Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study
NCT ID: NCT02916108
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2017-10-01
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Concussion
Study group include up to 30 children with history of concussion in the last 24 hours before admitting to emergency department.
Reading EEG.
Reading EEG
EEG recording for 5 minutes (not an intervention)
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.
Reading EEG
EEG recording for 5 minutes (not an intervention)
Interventions
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Reading EEG
EEG recording for 5 minutes (not an intervention)
Eligibility Criteria
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Inclusion Criteria
* 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
* Lack of inform consent.
11 Years
18 Years
ALL
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Dana Baron Shahaf, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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Dana Baron Shahaf, Dr.
Role: primary
References
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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.
Eisenberg 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.
Harmon 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.
King 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.
Baldea 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.
Potter 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.
Shahaf 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.
Shahaf 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.
Shahaf 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.
Vargas 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.
West 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.
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.
Other Identifiers
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0333-16-RambamCTIL
Identifier Type: -
Identifier Source: org_study_id