Concussion, Mild Traumatic Brain InjuryNCT02916108
Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study
An observational study of Concussion, Mild Traumatic Brain Injury, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Approximately 150,000 children present each year to emergency departments (EDs) in the US with concussion and many more are treated by primary care physician, or outpatient specialists. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild Traumatic Brain Injury
- What is being tested?
- Reading EEG
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2017to Dec 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: A prospective case control study will be performed. The investigators will enroll patients presented to the pediatric ED of Rambam Health Care Campus (RHCC) with symptoms of acute concussion within 24 hours of mild head injury). The control group will be consisted of previously healthy children with an isolated limb injury. Study participants will be enrolled on the basis of a convenience sample.
Who may be able to join
- Study group will include children aged 11-18 years with diagnosis of acute concussion based on the RPSQ. (Eisenberg et al., 2013; Harmon et al., 2013)
- Controls will be healthy children who will be admitted to the ED due to an isolated limb injury such as laceration, contusion or fracture and are not painful. Nonverbal or non-cooperative children will be excluded from the study.
Who cannot join
- Nonverbal or non-cooperative children.
- Lack of inform consent.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Dana Baron Shahaf, Dr., dana_bs@rambam.health.gov.il
Dana Baron Shahaf, Dr.
About this study
Approximately 150,000 children present each year to emergency departments (EDs) in the US with concussion and many more are treated by primary care physician, or outpatient specialists.
Concussion is defined as a traumatically induced transient disturbance of brain function and involves a complex pathophysiological process. There is a variety of symptoms related to concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since there is a various degree of the severity of those symptoms, the diagnosis is a subjective one and lacks sensitivity.
Read more
One major problem is that approximately one-third of the children with concussion experience ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as persistent post-concussion symptoms. A recent study that investigated the validity a 12-point PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the greatest concerns is the child's schedule return to activity.
Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it is likely to be expressed in desynchronization of delta wave activity between anterior hemispheres as seen in pathological problems related to attention and/ or working memory).
The aim of this proof-of-concept study is to find-out whether interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute concussion in children. If the investigators find that IHDD can accurately diagnose acute concussion, a second objective will be to examine whether this index can be a useful tool in the follow up of patients with persistent post-concussion symptoms.
- Conditions
- Concussion, Mild Traumatic Brain Injury
- Being tested
- Reading EEG
- Keywords
- Concussion, Mild traumatic brain injury, EEG
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading EEGOther
EEG recording for 5 minutes (not an intervention)
| Study group | Role | What they receive |
|---|---|---|
| Concussion | Study group include up to 30 children with history of concussion in the last 24 hours before admitting to emergency department.
Reading EEG. Receives: Other: Reading EEG | |
| Isolated limb injury | Cohort group include up to 30 children with history of isolated limb injury in the last 24 hours before admitting to emergency department.
Reading EEG. Receives: Other: Reading EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective: Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.
Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.
Measured: One year
Secondary outcomes (1)
Secondary objective: Percentage of children with persistent post-concussion symptoms that display a decreased IHDD below 0.7 in the anterior hemispheres.
Percentage of children with persistent post-concussion symptoms that display a decreased IHDD below 0.7 in the anterior hemispheres.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start1 Oct 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Concussion, Mild Traumatic Brain InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Baron Shahaf, MD PhD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916108
- Sponsor's protocol ID
- 0333-16-RambamCTIL
- Status last verified
- Dec 2023
- First submitted
- 18 Sep 2016
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
DeMatteo C, McCauley D, Stazyk K, Harper J, Adamich J, Randall S, Missiuna C. Post-concussion return to play and return to school guidelines for children and youth: a scoping methodology. Disabil Rehabil. 2015;37(12):1107-12. doi: 10.3109/09638288.2014.952452. Epub 2014 Aug 21.
PubMed 25144831Eisenberg MA, Andrea J, Meehan W, Mannix R. Time interval between concussions and symptom duration. Pediatrics. 2013 Jul;132(1):8-17. doi: 10.1542/peds.2013-0432. Epub 2013 Jun 10.
PubMed 23753087Harmon KG, Drezner JA, Gammons M, Guskiewicz KM, Halstead M, Herring SA, Kutcher JS, Pana A, Putukian M, Roberts WO. American Medical Society for Sports Medicine position statement: concussion in sport. Br J Sports Med. 2013 Jan;47(1):15-26. doi: 10.1136/bjsports-2012-091941.
