Cortical Spreading Depolarization After Severe Traumatic Brain Injury

NCT03321370 | Recruiting FDA Device

• 1 other identifier: HSR 17-4400
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Preliminary evaluation of electrodes placed on the brain for recording brain activity and novel algorithms to determine cortical spreading depolarization foci of origination following severe traumatic brain injury requiring neurosurgical intervention.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Determination of foci that give rise to cortical spreading depolarizations

  2 years

Secondary Outcomes (1)

• Determine the relationship between cortical spreading depolarization foci of origination and structural pathology demonstrated on brain imaging (CT and MRI).

  2 years

Other Outcomes (1)

• Determine the association (if any) between cortical spreading depolarization foci of origination and cortical spreading depolarization frequency with relevant physiological data.

  2 years

Interventions

Continuous electrocorticography post severe traumatic brain injury requiring neurosurgical intervention DIAGNOSTIC_TEST

Continuous electrocorticography via subdural electrode strips for 1 to 3 weeks in the neuro intensive care unit following traumatic brain injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the population of severe TBI patients clinically judged to require neurosurgical intervention who present through the emergency department or upon direct transfer to the neurosurgery service at Hennepin County Medical Center. The target sample size for this preliminary study is 10 subjects.

You may qualify if:

• Patient recommended to undergo craniectomy or craniotomy for the treatment of acute TBI

You may not qualify if:

• Wound determined to be contaminated
• Decompression is performed only in the posterior fossa
• Known systemic infection
• Pregnancy

Sponsors & Collaborators

• Hennepin County Medical Center, Minneapolis: lead

Study Sites (1)

Hennepn Healthcare

Minneapolis, Minnesota, 55404, United States

RECRUITING

Related Publications (19)

• Dreier JP, Fabricius M, Ayata C, Sakowitz OW, Shuttleworth CW, Dohmen C, Graf R, Vajkoczy P, Helbok R, Suzuki M, Schiefecker AJ, Major S, Winkler MK, Kang EJ, Milakara D, Oliveira-Ferreira AI, Reiffurth C, Revankar GS, Sugimoto K, Dengler NF, Hecht N, Foreman B, Feyen B, Kondziella D, Friberg CK, Piilgaard H, Rosenthal ES, Westover MB, Maslarova A, Santos E, Hertle D, Sanchez-Porras R, Jewell SL, Balanca B, Platz J, Hinzman JM, Luckl J, Schoknecht K, Scholl M, Drenckhahn C, Feuerstein D, Eriksen N, Horst V, Bretz JS, Jahnke P, Scheel M, Bohner G, Rostrup E, Pakkenberg B, Heinemann U, Claassen J, Carlson AP, Kowoll CM, Lublinsky S, Chassidim Y, Shelef I, Friedman A, Brinker G, Reiner M, Kirov SA, Andrew RD, Farkas E, Guresir E, Vatter H, Chung LS, Brennan KC, Lieutaud T, Marinesco S, Maas AI, Sahuquillo J, Dahlem MA, Richter F, Herreras O, Boutelle MG, Okonkwo DO, Bullock MR, Witte OW, Martus P, van den Maagdenberg AM, Ferrari MD, Dijkhuizen RM, Shutter LA, Andaluz N, Schulte AP, MacVicar B, Watanabe T, Woitzik J, Lauritzen M, Strong AJ, Hartings JA. Recording, analysis, and interpretation of spreading depolarizations in neurointensive care: Review and recommendations of the COSBID research group. J Cereb Blood Flow Metab. 2017 May;37(5):1595-1625. doi: 10.1177/0271678X16654496. Epub 2016 Jan 1.

  PMID: 27317657 BACKGROUND

• Dreier JP, Woitzik J, Fabricius M, Bhatia R, Major S, Drenckhahn C, Lehmann TN, Sarrafzadeh A, Willumsen L, Hartings JA, Sakowitz OW, Seemann JH, Thieme A, Lauritzen M, Strong AJ. Delayed ischaemic neurological deficits after subarachnoid haemorrhage are associated with clusters of spreading depolarizations. Brain. 2006 Dec;129(Pt 12):3224-37. doi: 10.1093/brain/awl297. Epub 2006 Oct 25.

  PMID: 17067993 BACKGROUND

• Drenckhahn C, Windler C, Major S, Kang EJ, Scheel M, Vajkoczy P, Hartings JA, Woitzik J, Dreier JP; COSBID study group. Complications in Aneurysmal Subarachnoid Hemorrhage Patients With and Without Subdural Electrode Strip for Electrocorticography. J Clin Neurophysiol. 2016 Jun;33(3):250-9. doi: 10.1097/WNP.0000000000000274.

  PMID: 27258449 BACKGROUND

• Fabricius M, Fuhr S, Bhatia R, Boutelle M, Hashemi P, Strong AJ, Lauritzen M. Cortical spreading depression and peri-infarct depolarization in acutely injured human cerebral cortex. Brain. 2006 Mar;129(Pt 3):778-90. doi: 10.1093/brain/awh716. Epub 2005 Dec 19.

  PMID: 16364954 BACKGROUND

• Hartings JA, Bullock MR, Okonkwo DO, Murray LS, Murray GD, Fabricius M, Maas AI, Woitzik J, Sakowitz O, Mathern B, Roozenbeek B, Lingsma H, Dreier JP, Puccio AM, Shutter LA, Pahl C, Strong AJ; Co-Operative Study on Brain Injury Depolarisations. Spreading depolarisations and outcome after traumatic brain injury: a prospective observational study. Lancet Neurol. 2011 Dec;10(12):1058-64. doi: 10.1016/S1474-4422(11)70243-5. Epub 2011 Nov 3.

  PMID: 22056157 BACKGROUND

• Hartings JA, Li C, Hinzman JM, Shuttleworth CW, Ernst GL, Dreier JP, Wilson JA, Andaluz N, Foreman B, Carlson AP. Direct current electrocorticography for clinical neuromonitoring of spreading depolarizations. J Cereb Blood Flow Metab. 2017 May;37(5):1857-1870. doi: 10.1177/0271678X16653135. Epub 2016 Jan 1.

  PMID: 27286981 BACKGROUND

• Hartings JA, Shuttleworth CW, Kirov SA, Ayata C, Hinzman JM, Foreman B, Andrew RD, Boutelle MG, Brennan KC, Carlson AP, Dahlem MA, Drenckhahn C, Dohmen C, Fabricius M, Farkas E, Feuerstein D, Graf R, Helbok R, Lauritzen M, Major S, Oliveira-Ferreira AI, Richter F, Rosenthal ES, Sakowitz OW, Sanchez-Porras R, Santos E, Scholl M, Strong AJ, Urbach A, Westover MB, Winkler MK, Witte OW, Woitzik J, Dreier JP. The continuum of spreading depolarizations in acute cortical lesion development: Examining Leao's legacy. J Cereb Blood Flow Metab. 2017 May;37(5):1571-1594. doi: 10.1177/0271678X16654495. Epub 2016 Jan 1.

  PMID: 27328690 BACKGROUND

• Hartings JA, Strong AJ, Fabricius M, Manning A, Bhatia R, Dreier JP, Mazzeo AT, Tortella FC, Bullock MR; Co-Operative Study of Brain Injury Depolarizations. Spreading depolarizations and late secondary insults after traumatic brain injury. J Neurotrauma. 2009 Nov;26(11):1857-66. doi: 10.1089/neu.2009.0961.

  PMID: 19508156 BACKGROUND

• Hartings JA, Watanabe T, Bullock MR, Okonkwo DO, Fabricius M, Woitzik J, Dreier JP, Puccio A, Shutter LA, Pahl C, Strong AJ; Co-Operative Study on Brain Injury Depolarizations. Spreading depolarizations have prolonged direct current shifts and are associated with poor outcome in brain trauma. Brain. 2011 May;134(Pt 5):1529-40. doi: 10.1093/brain/awr048. Epub 2011 Apr 7.

