Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study

Rambam Health Care Campus

Status: Enrolling

Conditions: Concussion, Mild Traumatic Brain Injury

Treatments: Other: Reading EEG

Study type: Observational

Funder types: Other

Identifiers

NCT02916108

0333-16-RambamCTIL

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Concussion

Description:

Study group include up to 30 children with history of concussion in the last 24 hours before admitting to emergency department. Reading EEG.

Treatment:

Other: Reading EEG

Isolated limb injury

Description:

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.

Treatment:

Other: Reading EEG