004 Jan;14(1):13-7. doi: 10.1097/00042752-200401000-00003.
PubMed 14712161Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics. 2009 Jan;123(1):114-23. doi: 10.1542/peds.2008-0309.
PubMed 19117869Zhou Y, Kierans A, Kenul D, Ge Y, Rath J, Reaume J, Grossman RI, Lui YW. Mild traumatic brain injury: longitudinal regional brain volume changes. Radiology. 2013 Jun;267(3):880-90. doi: 10.1148/radiol.13122542. Epub 2013 Mar 12.
PubMed 23481161
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
- ClinicalTrials.gov ID
- NCT02118220
- Acronym / sponsor ID
- IRB-P00011568
- Conditions
- Post Concussion Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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.
The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.
Detailed description
Phase I's specific aim is to estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.
The first phase of this study requires a member of the research team to administer a paper questionnaire to all eligible, consented orthopedic surgery patients in either the Pre-operative Clinic or in the Day Surgery Unit over a period of four months. The research member will only approach adolescents that are scheduled for repair of orthopedic traumatic injury as defined in the inclusion criteria. The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. If the participant scores higher than a 0 on the SCAT3 the results will be conveyed to the surgeon prior to the start of the scheduled surgical procedure. A copy of the completed SCAT3 will also be placed in the medical record. The decision to continue with surgery and need to possibly refer the patient to the Boston Children's Hospital Sports Concussion Clinic after the SCAT3 will remain at the surgeon's discretion.
Information will be gathered from the questionnaire and the SCAT3, then entered into the REDcap database under a de-identified subject number.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concussion Questionnaire | Other | Other: Concussion QuestionnaireThe questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients aged 5-21 years of age presenting for repair of orthopedic traumatic injury. Orthopedic traumatic injury will be defined as any traumatic injury resulting from a fall, collision (struck by or struck against), vehicle accident, assault or bike-related injury or fracture.
Key exclusion criteria (1 listed)
- Patients who do not speak English as their first language, or who are unable to respond to the survey's questions on their own will be excluded from study participation.
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 Questionnaire | Other | Concussion Questionnaire |
Primary outcome
Estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.
Time frame: 4 months
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 6 Dec 2016.
- Background: PubMed 16983222Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
- Background: PubMed 18174937Gessel LM, Fields SK, Collins CL, Dick RW, Comstock RD. Concussions among United States high school and collegiate athletes. J Athl Train. 2007 Oct-Dec;42(4):495-503.
- Background: PubMed 23479480SCAT3. Br J Sports Med. 2013 Apr;47(5):259. No abstract available.
- Background: PubMed 23479481Child SCAT3. Br J Sports Med. 2013 Apr;47(5):263. No abstract available.
- Background: PubMed 14712161McCrea M, Hammeke T, Olsen G, Leo P, Guskiewicz K. Unreported concussion in high school football players: implications for prevention. Clin J Sport Med. 2004 Jan;14(1):13-7. doi: 10.1097/00042752-200401000-00003.
- Background: PubMed 19117869Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics. 2009 Jan;123(1):114-23. doi: 10.1542/peds.2008-0309.
- Background: PubMed 23481161Zhou Y, Kierans A, Kenul D, Ge Y, Rath J, Reaume J, Grossman RI, Lui YW. Mild traumatic brain injury: longitudinal regional brain volume changes. Radiology. 2013 Jun;267(3):880-90. doi: 10.1148/radiol.13122542. Epub 2013 Mar 12.
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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.
Lynne Ferrari, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Concussion Questionnaire in people with Post Concussion Symptoms, run by Boston Children's Hospital 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 1 inclusion and 1 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 6 Dec 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118220, which also lists 7 linked publications.
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 6 Dec 2016.