Clinical trial NCT02916108: Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study
Official title: Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Concussion, Mild Traumatic Brain Injury
Keywords: Concussion
Mild traumatic brain injury
EEG
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Nonverbal or non-cooperative children.
* Lack of inform consent.

Primary outcomes:
measure: Primary objective: Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.
timeFrame: One year
Secondary outcomes:
measure: Secondary objective: Percentage of children with persistent post-concussion symptoms that display a decreased IHDD below 0.7 in the anterior hemispheres.
timeFrame: One year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Dana Baron Shahaf, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zemek 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.