PubMed 23243113King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
PubMed 8551320Baldea JD. In response to: time to re-think the Zurich Guidelines? A critique on the consensus statement on concussion in Sport: the 4th International Conference on Concussion in Sport, held in Zurich, November 2012. Clin J Sport Med. 2014 Nov;24(6):521-2. doi: 10.1097/JSM.0000000000000157. No abstract available.
PubMed 25347264Potter S, Leigh E, Wade D, Fleminger S. The Rivermead Post Concussion Symptoms Questionnaire: a confirmatory factor analysis. J Neurol. 2006 Dec;253(12):1603-14. doi: 10.1007/s00415-006-0275-z. Epub 2006 Oct 24.
PubMed 17063314Shahaf G. A Possible Common Neurophysiologic Basis for MDD, Bipolar Disorder, and Schizophrenia: Lessons from Electrophysiology. Front Psychiatry. 2016 Jun 1;7:94. doi: 10.3389/fpsyt.2016.00094. eCollection 2016.
PubMed 27313546Shahaf G. Migraine as dysfunctional drive reduction: Insight from electrophysiology. Med Hypotheses. 2016 Jun;91:62-66. doi: 10.1016/j.mehy.2016.04.017. Epub 2016 Apr 11.
PubMed 27142146Shahaf G, Pratt H. Thorough specification of the neurophysiologic processes underlying behavior and of their manifestation in EEG - demonstration with the go/no-go task. Front Hum Neurosci. 2013 Jun 24;7:305. doi: 10.3389/fnhum.2013.00305. eCollection 2013.
PubMed 23805094Vargas G, Rabinowitz A, Meyer J, Arnett PA. Predictors and prevalence of postconcussion depression symptoms in collegiate athletes. J Athl Train. 2015 Mar;50(3):250-5. doi: 10.4085/1062-6050-50.3.02. Epub 2015 Feb 2.
PubMed 25643158West TA, Marion DW. Current recommendations for the diagnosis and treatment of concussion in sport: a comparison of three new guidelines. J Neurotrauma. 2014 Jan 15;31(2):159-68. doi: 10.1089/neu.2013.3031. Epub 2013 Oct 16.
PubMed 23879529Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
PubMed 26954410
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02916108
- Acronym / sponsor ID
- 0333-16-RambamCTIL
- Conditions
- Concussion, Mild Traumatic Brain Injury
- Keywords
- Concussion, Mild traumatic brain injury, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Sep 2016 (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.
Approximately 150,000 children present each year to emergency departments (EDs) in the US with concussion and many more are treated by primary care physician, or outpatient specialists.
Concussion is defined as a traumatically induced transient disturbance of brain function and involves a complex pathophysiological process. There is a variety of symptoms related to concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since there is a various degree of the severity of those symptoms, the diagnosis is a subjective one and lacks sensitivity.
One major problem is that approximately one-third of the children with concussion experience ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as persistent post-concussion symptoms. A recent study that investigated the validity a 12-point PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the greatest concerns is the child's schedule return to activity.
Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it is likely to be expressed in desynchronization of delta wave activity between anterior hemispheres as seen in pathological problems related to attention and/ or working memory).
The aim of this proof-of-concept study is to find-out whether interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute concussion in children. If the investigators find that IHDD can accurately diagnose acute concussion, a second objective will be to examine whether this index can be a useful tool in the follow up of patients with persistent post-concussion symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion | – | Other: Reading EEGStudy group include up to 30 children with history of concussion in the last 24 hours before admitting to emergency department. Reading EEG. |
| Isolated limb injury | – | Other: Reading EEGCohort group include up to 30 children with history of isolated limb injury in the last 24 hours before admitting to emergency department. Reading EEG. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A prospective case control study will be performed. The investigators will enroll patients presented to the pediatric ED of Rambam Health Care Campus (RHCC) with symptoms of acute concussion within 24 hours of mild head injury). The control group will be consisted of previously healthy children with an isolated limb injury. Study participants will be enrolled on the basis of a convenience sample.
Key inclusion criteria (2 listed)
- Study group will include children aged 11-18 years with diagnosis of acute concussion based on the RPSQ. (Eisenberg et al., 2013; Harmon et al., 2013)
- Controls will be healthy children who will be admitted to the ED due to an isolated limb injury such as laceration, contusion or fracture and are not painful. Nonverbal or non-cooperative children will be excluded from the study.
Key exclusion criteria (2 listed)
- Nonverbal or non-cooperative children.
- Lack of inform consent.
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 |
|---|---|---|
| Reading EEGEEG recording for 5 minutes (not an intervention) | Other | Concussion, Isolated limb injury |
Primary outcome
Primary objective: Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.
Time frame: One year
Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.
