deltatrials
Unknown OBSERVATIONAL NCT00258505

Monitoring Brain Activity in Human Brain Injury

Incidence, Nature and Consequences of Cortical Depolarizations in Human Brain Injury From Trauma and Ischemia: The COSBID Study

Sponsor: Soroka University Medical Center

Updated 7 times since 2017 Last updated: Jul 31, 2007 Completion: Sep 30, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Aneurysmal Subarachnoid Hemorrhage and Cerebral Hemorrhage, this trial is ongoing. The trial is conducted by Soroka University Medical Center and has accumulated 7 data snapshots since 2026. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

Cortical spreading depression (CSD) is a wave of mass neuronal firing and neuronal and glial depolarisation which propagates through grey matter in the central nervous system in response to a pathologic stimulus, at a rate of between 1 and 5 mm per minute. First described by Leão in 1944 as a sudden depression of ECoG amplitude spreading across the cortex of the rabbit (Leao, A. A. P. 1944), CSD can be elicited in experimental animals by chemical, electrical, and mechanical stimuli, with varying degrees of ease. CSD provoked in healthy, normally perfused neural tissue does not induce persistent metabolic stress or cellular damage, and indeed such induction of CSD in animal experiments may confer protection against the adverse effects of a subsequent ischaemic insult (Kobayashi, S. et al. 1995). In animal models of focal cerebral ischaemia, usually induced by occlusion of the middle cerebral artery, a spontaneous phenomenon occurs around the periphery of the core territory, with electrophysiological features essentially identical with CSD, and similar capacity to propagate across cerebral cortex. Designated "peri-infarct depolarisation" (PID), this event is associated with infarct expansion, or recruitment of at-risk cortical territory into the expanding core, and has been shown capable of causing this...

Cortical spreading depression (CSD) is a wave of mass neuronal firing and neuronal and glial depolarisation which propagates through grey matter in the central nervous system in response to a pathologic stimulus, at a rate of between 1 and 5 mm per minute. First described by Leão in 1944 as a sudden depression of ECoG amplitude spreading across the cortex of the rabbit (Leao, A. A. P. 1944), CSD can be elicited in experimental animals by chemical, electrical, and mechanical stimuli, with varying degrees of ease. CSD provoked in healthy, normally perfused neural tissue does not induce persistent metabolic stress or cellular damage, and indeed such induction of CSD in animal experiments may confer protection against the adverse effects of a subsequent ischaemic insult (Kobayashi, S. et al. 1995).

In animal models of focal cerebral ischaemia, usually induced by occlusion of the middle cerebral artery, a spontaneous phenomenon occurs around the periphery of the core territory, with electrophysiological features essentially identical with CSD, and similar capacity to propagate across cerebral cortex. Designated "peri-infarct depolarisation" (PID), this event is associated with infarct expansion, or recruitment of at-risk cortical territory into the expanding core, and has been shown capable of causing this expansion, in the absence of therapeutic intervention. Indeed it has been hypothesized that glutamate release may be involved in PID generation, and that excitotoxicity may accomplish detrimental effects via this route (Hossmann, K. A. 1994), (Obrenovitch, T. P. and Urenjak, J. 1997). Some experimental neuroprotection treatments for stroke act to decrease the incidence of PID (Iijima, T. et al. 1992;Chen, Q. et al. 1993;Busch, E. et al. 1996).

In traumatic and ischaemic (especially in middle cerebral artery occlusion and aneurysmal subarachnoid haemorrhage) brain injury in humans, a phase of delayed deterioration often associated with severe and refractory brain swelling develops between 2 and 5 days after the initial ictus, and is associated with poor or fatal outcome. The cause and mechanism of this deterioration remain poorly understood, and the possibility exists that CSD/PID events might contribute to deterioration.

To date, CSD or PID have been reported in only ten human subjects in two papers (Mayevsky, A. et al. 1996; Strong, A. J. et al. 2002). Strong et al. reported that transient ECoG suppressions suggestive of depolarisations are common - but by no means universal - after brain injury in humans. Sub-dural ECoG electrode strips were placed in 14 patients who had undergone craniotomy for trauma or intracranial hemorrhage; monitoring was for up to 60 h following the injury. Five of these patients (36%) showed patterns of ECoG depression consistent with PID/CSD in brain regions adjacent to the primary injury.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotUnknown Status~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Unknown

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Unknown Status

    Phase: NANone

  2. Jan 2017 — Apr 2018 [monthly]

    Unknown Status NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Soroka University Medical Center
Data source: Soroka University Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .