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

NCT02916108 | Unknown

• 1 other identifier: 0333-16-RambamCTIL
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild Traumatic Brain Injury

Keywords

Concussion; Mild traumatic brain injury; EEG

Outcome Measures

Primary Outcomes (1)

• Primary objective: Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.

  Change in interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres, as calculated from the sampled EEG.

  One year

Secondary Outcomes (1)

• Secondary objective: Percentage of children with persistent post-concussion symptoms that display a decreased IHDD below 0.7 in the anterior hemispheres.

  One year

Study Arms (2)

Concussion

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

Other: Reading EEG

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.

Other: Reading EEG

Interventions

Reading EEG OTHER

EEG recording for 5 minutes (not an intervention)

Concussion; Isolated limb injury

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Related Publications (12)

• 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.

  PMID: 25144831 BACKGROUND

• 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.

  PMID: 23753087 BACKGROUND

• 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.

  PMID: 23243113 BACKGROUND

• 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.

  PMID: 8551320 BACKGROUND

• 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.

  PMID: 25347264 BACKGROUND

• 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.

  PMID: 17063314 BACKGROUND

• 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.

  PMID: 27313546 BACKGROUND

• 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.

  PMID: 27142146 BACKGROUND

• 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.

  PMID: 23805094 BACKGROUND

• 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.

  PMID: 25643158 BACKGROUND

• 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.

  PMID: 23879529 BACKGROUND

• 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.

  PMID: 26954410 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Dana Baron Shahaf, MD PhD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Baron Shahaf, MD PhD

CONTACT

+972-4-7772487; dana.barons@gmail.com

Itay Shavit, MD

CONTACT

+972-4-7774; i_shavit@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2016
• First Posted: September 27, 2016
• Study Start: October 1, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

IL (1)