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

NCT02916108 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-12-08

No results posted yet for this study

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.

Conditions

  • Concussion, Mild Traumatic Brain Injury

Interventions

OTHER

Reading EEG

EEG recording for 5 minutes (not an intervention)

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Dana Baron Shahaf, MD PhD · Rambam Health Care Campus

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916108 on ClinicalTrials.gov