1 secondary outcome
Secondary objective: Percentage of children with persistent post-concussion symptoms that display a decreased IHDD below 0.7 in the anterior hemispheres.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 25144831DeMatteo C, McCauley D, Stazyk K, Harper J, Adamich J, Randall S, Missiuna C. Post-concussion return to play and return to school guidelines for children and youth: a scoping methodology. Disabil Rehabil. 2015;37(12):1107-12. doi: 10.3109/09638288.2014.952452. Epub 2014 Aug 21.
- Background: PubMed 23753087Eisenberg MA, Andrea J, Meehan W, Mannix R. Time interval between concussions and symptom duration. Pediatrics. 2013 Jul;132(1):8-17. doi: 10.1542/peds.2013-0432. Epub 2013 Jun 10.
- Background: PubMed 23243113Harmon KG, Drezner JA, Gammons M, Guskiewicz KM, Halstead M, Herring SA, Kutcher JS, Pana A, Putukian M, Roberts WO. American Medical Society for Sports Medicine position statement: concussion in sport. Br J Sports Med. 2013 Jan;47(1):15-26. doi: 10.1136/bjsports-2012-091941.
- Background: PubMed 8551320King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.
- Background: PubMed 25347264Baldea JD. In response to: time to re-think the Zurich Guidelines? A critique on the consensus statement on concussion in Sport: the 4th International Conference on Concussion in Sport, held in Zurich, November 2012. Clin J Sport Med. 2014 Nov;24(6):521-2. doi: 10.1097/JSM.0000000000000157. No abstract available.
- Background: PubMed 17063314Potter S, Leigh E, Wade D, Fleminger S. The Rivermead Post Concussion Symptoms Questionnaire: a confirmatory factor analysis. J Neurol. 2006 Dec;253(12):1603-14. doi: 10.1007/s00415-006-0275-z. Epub 2006 Oct 24.
- Background: PubMed 27313546Shahaf G. A Possible Common Neurophysiologic Basis for MDD, Bipolar Disorder, and Schizophrenia: Lessons from Electrophysiology. Front Psychiatry. 2016 Jun 1;7:94. doi: 10.3389/fpsyt.2016.00094. eCollection 2016.
- Background: PubMed 27142146Shahaf G. Migraine as dysfunctional drive reduction: Insight from electrophysiology. Med Hypotheses. 2016 Jun;91:62-66. doi: 10.1016/j.mehy.2016.04.017. Epub 2016 Apr 11.
- Background: PubMed 23805094Shahaf G, Pratt H. Thorough specification of the neurophysiologic processes underlying behavior and of their manifestation in EEG - demonstration with the go/no-go task. Front Hum Neurosci. 2013 Jun 24;7:305. doi: 10.3389/fnhum.2013.00305. eCollection 2013.
- Background: PubMed 25643158Vargas G, Rabinowitz A, Meyer J, Arnett PA. Predictors and prevalence of postconcussion depression symptoms in collegiate athletes. J Athl Train. 2015 Mar;50(3):250-5. doi: 10.4085/1062-6050-50.3.02. Epub 2015 Feb 2.
- Background: PubMed 23879529West TA, Marion DW. Current recommendations for the diagnosis and treatment of concussion in sport: a comparison of three new guidelines. J Neurotrauma. 2014 Jan 15;31(2):159-68. doi: 10.1089/neu.2013.3031. Epub 2013 Oct 16.
- Background: PubMed 26954410Zemek R, Barrowman N, Freedman SB, Gravel J, Gagnon I, McGahern C, Aglipay M, Sangha G, Boutis K, Beer D, Craig W, Burns E, Farion KJ, Mikrogianakis A, Barlow K, Dubrovsky AS, Meeuwisse W, Gioia G, Meehan WP 3rd, Beauchamp MH, Kamil Y, Grool AM, Hoshizaki B, Anderson P, Brooks BL, Yeates KO, Vassilyadi M, Klassen T, Keightley M, Richer L, DeMatteo C, Osmond MH; Pediatric Emergency Research Canada (PERC) Concussion Team. Clinical Risk Score for Persistent Postconcussion Symptoms Among Children With Acute Concussion in the ED. JAMA. 2016 Mar 8;315(10):1014-25. doi: 10.1001/jama.2016.1203.
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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.
Dana Baron Shahaf, MD PhD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild Traumatic Brain Injury, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 2 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 8 Dec 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dana Baron Shahaf, MD PhD (+972-4-7772487, dana.barons@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective: Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG. (time frame: One year). 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 NCT02916108, which also lists 12 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 8 Dec 2023.