  PMID: 21478187 BACKGROUND

• Hinzman JM, Andaluz N, Shutter LA, Okonkwo DO, Pahl C, Strong AJ, Dreier JP, Hartings JA. Inverse neurovascular coupling to cortical spreading depolarizations in severe brain trauma. Brain. 2014 Nov;137(Pt 11):2960-72. doi: 10.1093/brain/awu241. Epub 2014 Aug 24.

  PMID: 25154387 BACKGROUND

• Hinzman JM, Wilson JA, Mazzeo AT, Bullock MR, Hartings JA. Excitotoxicity and Metabolic Crisis Are Associated with Spreading Depolarizations in Severe Traumatic Brain Injury Patients. J Neurotrauma. 2016 Oct 1;33(19):1775-1783. doi: 10.1089/neu.2015.4226. Epub 2016 Mar 18.

  PMID: 26586606 BACKGROUND

• Jeffcote T, Hinzman JM, Jewell SL, Learney RM, Pahl C, Tolias C, Walsh DC, Hocker S, Zakrzewska A, Fabricius ME, Strong AJ, Hartings JA, Boutelle MG. Detection of spreading depolarization with intraparenchymal electrodes in the injured human brain. Neurocrit Care. 2014 Feb;20(1):21-31. doi: 10.1007/s12028-013-9938-7.

  PMID: 24343564 BACKGROUND

• Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.

  PMID: 18635021 BACKGROUND

• Marin JR, Weaver MD, Mannix RC. Burden of USA hospital charges for traumatic brain injury. Brain Inj. 2017;31(1):24-31. doi: 10.1080/02699052.2016.1217351. Epub 2016 Nov 10.

  PMID: 27830939 BACKGROUND

• Marin JR, Weaver MD, Yealy DM, Mannix RC. Trends in visits for traumatic brain injury to emergency departments in the United States. JAMA. 2014 May 14;311(18):1917-9. doi: 10.1001/jama.2014.3979. No abstract available.

  PMID: 24825648 BACKGROUND

• Schmidt RF, Wu C, Lang MJ, Soni P, Williams KA Jr, Boorman DW, Evans JJ, Sperling MR, Sharan AD. Complications of subdural and depth electrodes in 269 patients undergoing 317 procedures for invasive monitoring in epilepsy. Epilepsia. 2016 Oct;57(10):1697-1708. doi: 10.1111/epi.13503. Epub 2016 Aug 23.

  PMID: 27549686 BACKGROUND

• Strong AJ, Fabricius M, Boutelle MG, Hibbins SJ, Hopwood SE, Jones R, Parkin MC, Lauritzen M. Spreading and synchronous depressions of cortical activity in acutely injured human brain. Stroke. 2002 Dec;33(12):2738-43. doi: 10.1161/01.str.0000043073.69602.09.

  PMID: 12468763 BACKGROUND

• Waxweiler RJ, Thurman D, Sniezek J, Sosin D, O'Neil J. Monitoring the impact of traumatic brain injury: a review and update. J Neurotrauma. 1995 Aug;12(4):509-16. doi: 10.1089/neu.1995.12.509. No abstract available.

  PMID: 8683602 BACKGROUND

• Cramer SW, Pino IP, Naik A, Carlson D, Park MC, Darrow DP. Mapping spreading depolarisations after traumatic brain injury: a pilot clinical study protocol. BMJ Open. 2022 Jul 13;12(7):e061663. doi: 10.1136/bmjopen-2022-061663.

  PMID: 35831043 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Samuel W Cramer, MD, PhD

  University of Minnesota Neurosurgery Department; Division of Neurosurgery, Department of Surgery, Hennepin County Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel W Cramer, MD, PhD

CONTACT

612-624-6666; rnl@umn.edu

David P Darrow, MD, MPH

CONTACT

612-624-6666; rnl@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery Attending Physician

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: October 25, 2017
• Study Start: August 14, 2019
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 36 months following article publication.
• Access Criteria: To investigators who provide a methodologically sound proposal whose proposed use of data has been approved by an independent review committee for the proposed purpose. Data requests should be directed to the corresponding author of the publication that forms the basis for the data requests. Investigators will have to sign a data use agreement in order to gain access to the data.

Locations

US (1)