Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02916108
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2016-09-18
Brief Title:
Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion A Proof of Concept Study
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion A Proof of Concept Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 150000 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 071 Moreover one of the greatest concerns is the childs 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
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 071 Moreover one of the greatest concerns is the childs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None